header logo image


Page 6«..5678..20..»

Archive for the ‘Stem Cell Negative’ Category

The MicroRNA Reverse Transcription market to grow on a prudent note from 2020 to 2030 – KYT24

Tuesday, November 17th, 2020

MicroRNA are small endogenous RNA that regulates gene-expression post-transcriptionally. MicroRNA are abundantly found in the mammalian types and target approximately 60% of the genes of the human and other mammals. MiRNA reverse transcription are crucial regulators of gene expression and promising candidates for biomarker development. A single miRNA can target hundreds of mRNAs and influence the expression of many genes. Further, miRNA reverse transcription involved in many allergies diseases including eosinophilic esophagitis, asthma and many others which is likely to increase the demand for MicroRNA Reverse Transcription. Current methodologies used for MicroRNA reverse transcription such as RNA-sequencing, microarrays and quantitative PCR.

Increasing prevalence of Cancer, neurological disorder and others are expected to drive the MicroRNA reverse transcription market. MicroRNA reverse transcriptase is found to be associated with immune system, cancer stem cell and androgen receptor expression properties in triple negative breast cancer. In addition, MicroRNA reverse transcriptase market is expected to rise exponentially due to further development in genomics technologies and computational approaches. Further, therapeutics demonstration in preclinical studies using these molecules is anticipated to increase the R&D investment in the coming years. Furthermore, there are various kits available such as the TaqMan, MicroRNA reverse transcriptase is specifically designed to generate specific cDNA, for the use with the TaqMan MicroRNA Assays is also expected to increase the growth of MicroRNA reverse transcriptase market.

To remain ahead of your competitors, request for a sample[emailprotected]

https://www.persistencemarketresearch.com/samples/31453

Accurate delivery of these molecules to an intracellular site such as nucleus and cytosol and also limited research infrastructure in emerging market are expected to hinder the growth of MicroRNA reverse transcriptase market.

The global MicroRNA reverse transcription market is classified on the basis of components type, methods, application, end user and region.

Based on Components Types, MicroRNA Reverse Transcription Market is segmented into the following:

By Products Type:

By Services Type:

Based on Methods, MicroRNA Reverse Transcription Market is segmented into the following:

Based on Application, MicroRNA Reverse Transcription Market is segmented into the following:

Based on End User, MicroRNA Reverse Transcription Market is segmented into the following:

Global MicroRNA Reverse Transcription market is segmented on the basis of components type, methods, application, end user and region. On the basis of product type, consumables are expected to represent the leading share in the MicroRNA Reverse Transcription market. On the basis of methods, quantitative PCR is expected to increase the demand for MicroRNA Reverse Transcription which is used to diagnose diseases, match criminals crimes and identify bacteria. Furthermore, on the basis of application, shifting focus on pipeline research for infectious and cancer attributed to their high occurrence and failure rate of existing treatment processes can further propel growth followed by neurological and cardiovascular disorders. On the basis of end user, academic and research institutes are expected to enhance effectiveness of microRNA drug technology which is likely to witness maximum growth forecast period.

To receive extensive list of important regions, Request Methodology here @

https://www.persistencemarketresearch.com/methodology/31453

Geographically, the MicroRNA Reverse Transcription market is segmented into regions such as Latin America, Europe, North America, South Asia, East Asia Middle East & Africa and Oceania. North America is projected to emerge as prominent market in the MicroRNA Reverse Transcription market due to several factors such as increasing prevalence of chronic and acute disease, access to advanced technologies and rising demand for preventive medical care followed by Europe. Asia pacific is the expected to show lucrative growth due to increasing access to advanced technologies, geriatric population, increasing disposable incomes and also demand for advanced diagnostic procedure. However, unmet needs for MicroRNA Reverse Transcription is expected to drive the Middle East and Africa.

Some of the major key players competing in the MicroRNA Reverse Transcription market are Sigma Aldrich Corp., Thermo Fisher Scientific, Inc., Agilent Technologies, Illumina, Inc., Bio-Rad Laboratories Inc., System Biosciences LLC, HTG Molecular Diagnostics, Inc., GeneCopoeia, Inc. and New England Biolabs, Inc.

You Can Request for TOC Here @https://www.persistencemarketresearch.com/toc/31453

Explore Extensive Coverage of PMR`s

Life Sciences & Transformational HealthLandscape

About us:

Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics andmarket research methodologyto help businesses achieve optimal performance.

To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMRs collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.

Contact us:

Naved BegPersistence Market ResearchAddress 305 Broadway, 7th Floor, New York City,NY 10007 United StatesU.S. Ph. +1-646-568-7751USA-Canada Toll-free +1 800-961-0353Sales[emailprotected]

Link:
The MicroRNA Reverse Transcription market to grow on a prudent note from 2020 to 2030 - KYT24

Read More...

Global Circulating Tumor Cells Market 2020 Analysis and In-Depth Research on Market Dynamics, consumption by Regional data, Trends, Investigation and…

Tuesday, November 17th, 2020

Latest updated Report gives analysis of Circulating Tumor Cells market overview, scope, market risks, market driving force and market opportunities. Circulating Tumor Cells competitive situation, sales, revenue and global market share of top manufacturers working in Circulating Tumor Cells industry are analyzed clearly by landscape contrast

The Global Circulating Tumor Cells Market divides the industry on the basis of the regions by growth, product types and applications, over the forecast period (2020-2027) of the Circulating Tumor Cells market. It analyzes every majorfacts of the global Circulating Tumor Cells by specifications of the product, restraints, challenges, andgrowth opportunities. Company profiles of the major leading player with Circulating Tumor Cells investment forecast, latest technology trends,and future forecast. Detailed global understanding of the Circulating Tumor Cells market based on present and future size(revenue) and Circulating Tumor Cells market prediction plot in the form of a list of charts and tables, pie-charts to assist aspirants and major market players in making significant and growing choices.

Download Free Sample Pdf Report @ https://www.globalmarketers.biz/report/life-sciences/2015-2027-global-circulating-tumor-cells-industry-market-research-report,-segment-by-player,-type,-application,-marketing-channel,-and-region/146935#request_sample

The research mainly covers Circulating Tumor Cells market in North America (United States, Canada and Mexico), Circulating Tumor Cells Europe industry (Germany, France, UK, Russia and Italy), Asia-Pacific (Southeast Asia, China, Korea, India and Japan), Circulating Tumor Cells South America industry (Brazil, Argentina, Colombia), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa). The Circulating Tumor Cells report also performs SWOT (Strengths, Weaknesses, Opportunities, and Threats) with XX CAGR values, and XX USD of past(2015-2019) and Circulating Tumor Cells forecast(2020-2027) on the basis of growth and market condition following with the size of Circulating Tumor Cells market.

The Global Circulating Tumor Cells market reportcomprises variouskey manufacturers, application analysis and type analysis:

Key players of the global Circulating Tumor Cells market:

BioceptAdnagenNanostring TechnologiesApoCellCanopus BioscienceMiltenyi BiotechVitatexIkonisysRarecells DiagnosticsCreatv MicrotechIV Diagnostics

Market Segment Analysis

By Types:

Ex-Vivo Positive SelectionIn-Vivo Positive SelectionNegative SelectionMicrochips & Single Spiral Micro Channel

By Applications:

Tumorigenesis ResearchEMT Biomarkers DevelopmentCancer Stem Cell ResearchOthers

InquiryHere For More Details https://www.globalmarketers.biz/report/life-sciences/2015-2027-global-circulating-tumor-cells-industry-market-research-report,-segment-by-player,-type,-application,-marketing-channel,-and-region/146935#inquiry_before_buying

Segments of the Circulating Tumor Cells Report:

Global Circulating Tumor Cells market report figure out a detailed analysis of key Circulating Tumor Cells market players by referencing their company profiles, supply/demand study, sales margin, gross margin and year to year revenue to have Circulating Tumor Cells industry better share over the globe. Circulating Tumor Cells market report also includes development.

The Global Circulating Tumor Cells industry research report analyses the supply, sales, production, and market status comprehensively. manufacturing market shares and sales market shares are analyzed along with the analysis of capacity, production, sales, and revenue.

Table Of Content Described:

1. Circulating Tumor Cells Industry Synopsis

2. Global Circulating Tumor Cells Market Size by Segmentation (2020-2027)

3. Circulating Tumor Cells Leading Manufacturers Company Profiles

4. Global Circulating Tumor Cells Market Competitive Study by Players

5. US Circulating Tumor Cells Market Development Status and Overview

6. Europe Circulating Tumor Cells Market Improvement Status and Overview

7. Africa Circulating Tumor Cells Market Development Status and Overview

8. South-America Circulating Tumor Cells Market Improvement Status and Overview

9. Asia-pacific Circulating Tumor Cells Market Development Status and Overview

10. Southeast Asia Circulating Tumor Cells Improvement Status and Overview

11. Circulating Tumor Cells Market Forecast by Regional Analysis, And By Segmentation (2020-2027)

12. Dynamics of Circulating Tumor Cells Market

13. Circulating Tumor Cells Market Growth Factors Study

14. Research Conclusions

15. Appendix

Explore Detailed Information, Table Of Content https://www.globalmarketers.biz/report/life-sciences/2015-2027-global-circulating-tumor-cells-industry-market-research-report,-segment-by-player,-type,-application,-marketing-channel,-and-region/146935#table_of_contents

Follow this link:
Global Circulating Tumor Cells Market 2020 Analysis and In-Depth Research on Market Dynamics, consumption by Regional data, Trends, Investigation and...

Read More...

Live Cell Imaging Market By Applications, Types, New Technology Opportunity Analysis And Forecast: 2020 2028 – TechnoWeekly

Tuesday, November 17th, 2020

The global Live Cell Imaging Market study offers a compilation of the current, historical, and future outlook of the industry as well as the factors responsible for market growth. With a SWOT analysis, the business study highlights the weaknesses, strengths, opportunities, and threats of each Live Cell Imaging Market player in a comprehensive way.

Sample Copy of This Report: https://www.quincemarketinsights.com/request-sample-64777?utm_source=SA/technoweekly

Under the COVID-19 outbreak analysis, this report provides analysis of import, supply chain, and export to future influence on the industry and regional government policies. Enterprise competition pattern, detailed analysis about market status, advantages and disadvantages of enterprise products, macroeconomic policies and regional industrial layout characteristics, industry development trends have also been included. The trends of product sales channel will be offered as well.

Considering COVID-19, this report offers a complete and exhaustive analysis on how the epidemic has pushed transformation and reform in the industry. The market study can help understand the market expansion and strategies for business accordingly. In the strategy analysis, it gives insights from market positioning marketing channel to potential growth strategies, thereby providing an in-depth analysis for new entrants or existing competitors in the Live Cell Imaging industry.

Key Players: Becton, Dickinson and Company, Carl Zeiss, and Leica Microsystems..

The market analysis on the Live Cell Imaging offers a birds eye view of the current proceeding within the Live Cell Imaging Market. The market analysis report has incorporated an analysis of various factors that augment the markets growth. It constitutes restraints, trends, and drivers that transform the market in either a negative orpositive manner.

Live Cell Imaging Market

Get ToC for the overview of the premium report @ https://www.quincemarketinsights.com/request-toc-64777?utm_source=SA/technoweekly

This market analysis also offers the scope of different segments and applications that can actually impact the market in the future. The thorough information is based on present trends and historic milestones. The market analysis mentions the volume of sales by region from 2015 to 2026. A thorough evaluation of the limitations included in the market analysis portrays the drivers and gives room for strategic planning.

Global Live Cell Imaging Market: Segment Analysis

Each type offers information about return sover the forecast period of 2018 to 2028. The sales method segment also offers revenue by volume and sales over the forecast period of 2018 to 2028. Understanding the segments helps in classifying the importance of various factors that support market growth.

Following are the segmentation covered by the market study: By Product (Equipment, Consumables, and Software and Services), By Application (Cell Biology, Developmental Biology, Stem Cell Biology, Drug Discovery)

Global Live Cell Imaging Market: Regional Analysis

The market analysis report includes a thorough study of various factors that determine regional growth such as environmental, economic, social political status, technology, and region. Market analysis has studied the data of sales, revenue, and manufacturers of each region. The market analysis provides region-wise volume and revenue for the forecast period of 2016 to 2028. This market analysis will support the market participants to understand the potential worth of investment in a particular region.

Region- wise Analysis of the Global Live Cell Imaging Market covers: North America Europe Asia Pacific Middle East and Africa South America

Make an Enquiry for purchasing this Report @ https://www.quincemarketinsights.com/enquiry-before-buying-64777?utm_source=SA/AF

Global Live Cell Imaging Market: Competitive Landscape

This market analysis report classifies numerous key manufacturers of the industry. It supports the reader in understanding the policies and collaborations that the industry participants are focusing on in order to combat competition in the industry. The comprehensive market analysis offers a note worthy microscopic look at the industry. The market analysis can classify the footprints of the manufacturers by giving the global revenue of manufacturers and sales by manufacturers, and the global price of manufacturers over the forecast period of 2018 to 2028.

Major Aspects covered in the Report are

Further, the report provides niche insights for a decision about every possible segment, helping in the strategic decision-making process and market size estimation of the Live Cell Imaging Market on a regional and global basis. Unique research designed for market size estimation and forecast is used for the identification of major companies operating in the market with related developments. The report has an exhaustive scope to cover all the possible segments, helping every stakeholder in the Live Cell Imaging Market.

Reasons for buying this report:

Why Do Companies Trust QMI?

ABOUT US:

QMI has the most comprehensive collection of market research products and services available on the web. We deliver reports from virtually all major publications and refresh our list regularly to provide you with immediate online access to the worlds most extensive and up-to-date archive of professional insights into global markets, companies, goods, and patterns.

Contact:

Quince Market Insights

Office No- A109

Pune, Maharashtra 411028

Phone: APAC +91 706 672 4848 / US +1 208 405 2835 / UK +44 1444 39 0986

Email: [emailprotected]

Web: https://www.quincemarketinsights.com

See the original post:
Live Cell Imaging Market By Applications, Types, New Technology Opportunity Analysis And Forecast: 2020 2028 - TechnoWeekly

Read More...

Neurogenesis: The Missing Link When Treating Depression – The Great Courses Daily News

Tuesday, November 17th, 2020

ByPeter M. Vishton, PhD,William & MaryEdited by Kate Findley and proofread byAngelaShoemaker, The Great Courses DailyNew research shows that exercise and SSRIs both help with reducing depression. Photo By Tero Vesalainen / ShutterstockDefying Conventional Wisdom

It may be that the key to reducing depression is to make more neurons. This is called neurogenesis.

The conventional wisdom for many decades in neuroscience was that the brain produced neurons only early in development. By later childhoodcertainly by the onset of pubertyit was believed that your brain had produced all of the neurons that it ever would.

Its long been understood that the brain continues to alter the patterns of connections between existing neurons throughout our lives and the strengths of those existing connections are altered by our experiences. In terms of the production of completely new neurons, that was presumed not to happen in the human brain.

If a peripheral neuron is destroyedfor example, if someone suffers a bad injury to a fingerit will often heal itself. In the central nervous system, though, neurons seem not to regenerate after they are destroyed.

This is, to a large extent, true, but several teams of researchers in the 1980s and 1990s found evidence for adult neurogenesisthe creation of new neurons. The results were first found not in humans, actually, but in songbirds and, later, rats.

The basic technique for doing this is ingenious. A mildly radioactive label is injected into the bloodstream of the animal; that is, a label thats designed to adhere to the animals DNA.

In later microscopic imaging of the brain tissue, the labeled DNA can then be seen. When the body makes a new cellany cells now, not just brain cellsit does so via a process called mitosis.

The cell makes a copy of its own DNA, along with other critical internal components of the cell, and then dividessplitting in two to create a copy of itself. After a cell has undergone this mitosis, the labeled DNA looks different in very predictable ways. Essentially you can see where the brain has been making new cells during the time between the labeling injections and when the imaging takes place.

Amazingly, the brains of many animals seem to make new neurons on a pretty regular basis. The original work was done with songbirdsbirds like canarieswho typically learn new songs every spring.

As they undergo this seasonal learning process, their brains change in size substantially to support this new learning. The new cells are created, recruited into learning circuits, and then used just like older cells are.

In humans, it seems that new neurons are actually not produced in most brain regions. They might be, but, if they are, the neurogenesis is very slow and perhaps rare. There is now good evidence, however, that a neuron creation process takes place in at least two parts of the human brain; parts where rapid learning seems to take place.

The first is called the striatum; this is a subcortical part of the brain thats central to implementing your responses to positive and negative reinforcements. When fighting procrastination, for example, you get that shot of pleasure when you complete something.

That nucleus accumbens is one subpart of this larger striatum region. Just like songbirds, this is a part of the brain where continual learning and restructuring takes place.

The other region where rapid neurogenesis seems to take place in humans is in the hippocampus. This is a part of the brain thats critical for many important cognitive functions.

Our internal mental map of the surrounding environment seems to be implemented in this part of the brainincluding our sense of where we are on that mental map. Our ability to form new long-term memories is implemented in the hippocampus as well.

People who suffer damage to the hippocampus can often remember many things that took place in their earlier life, but, after suffering the hippocampus injury, they lack the ability to remember new names, new places, new eventsthis is a condition called anterograde amnesia.

A particular region of the hippocampus seems to hang on to a stock of undifferentiated neuronal cellsessentially stem cells. When it uses some of them, the stock is replenished.

Throughout our lives, these stem cells are converted into functioning neurons and incorporated into the regular function of the hippocampus. The precise details of how this takes place is still a bit of a mystery.

What we do know is that neurogenesis takes place. Something else we know is that it doesnt take place nearly as much in people who suffer from depression symptoms.

Several studies have found that people who suffer from major depression for several months actually have measurable smaller hippocampus regions. If the hippocampus reduces the rate at which it produces new neurons for an extended period, it will begin to shrink. This directly fits this notion that depression is related to a low rate of neuronal production in the hippocampus and other areas of the brain associated with learning and arousal.

We also know that patients who take antidepressant medications dont typically experience an immediate recoverytheir mood doesnt immediately improve when they start to take a SSRI drug. Usually, the positive impact of the medication doesnt kick in for several weeks.

This is a bit surprising if depression is all about the neurotransmitters. The effects of those on serotonin and other neurotransmitters really shouldnt take many weeks; it should take place over the course of hours or days at the most.

Interestingly, it also takes a few weeks for the brain to start producing new neurons more rapidly again. The neurogenesis and depressive symptoms seem to follow about the same timeline. Again, it seems that depression might be very much about neuron production.

All of this sounds like the story might be winding down. Depression is strongly associated with reduction in neurogenesis. Increase neurogenesismaybe with drugs, or maybe with exerciseand depression goes away.

Peter M. Vishton is Associate Professor of Psychology at William & Mary. He earned his PhD in Psychology and Cognitive Science from Cornell University. Before joining the faculty of William & Mary, he taught at Northwestern University and served as the program director for developmental and learning sciences at the National Science Foundation.

Read more:
Neurogenesis: The Missing Link When Treating Depression - The Great Courses Daily News

Read More...

Bioprinted therapeutic offers novel solution for treating Type 1 Diabetes – Canada NewsWire

Tuesday, September 22nd, 2020

Current treatments for diabetes are costlywith diabetes-related healthcare costs in Canada expected to increase to over $16.9 billion by 2020.They carry costs for patients as well, frequently in the form of negative side effects. One conventional method of treating T1D is the daily administration of insulin to manage blood sugar levels. This treatment is different from the control of a pancreatic cell, meaning patients are more likely to experience the debilitating consequences of improper glucose management. These can include damage to the eyes, nerves, kidneys, heart, and later life health complications.

To regain the benefits of working pancreatic cells, a more elegant approach is to simply replace those cells by transplanting insulin-producing pancreatic tissue into a T1D patient. However, this is not a viable long-term solution. A finite supply of donor working pancreatic tissue available to transplant, coupled with the requirement for the patient to administer life-long anti-rejection drugs that can themselves lead to significant health complications, means that an alternative is needed. An ideal solution is treating T1D with insulin made by pancreatic cells in the patient's own body, like a transplant but in a way that hides those cells from the patient's immune system so anti-rejection drugs are not needed.

In a collaborative project with Dr. Timothy Kieffer of the University of British Columbia (UBC), Vancouver-based company Aspect Biosystems is producing a bioprinted therapeutic of pancreatic cells surrounded by a protective layer that can be implanted in T1D patients. This bioprinted therapeutic will contain genetically modified stem-cell derived pancreatic cells that will take over the production of insulin and thereby regulate blood sugar levels naturally. This could serve as an effective and scalable therapy for individuals with T1D, allowing them to move away from both daily insulin injections and long-term treatment with anti-rejection drugs.

"This generous and strategic support from Genome BC allows us to strengthen our existing collaboration with Dr. Kieffer, a world leader in the development of stem cell-derived pancreatic beta cells for clinical use," said Dr. Sam Wadsworth, Chief Scientific Officer, Aspect Biosystems. "By working together, we look forward to developing a bioprinted pancreatic therapeutic that could significantly improve the quality of life for millions of people globally."

This collaboration, supported through Genome BC's GeneSolve program, represents a novel technological and genomics-based approach that will circumvent the shortcomings of existing methods. "This therapeutic design thoughtfully addresses the risks that current treatments pose to patients and incorporates genomics tools to test the system and make it safer," says Dr. Pascal Spothelfer, President and CEO, Genome BC. "It could represent a big step forward for patients and for the healthcare system."

About Genome British Columbia:

Genome BC is a not-for-profit organization supporting world-class genomics research and innovation to grow globally competitive life sciences sectors and deliver sustainable benefits for British Columbia, Canada and beyond. The organization's initiatives are improving the lives of British Columbians by advancing health care in addition to addressing environmental and natural resource challenges. In addition to scientific programming, Genome BC works to integrate genomics into society by supporting responsible research and innovation and foster an understanding and appreciation of the life sciences among educators, students and the public. http://www.genomebc.ca

About Aspect Biosystems:

Aspect Biosystems is a privately held biotechnology company combining the power of microfluidics and 3D bioprinting to fuel medical research and the development of bioprinted therapeutics. By adopting Aspect's microfluidic 3D bioprinting platform and collaborating within Aspect's network, researchers worldwide are accelerating the development and commercialization of 3D bioprinted tissues. In addition, Aspect is advancing its internal regenerative medicine programs focused on metabolic diseases and musculoskeletal injuries and disorders and partnering with key industry players to bring bioprinted therapeutics to the clinic. Learn more at http://www.aspectbiosystems.com

SOURCE Genome British Columbia

For further information: Jennifer Boon, Communications Manager, Sectors, Genome BC, Mobile: 778.327.8374, Email: [emailprotected], @genomebc #genomebc

http://www.genomebc.ca

Read the original post:
Bioprinted therapeutic offers novel solution for treating Type 1 Diabetes - Canada NewsWire

Read More...

Oncologie Announces New Data and Analyses from Clinical Programs and Name Change to OncXerna Therapeutics – GlobeNewswire

Tuesday, September 22nd, 2020

OncXernas RNA-based biomarker platform successfully identified responders versus non-responders in trials with late-stage cancer patients

Interim results from a Phase 2 trial of bavituximab with KEYTRUDA (pembrolizumab) demonstrates a 19% overall response rate (ORR)and 43% (3/7) ORR from an exploratory analysis in a biomarker-driven subgroup of advanced gastric cancer patients

OncXernas RNA-based biomarker panel predicts enhanced response in a Phase 1b trial of navicixizumab in late-stage ovarian cancer patients. Patients in thebiomarker positive panel achieved a 70% ORR, and excludedall who had progressive disease, compared with a 31% ORR for patients in the biomarker negativepanel

WALTHAM, Mass., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Oncologie, Inc., a precision medicine company using an innovative RNA-based biomarker platform to predict patient responses for potentially first-in-class targeted oncology therapies, today announced new data and analyses from its lead clinical programs, bavituximab and navicixizumab. On the basis of these positive data, the company also announced its rebranding to OncXerna Therapeutics, Inc., a change that reinforces the companys focus on using its RNA-based approach to guide novel, targeted treatments to specific people with cancer.

With a deep understanding of the tumor microenvironment biology at the RNA-level through our novel biomarker panel, we aim to dramatically improve clinical outcomes by matching patients to therapies with a mechanism of action that targets that specific biology, said Laura Benjamin, Ph.D., President and Chief Executive Officer at OncXerna Therapeutics. Todays results demonstrate a clear ability of our first panel to distinguish responders versus non-responders in our bavituximab and navicixizumab programs, and we are excited to deploy this approach in the next prospectively-defined trials that could support registration.

Interim results from Phase 2 (ONCG100) trial of bavituximab and KEYTRUDA

Trial design and background:

The Phase 2 (ONCG100) trial is a multicenter, open-label, single-arm global trial designed to assess the safety, tolerability, and antitumor activity of the investigational agent bavituximab, a chimeric monoclonal antibody that targets phosphatidylserine, in combination with KEYTRUDA, Mercks anti-PD-1 therapy, in patients with advanced gastric and gastroesophageal cancer who have progressed on or after at least one prior standard therapy. Bavituximab previously demonstrated clinical activity in a post-hoc subset analysis in patients with non-small cell lung cancer (NSCLC) who were given a PD-1 inhibitor following bavituximab treatment, suggesting that a treatment combination of bavituximab and a PD-1 inhibitor could generate similar activity in a prospective clinical trial. In addition to measuring safety and antitumor activity in this trial, OncXerna is deploying its proprietary RNA biomarker platform (TME Panel-1) to identify patients based on their response to treatment and the dominant biology of their tumor microenvironment with the potential to dramatically improve outcomes in the next, prospectively designed trial.

Approximately 80 patients in the U.S., United Kingdom, South Korea and Taiwan are planned for enrollment in two separate groups of patients: Checkpoint inhibitor-nave and checkpoint inhibitor-relapsed. The trial is continuing to enroll both groups with planned updates from all patients during the first half of 2021.

Interim results:

Interim results provided today, from the first 36 patients enrolled and with a post-baseline scan in the checkpoint inhibitor-nave group, include the following:

Next steps:

These data are being presented at the European Society for Molecular Oncology (ESMO) Virtual Congress 2020 taking place September 19-21, 2020.

OncXerna plans to conduct additional clinical trials designed to prospectively enrich for TME Panel-1 biomarker positive patients, as well as to explore additional solid tumor types.

OncXerna biomarker analysis from Phase 1b trial evaluating navicixizumab in ovarian cancer

Previously announced data and background:

OncXernas navicixizumab is a bispecific antibody designed to inhibit both Delta-like ligand 4 (DLL4) in the Notch cancer stem cell pathway as well as vascular endothelial growth factor (VEGF). Interim data from a Phase 1b dose escalation and expansion trial of navicixizumab plus paclitaxel in 44 platinum-resistant ovarian cancer patients who had failed more than two prior therapies and/or received prior Avastin (bevacizumab) therapy were presented virtually at the 2020 Society of Gynecologic Oncology (SGO) Annual Meeting in May 2020. Treatment with navicixizumab and paclitaxel demonstrated an ORR of 43%in all patients, and 64% and 33% in bevacizumab-nave, and bevacizumab pre-treated patients, respectively. Treatment-related adverse events were manageable and included hypertension (58%), headache (29%), fatigue (26%) and pulmonary hypertension (18%).

Updated biomarker analyses and results:

Using its RNA-based biomarker TME Panel-1, OncXerna recently analyzed patient tissue samples obtained from 28 of the 44 patients from the Phase 1b trial. Results from this analysis revealed the following:

Next steps:

As a result of these analyses, OncXerna plans to conduct additional clinical trials designed to prospectively enrich for TME Panel-1 biomarker positive patients with ovarian cancer who are platinum-resistant and Avastin-experienced to support registration, as well as to explore additional solid tumor types.

About Bavituximab

Bavituximab is an investigational antibody that reverses immune suppression by inhibiting phosphatidylserine (PS) signaling and is currently in Phase 2 clinical trials to treat a specific subset of patients with advanced gastric cancer to improve their response to anti-PD-1 treatment. The mechanism of action of bavituximab is to block tumor immune suppression signaling from PS to multiple immune cell receptor families (e.g., TIMs and TAMs). The dominant biology targeted by bavituximab may be relevant for patients with many types of solid tumors whose immune systems are too suppressed to benefit from currently available immune oncology therapies. Our clinical trials currently combine bavituximab with KEYTRUDA to test the hypothesis that relieving immunosuppression can enhance responses to checkpoint inhibitors. Bavituximab is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced gastric cancer.

About Navicixizumab

Navicixizumab is an investigational anti-DLL4/VEGF bispecific antibody that has demonstrated antitumor activity in patients who have progressed on Avastin (bevacizumab) in a Phase 1a/b clinical trial. The U.S. Food and Drug Administration granted Fast Track designation to navicixizumab for the treatment of high-grade ovarian, primary peritoneal or fallopian tube cancer in patients who have received at least three prior therapies and/or prior treatment with Avastin. OncXerna is targeting patients whose dominant tumor biology is driven by angiogenesis with a focus beyond VEGF to include broader anti-angiogenic pathways. Navicixizumab is an investigational agent that has not been licensed or approved anywhere globally, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced ovarian cancer.

About OncXerna Therapeutics

OncXerna is aiming to deliver next-generation precision medicine for a larger group of cancer patients by leveraging the companys deep understanding of how to prospectively identify patients based on the dominant, RNA-based biology of their tumor microenvironments. This allows OncXerna to pair those patients with OncXernas clinical-stage therapies and known mechanism of action that directly address these biologies, to dramatically improve patient outcomes. For more information on OncXerna, please visit oncxerna.com/

About OncXernas RNA-based Biomarker Platform

Existing precision medicines target only approximately 10% of cancersthose with gene mutations or oncogenic drivers for a small number of genes. Using its proprietary biomarker platform, OncXerna is leveraging the companys deep understanding of tumor biology at the RNA level to identify the dominant biology underlying a patients cancer. OncXernas first biomarker panel is specific to the tumor microenvironment (TME Panel-1). Initial results from TME Panel-1 reveal 4 different dominant biologies, demonstrating the presence of specific patient subgroups and their predictive value in responding to treatment. OncXerna is further optimizing the biomarker platforms tumor microenvironment panel through multiple research collaborations, including a collaboration with Moffitt Cancer Center.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Investor and Media Contact:

Ashley R. RobinsonLifeSci Partners, LLCarr@lifesciadvisors.com

Go here to read the rest:
Oncologie Announces New Data and Analyses from Clinical Programs and Name Change to OncXerna Therapeutics - GlobeNewswire

Read More...

How the single product brand trend could be an environmental home run for the beauty industry – GlobalCosmeticsNews

Tuesday, September 22nd, 2020

As beauty professionals, Id hazard a guess that were all well acquainted, and more than a little embarrassed, about our industrys negative association with environmental issues. As one of the worlds most prolific offenders of plastic waste, we are, despite ongoing and progressive initiatives and packaging developments, one of the worst culprits of single-use products destined for landfill.

So, what about the effect of the increasing popularity of single-product beauty launches? Rather than single use, although they are creeping into the mix, the recent upsurge in single product skincare regimes is becoming a popular marketing tactic for brands and also creating a new breed of skincare founders capitalizing on the popularity of the new trend. In terms of skincare, it seems that maximalism is out, and minimalism is in.

Augustinus Bader kickstarted the movement with the launch of his stem cell moisturizer, The Cream, last year. The launch came without bells and whistles, no add on items and the range was notable for its minimalist offering just one product. The skincare guru has seemingly paved the way. Founders of cult beauty brand Summer Fridays got into game in 2018 with one product the Jet Lag Mask (although I wonder how thats faring in the current climate). While theyve since expanded to a core product range of six, the mask was the hero, and only, sell-out offering for some time.

But what effect does this new skincare approach have in terms of sustainability in comparison to its multi-step predecessor? The more is more, previously much-loved, approach to skincare promotes shelves packed with products aimed at 12-step programs to create perfect skin. This generates, to put it simply, a mass of trash. Multiple bottles of what are likely potions and lotions more a marketers dream, and an environmentalists nightmare, than a skin care holy grail. But would we use less of each bottle, and therefore limit the turnover of throw-away packaging?

Meanwhile, while the latest en vogue trend on the block, single product skincare, has been lauded as a minimalist approach to perfect skin. While some could argue that using one product will promote a much higher usage, therefore a faster rotation of treasure to trash, if having to choose between the two youd obviously lean towards the manufacturing of fewer bottles, tubes and, ultimately,waste. Less is more, as they say. And with the nature of the shopper being to increasingly seek out the new, consumers across all target market groups baby boomers to gen z are also desperately searching for efficacious products that also fulfil their desire to be a green buyer.

Craigs Resurfacing Compoundseems to have hit the nail on the head. Sold out in 48 hours, the serum was two-years in the making and is said to cut beauty regimes in half with its tantalizing mix of ingredients she pulled out the big guns; retinol, antioxidants, glycolic acid and lactic acids it also comes encased in a full recyclable bottle.

With COVID-19 teaching the world to slow down and take a breath, the same could be said for our skincare routines. As stated by Vogue, a more considered approach to beauty is both needed and being lapped up by consumers. The upsurge in single-product launches is seemingly capitalizing on a desire for less is more and causing a marketing furore to boot. Less production, less waste, and, put simply, a swift U-turn from the maximalist approach of old. Get the packaging right recycledandrecyclable if you please and the industry could be on to a winner both commercially and environmentally.

The rest is here:
How the single product brand trend could be an environmental home run for the beauty industry - GlobalCosmeticsNews

Read More...

$14.6M Grant to Explore a Therapy to Control HIV Without Meds – POZ

Tuesday, September 15th, 2020

In nearly 40 years of the HIV epidemic, only two people have likely been cured of the virus. Both scenarios resulted from stem cell transplants needed to fight blood cancers such as leukemia. Inspired by these two cases, a team of scientists is studying a multipronged way to potentially control HIV without medication. It involves two different genetic alterations of immune cells and with a safer method of stem cell transplants, also referred to as bone marrow transplants, a procedure that is generally toxic and dangerous.

The research is being funded by a five-year $14.6 million grant from the National Institutes of Health. The scientists coleading the preclinical studies are Paula Cannon, PhD, a distinguished professor of molecular microbiology and immunology at the Keck School of Medicine of the University of Southern California, and Hans-Peter Kiem, MD, PhD, who directs the stem cell and gene therapy program at the Fred Hutchinson Cancer Research Center, also known as Fred Hutch. According to a Keck School of Medicine press release, the two other main partners are David Scadden, MD, a bone marrow transplant specialist and professor at Harvard University and the Harvard Stem Cell Institute, and the biotechnology company Magenta Therapeutics.

In the HIV cure scenariosinvolving the so-called Berlin and London patientsboth men received stem cell transplants from donors with a natural genetic mutation that made them resistant to HIV. Specifically, their genes resulted in immune cells that lack CCR5 receptors on their surface (HIV latches onto these receptors to infect cells). Unfortunately, this method isnt viable for the nearly 38 million people worldwide living with HIV. Not only is it expensive, toxic and riskyit involves wiping out the patients immune system and replacing it with the new immune cellsbut it also requires matched donors who are CCR5 negative. According to the press release, about 1% of the population have this mutation.

With funding from this new grant, researchers hope to overcome these challenges in several ways. First, Cannon has already developed a gene-editing method to remove the CCR5 receptors from a patients own stem cells. She now hopes to further genetically engineer stem cells so they release antibodies that block HIV.

Our engineered cells will be good neighbors, Cannon said in the press release. They secrete these protective molecules so that other cells, even if they arent engineered to be CCR5 negative, have some chance of being protected.

Fred Hutchs Kiem will use CAR-T therapya new method of genetically modifying immune cells that is emerging out of cancer researchwith the goal of creating T cells that attack HIV-infected cells.

In addition, other scientists involved in the federal grant aim to develop less toxic methods of bone marrow transplantationfor example, by reducing the amount of chemotherapy required and speeding up the process of creating the new immune system.

The research finding could translate to other illnesses, such as cancer, sickle cell anemia and autoimmune disorders.

A home run would be that we completely cure people of HIV, Cannon said. What Id be fine with is the idea that somebody no longer needs to take anti-HIV drugs every day because their immune system is keeping the virus under control so that it no longer causes health problems and, importantly, they cant transmit it to anybody else.

For the latest on the cure cases, see Famed London Man Probably Cured of HIV from earlier this year. And in related news, see $14M Federal Grant to Research CAR-T Gene Therapy to Cure HIV.

More here:
$14.6M Grant to Explore a Therapy to Control HIV Without Meds - POZ

Read More...

Takeda opens cell therapy manufacturing facility tucked right in its Boston R&D hub – Endpoints News

Tuesday, September 15th, 2020

When Takeda unveiled its translational cell therapy engine early last year, the Japanese pharma made it clear the crew, under Novartis vet Stefan Wildt, is going all the way: clinical expertise, bioengineering chops, world-class collaborations, plus chemistry, manufacturing and control.

The final piece of the puzzle has now fallen in place, with the opening of a 24,000 square-foot cell therapy manufacturing facility at its R&D headquarters in Boston.

In that early space, having it situated in proximity to our teams is quite powerful, Chris Arendt, head of the oncology therapeutic area unit, told Endpoints News. When you think about it, the process defines very much the medicine and the cell therapy space

Designed to produce clinical-grade material from discovery through pivotal Phase IIb trials, the site will support five ongoing pacts. They include pluripotent stem cell work with Kyoto University Nobel laureate Shinya Yamanaka, gamma delta T cell research with Adrian Hayday and his biotech, armored CAR-Ts with Koji Tamada at Noile-Immune Biotech, next-gen CARs with Memorial Sloan Ketterings Michel Sadelain, and finally CAR-NK with Katy Rezvani at MD Anderson.

With three programs now in the clinic, Takeda is now picking two more to test in humans in 2021, Arendt said. While each research partnership has taken on its own bespoke approach to manufacturing up to now, the new facility will provide a central spot to lock down the process development as close to the final product as possible.

At the forefront are TAK-007, an allogeneic CD19-targeted CAR-NK being tested in Phase I/II for relapsed or refractory non-Hodgkins lymphoma; TAK-940, 19(T2)28z1xx CAR-T cells featuring a next-gen signaling domain from MSK; and TAK-102, a cytokine and chemokine armored CAR-T directed at GPC3-expressing previously treated solid tumors. The latter two are in first-in-human trials.

Having a dedicated facility scales the operations up so that the team can simultaneously advance multiple programs, he added.

Before the Covid-19 pandemic sucked out all the oxygen in the room, the booming cell therapy markets demand for physical infrastructure captured considerable attention. Gileads Kite constructed its own viral vector manufacturing center in order to leave no stone unturned. Contract manufacturers like Catalent were snapping up space, and even Deerfield got into the game with a splashy, $1.1 billion entrance.

The way hes built the team now grown to well over 150 scientists the learnings from any one program can be quickly applied to the whole portfolio, Wildt noted.

We wanted to place the engine team at that sweet spot between late-stage discovery and rapidly putting forward innovative ideas and concepts into clinical translation, he said. It was just a concept a few years ago. And now we can partner with hospitals and patients and really see hopefully we can be successful on their behalf.

Continued here:
Takeda opens cell therapy manufacturing facility tucked right in its Boston R&D hub - Endpoints News

Read More...

Robots can now store energy like we store fat, and they dont even need to eat pizza – SYFY WIRE

Tuesday, September 8th, 2020

More and more robo-tech is evolving in an ironic turn that goes against many of the cold metal worlds in science fiction, where flesh has been taken over by machine. Maybe the most unexpected biomimetic literally mimicking biological creatures technology is a robot battery that stores energy like fat.

Sorry, Baymax, but robots will actually lose weight with a new "fat battery" (tech throughout history has often shed bulk with each upgrade).University of Michigan professor Nicholas Kotov a professor of chemical engineering, materials science and engineering, and macromolecular science and engineering has developed a zinc battery that could really level up the function of everything from nurse and server droids to delivery drones to micro- and nanobots. Smaller but much more energy-dense than the typical lithium ion battery, it can power a robot just as biological fat reserves can keep us going.

Such multifunctional batteries require mechanical strength, toughness, and stiffness.They should also be resilient against delamination, Kotov, who recently co-authored a study published in Science Robotics, told SYFY WIRE. Combining high-energy density with new mechanical properties was made possibleby designing new material for an ion-conducting membrane separating cathode and anode.This is how the batteries acquire these mechanical properties.The membrane between them was also designed with inspiration from biology; its nanofibrous structure is nearly identical to cartilage.

Kotov and his team demonstrated the power of these batteries (below) by creating a worm that resembles a robo-maggot and an epic scorpion that could possibly take down Scorponok in a Transformers death match.

Lithium ion batteries have nothing on these. Hydroxide ions passed on by a zinc electrode at the cathode (positive end) travel through that artificial cartilage to reach the anode (negative end) and transfer to the next battery. They are inflammable, unlike the electrolytes that can catch fire in lithium ion batteries. Aramid nanofibers in the cartilage are extraordinarily tough and can actually be upcycled from used body armor, while the gel component of it is water-based. Never mind that the battery itself is mostly nontoxic and costs much less to manufacture than that lithium ion one in your smartphone.

Kotov heads a lab with a focus on developing biomimetic nanostructures, and his research team wanted to figure out a more efficient way of storing energy in robots. Bots can be held back by the weight, cost, and overall restrictiveness of the usual batteries. Living organisms store energy very differently from batteries. Humans and other creatures have fat cells distributed all over the body, holding on to reserves of lipids that are burned when there is not enough energy intake to sustain them. There is no fat storage sac, which is basically what a battery is to a robot. The biomorphic batteries developed in Kotovs lab translate biology into technology.

Fat gets too much of a negative rap. Besides being an instant energy reserve, it protects internal organs, influences hormone and stem cell production, and functions as built-in thermal insulation.

These biological concepts can be put in the foundation of the batteries for robots, said Kotov. This is exactly what we have done in this project.We distributed the batteries over the entire body of the robot and made them multifunctional.Besides storing energy, our batteries also protect robot organs.

The only downside of the battery is that it can only keep up high capacity for about 100 cycles, compared to a lithium ion batterys average of 500. Zinc is the culprit because it ends up forming spikes that mean doom for the artificial cartilage membrane and the life of the battery. At least there should be no problem recycling and replacing the materials. Eventually, fat batteries could replace the entire exterior of a robot for an unreal 72 times more power capacity than one lithium ion battery. But would that impact the size of a robot? And with that, where it would be able to go and what tasks it would be capable of? Not according to Kotov.

Robots with biomorphic fat-like batteries do not need to be enormous, he said. In fact they are slimmer, lighter, and more agile than the original ones because we removed the bulky cumbersome part.The potential drawback is that this energy storage becomes more complex, but is the tradeoff for greater efficiency and range.

So these robots are more likely to deliver your pizza than eat it, and they wont even let it get cold.

See the original post here:
Robots can now store energy like we store fat, and they dont even need to eat pizza - SYFY WIRE

Read More...

Magenta Therapeutics Named Co-Recipient of Grant from the National Institutes of Health to Explore Use of Novel Targeted Conditioning Agents with Gene…

Tuesday, September 8th, 2020

NIH grant funds an interdisciplinary effort among researchers from University of Southern California; University of Washington and Fred Hutchinson Cancer Research Center; Harvard University and Massachusetts General Hospital; the Ragon Institute; and Magenta Therapeutics

Magenta will utilize its tool CD45 and CD117 antibody-drug conjugate (ADC) conditioning agents, as well as its stem cell biology platform to identify the optimal strategy for curative immune system transplant in patients with HIV

Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients, today announced it is part of a multi-project, broad-based research effort awarded a five-year, $14.6 million U19 grant from the National Institutes of Health (NIH) to explore gene- and cell-based approaches to advance research into curing HIV.

This cross-institutional research program brings together leaders in the fields of gene editing, HIV and stem cell transplant. The team, which includes researchers from the University of Southern California, the University of Washington, the Fred Hutchinson Cancer Research Center, Harvard University, Massachusetts General Hospital; the Ragon Institute and Magenta Therapeutics, will explore novel hematopoietic stem and progenitor cell (HSPC) engineering and transplantation approaches aimed at achieving complete remission of HIV-1 infection.

"We are excited to collaborate with our colleagues in this important multi-institution research team to help advance gene editing approaches with our novel targeted antibody drug conjugate (ADC) conditioning platform to one day be able to cure patients living with HIV," said John Davis Jr., M.D., M.P.H., M.S., Head of Research & Development and Chief Medical Officer, Magenta. "These studies leverage our proprietary stem cell biology pipeline and ADC platform to provide important insights into which conditioning strategy is best suited to aim for HIV."

Story continues

Magenta will utilize its conditioning technology to optimize cell dose in animal models and determine whether targeted conditioning and gene-modified HSPC transplant enables disease control.

About Magenta Therapeutics

Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with autoimmune diseases, genetic diseases and blood cancers. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant world to revolutionize immune reset for more patients.

Magenta is based in Cambridge, Mass. For more information, please visit http://www.magentatx.com.

Follow Magenta on Twitter: @magentatx.

Forward-Looking Statement

This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation risks set forth under the caption "Risk Factors" in Magentas Annual Report on Form 10-K filed on March 3, 2020, as updated by Magentas most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Magenta believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Magenta nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200902005248/en/

Contacts

Magenta Therapeutics: Lyndsey Scull, Director, Corporate Communications202-213-7086lscull@magentatx.com

Dan Budwick1ABdan@1abmedia.com

Go here to see the original:
Magenta Therapeutics Named Co-Recipient of Grant from the National Institutes of Health to Explore Use of Novel Targeted Conditioning Agents with Gene...

Read More...

Sterile Filtration Market To Reach USD 8.48 Billion By 2027 | CAGR: 7.7% | Reports And Data – PRNewswire

Friday, August 28th, 2020

NEW YORK, Aug. 27, 2020 /PRNewswire/ --The GlobalSterile Filtration Marketis expected to reach USD 8.48 Billion by 2027, according to a new report by Reports and Data. Sterile filtration finds usage in the removal of contaminants and particulates from fluids comprising media with or without buffers, serum, reagents, biologic or proteinaceous samples, or other types of fluids. Filtration through a pore size of 0.2 m is essential to get a sterile filtrate by filtering particles and germs from fluids (liquids and gases) to prevent them from contaminating the end-products. As per the GMP guidelines and the guidelines by the (FDA), producers are required to perform a filter integrity test at the pre and post-production cycle. The test confirms that the filter is completely functional and that no undesirable components got through it.

Biopharmaceuticals products normally cannot be terminally sterilized, and thus it is crucial to use sterile grade filters in aseptic processing. Application of heat sterilization or any other process in biopharmaceutical drug products results in unwanted degradation of the product. Sterilizing membrane filtration frequently necessitated reducing the levels of bioburden within process streams to prevent the potential formation of biofilm. Further, to ascertain that the sterile filtered products uphold the pure form, a growing number of firms, especially the firms in the pharmaceutical sector, are deploying disposable process solutions to store or process the subsequent filtrate.

Request free sample of this research report at: https://www.reportsanddata.com/sample-enquiry-form/3464

The growing use of sterile filtration in the food & beverage industry, especially in breweries, is playing an instrumental role in driving market growth. Recent researches uphold the use of sterile filtration as the most appropriate method for brewers for controlling microbial hazards. Even though beer is alcoholic, acidic, anaerobic, and comprises hop compounds that ply the role of preservatives, certain microorganisms can survive in the chemical environment and thrive on rich nutrients present in beer. These kinds of microorganisms may result in beer spoilage forming a haze or sedimentation, a rancid/sour flavor, and over-carbonation, thus requiring the need for sterile filtration.

COVID-19 Impact Analysis

As global economies are experiencing the negative impact of the Covid-19 pandemic, organizations are suffering losses, among various other challenges. Nevertheless, firms in the pharmaceutical industry are of immense importance in combatting the pandemic and are witnessing positive growth in the contagious disease landscape with the race for treatment approval therapy gaining momentum.

Biopharmaceutical companies are playing a significant role in human response to the COVID-19 pandemic. Various leading biotech companies are studying the genome to prepare a feasible vaccine for its treatment. Growing investments in R&D activities for making the vaccine are fuelling the growth of the sterile filtration market.

To identify the key trends in the industry, click on the link below: https://www.reportsanddata.com/report-detail/sterile-filtration-market

Further key findings from the report suggest

Order Now: https://www.reportsanddata.com/checkout-form/3464

For the purpose of this report, Reports and Data has segmented the Global Sterile Filtration Market on the basis of type, membrane type, application, end-user, and region:

TypeOutlook (Revenue, USD Million; 2017-2027)

Membrane TypeOutlook (Revenue, USD Million; 2017-2027)

ApplicationOutlook (Revenue, USD Million; 2017-2027)

End-UserOutlook (Revenue, USD Million; 2017-2027)

Regional Outlook (Revenue, USD Million;2017-2027)

Have a Look at Similar Research Reports:

Laboratory Filtration Market- Filtration is a technique that is used to separate solids from liquids or solution by interposing a filter medium through which solutions or liquids can pass.

Virus Filtration Market - increasing emphasis and growing investment in R&D activities in the biotechnology sector, there has been an elevated demand for virus filtration.

Gene Expression Market - Gene expression is the method that refers to the process of measuring the activity of genes in order to comprehend the cellular functions.

In vivo CRO Market - Shifting of preference of pharmaceutical industries toward the outsourcing clinical and preclinical trials to focus on their core business, increasing frequency of outsourcing R&D activities.

Protein Engineering Market- Protein engineering is an emerging field that involves synthesis of new proteins as well as amendment in the existing protein structures that ultimately helps to achieve desired functions.

3D Cell Culture Market- The growth is mainly contributed by the government and non-government investments for cancer research & development, coupled with large scale end users for stem cell research.

About Reports and Data

Reports and Data is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target and analyze consumer behavior shifts across demographics, across industries and help client's make a smarter business decision. We offer market intelligence studies ensuring relevant and fact-based research across a multiple industries including Healthcare, Technology, Chemicals, Power and Energy. We consistently update our research offerings to ensure our clients are aware about the latest trends existent in the market. Reports and Data has a strong base of experienced analysts from varied areas of expertise.

Contact Us:John WHead of Business DevelopmentReports And Data | Web: http://www.reportsanddata.com Direct Line: +1-212-710-1370 E-mail: [emailprotected] LinkedIn | Twitter | Blogs

Read full Press Release at :https://www.reportsanddata.com/press-release/global-sterile-filtration-market

SOURCE Reports And Data

See the article here:
Sterile Filtration Market To Reach USD 8.48 Billion By 2027 | CAGR: 7.7% | Reports And Data - PRNewswire

Read More...

Burger Reviews BTK Inhibitors and Beyond in Frontline CLL – Targeted Oncology

Friday, August 28th, 2020

During a virtual Case Based Peer Perspectives event, Jan A. Burger, MD, PhD, professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston, TX, discussed testing and the treatment options for chronic lymphocytic leukemia (CLL), based on the a case of 71-year-old female patient.

Targeted OncologyTM: What testing would you order to confirm diagnosis if you saw this patient in the clinic?

BURGER: We need to establish the diagnosis by flow cytometry and then we would do, at a minimum, FISH cytogenetics and, ideally, the mutational status. Cytogenetics can change, butmutational status usually doesnt change. If thats been established somewhere outside [of your clinic], then you dont have to repeat that test.

Its important to repeat cytogenetics if you talk about the relapse setting. But here, were treating in the frontline setting, and she was tested. She was found to be IGHV unmutated and [positivefor] del(11q). That, traditionally, has been regarded as a higher-risk disease status because these patients respond OK to standard chemotherapy, but they have short remissions and survival times with FCR [fludarabine, cyclophosphamide, and rituximab (Rituxan)], BR [bendamustine plus rituximab], and those kinds of regimens compared with low-risk patients, such as those [who are positive for] deletion 13q and have IGHV mutated disease.

In terms of these sequences, when you see a patient with lymphocytosis, you send for flow cytometry, and part of the flow cytometry panel can test for additional markers, CD38 and ZAP-70. We have it [at MD Anderson], but Im not sure if there are any outside routine flow cytometry labs reporting CD38 positivity or negativity or ZAP-70. These markers used to be very popular 10years or so ago when IGHV-mutation status was not so commonly done and was more complicated to get. Nowadays, theres a shift with sending a sample directly for IGHV-mutation testing.

If you have that and the routine CLL FISH panel, then you have a good amount of information about your patient to say this is high-, low-, or an intermediate-risk disease. I think the main purpose for doing these is, first, to identify [patients with] high-risk disease who have a deletion 17p [del(17p)] or TP53 mutations. If its a young patient, you want to know that to [be able to] avoid chemotherapy. If its a young patient, [you may want to] send those patients for evaluation for stem cell transplant. For some patients, that is still something that eventually needs to be considered for those with del(17p).

What systemic therapy would you offer?

If you have treated with ibrutinib [Imbruvica] and youre comfortable with that, I dont think at this time there is a strong reason to change. In selected patients, it might be reasonable to tryswitching them from one [agent] to the other. But right now, for this patient, consensus says a BTK [Bruton tyrosine kinase] inhibitor is a good treatment.

Both ibrutinib and acalabrutinib [Calquence] can be used as single agents or in combination with CD20 antibodies. Weve done a clinical study with ibrutinib where patients were randomized to receive monotherapy versus a combination with rituximab, and the outcome was virtually identicalwhere patients had the exact same progression-free survival [PFS] with a single agentversus the combination with a CD20 antibody.1

CD20 antibodies with BTK inhibitors dont seem to add benefit in terms of survival if you go with the long-term BTK inhibitor treatment and if youre not planning to stop your treatment atsome point. What they do is they get patients into remission faster and you clear the disease faster if you add a CD20 antibody, but then you stop after 6 months. You continue your BTKinhibitor, and patients do great 2, 3, and 4 years later. Then, you dont see any effect in terms of longer-term PFS or overall survival [OS] from the addition of the CD20 antibody.

What data support the use of single-agent ibrutinib in patients with untreated CLL?

There are data from the RESONATE-2 study [NCT01722487], which randomized patients between ibrutinib and chlorambucil. This study was designed at the time when chlorambucil monotherapy was still the standard of care. Patients were randomized 1:1, and patients with del(17p) were excluded.2

What is nice about this study is that we have a long follow-up now.3 At the 5-year follow-up, you see this major difference in terms of PFS [HR, 0.146; 95% CI, 0.098-0.218]. There is also anoverall survival benefit [HR, 0.450; 95% CI, 0.266-0.761].

What [we saw was] that patients with del(11q) seemed to have a better PFS than those patients who lack del(11q) when they are treated with ibrutinib. Patients with del(11q) who are treated with chemotherapy do not do as well as those who lack this cytogenetic abnormality. The same is true here for [IGHV] mutational status.

The PCYC-1102-CA study [NCT01105247] opened around 2010, and we now have 7 to 8 years of follow-up. If you use a BTK inhibitor in the frontline setting, you can expect that most patients are going to do well for an extended period of time. At 5, 6, and 7 years or longer, 70% to 80% of patients are still in remission and have not died.4

Another randomized study that created some waves [is the E1912 study (NCT02048813)]. Weve been big proponents of FCR, which was the comparator arm [of this trial] versus ibrutinib. Patients receive either 6 cycles FCR or continuous ibrutinib [with rituximab] for the first 6 cycles.5

That study showed that compared with FCR, there was a significant increase in PFS [HR, 0.39; 95% CI, 0.26-0.57; P <.0001] but also in OS benefit from the BTK inhibitorcontaining regimen[HR, 0.34; 95% CI, 0.15-0.79; P = .009].

Would you say ibrutinib is the standard of care for treatment of CLL in the frontline setting?

Ibrutinib monotherapy, I would say, is the standard of care, but ibrutinib plus rituximab can be used. Some of you use it and, based on the data we just saw, the FDA has now officiallyapproved it.6 It doesnt mean you must use rituximab.

What other ibrutinib combinations are available?

The ALLIANCE trial [NCT01886872] had a single-agent ibrutinib arm versus ibrutinib plus rituximab versus bendamustine plus rituximab.7 When you have patients randomized to receive ibrutinib/rituximab versus ibrutinib as a single agent, the [Kaplan-Meier survival] curves are basically identical, and thats what we got as well in a slightly diff erent patient population, mostlyrelapsed patients. In terms of PFS, rituximab doesnt seem to add very much when you go with continuous ibrutinib treatment. You see the difference for bendamustine/rituximab, with whichpatients have significantly shorter PFS.

I think the theme is the same over and over again with these randomized studies. With the new targeted agents, such as the BTK inhibitors and venetoclax [Venclexta], we see the samepattern. The new agents are doing better than our traditional chemoimmunotherapy.

ILLUMINATE [NCT02264574] is the study comparing ibrutinib/obinutuzumab [Gazyva] with another chemoimmunotherapy regimen, which has been somewhat popular for older populations, more frail patients for whom you dont want to use FCR or BR. You traditionally use chlorambucil alone and then more recentlyits combined with CD20 antibodies. The patients were randomized to either [ibrutinib/obinutuzumab] versus chlorambucil/obinutuzumab treatment.8

The results show a major PFS benefits for patients on the BTK inhibitor [HR, 0.23; 95% CI, 0.15-0.37; P < .0001]. There was a big difference for genetically high-risk patients [HR, 0.15; P <.0001] or patients who had bulky disease.

What other BTK inhibitors would you consider here?

Now were going to the second-generation BTK inhibitor, acalabrutinib [Calquence], which is somewhat more selective and doesnt inhibit some other kinases that ibrutinib does. Its a newBTK inhibitor with not as much long-term follow-up data available.

[In the phase 3 ELEVATE TN trial (NCT02475681)], you have 3 arms: single-agent acalabrutinib, acalabrutinib combined with obinutuzumab, and the comparator arm of chlorambucil/obinutuzumab. 9 If you give that to treatment-nave patients, those receiving BTK inhibitor alone or with the CD20 antibody do well. Its debatable if the PFS difference is significant, but clearly, the BTK inhibitortreated patients do much better than those receivingchlorambucil plus obinutuzumab.

[If you look at the] subgroups of patients benefitting from the BTK inhibitor treatment versus obinutuzumab/chlorambucil, it basically shows that all subgroups have benefit. Some may be alittle more than others...but I think particularly patients that we traditionally called high risk are the ones who benefit the most from new agents. Theres less difference if you go into the lowriskpatient populations.

Are there data supporting the use of a BCL2 inhibition?

The other frontline option involves venetoclax, and thats coming from this CLL14 trial [NCT02242942]. Patients were receiving venetoclax/obinutuzumab or chlorambucil/obinutuzumab, and this is a finite treatment for 12 months. These are patients who were older and who have some comorbidities. Deletion(17p) was not excluded.10

There is a major difference in PFS favoring the new targeted agent venetoclax. Now its approved for the frontline treatment of selected patients,11 but you can also see in comparison to theBTK inhibitors [that] the follow-up is relatively short of 3 years.

With venetoclax, you get more complete remissions and some of these remissions are MRD [minimal residual disease] negative. As long as these differences are not translating into a survival benefit, those are just numbers.

Would you recommend venetoclax after the first line?

I dont think theres a reason to make that change [from BTK inhibitors] because venetoclax has its own issues in terms of how its used and adverse effects [AEs]. For that questionmaybe [we ask [is] venetoclax better in terms of outcome than a BTK inhibitor?

Its difficult to be better than the BTK inhibitor in the frontline CLL setting, and you need a very long follow-up to show any differences if there are any.

A substantial number of patients [treated with venetoclax] receive MRD-negative remissions with this combination. MRD negativity doesnt mean patients are cured. There is drop off in PFS, so MRD negativity doesnt mean those patients will survive and never need treatment again. Most likely, those patients eventually will lose MRD and eventually have disease progression and need treatment again. I think for those studies based on frontline venetoclax for 12 months, we just have to stay tuned and wait for what the long-term outcome is going to be.

What are the AEs of venetoclax?

You see more AEs that are reminiscent of chemotherapy days, where patients get more cytopenia. Its well established that venetoclax is myelosuppressive. Certainly, neutropenia can be seen, and less frequently, thrombocytopenia and anemia. If you treat a patient with venetoclax with or without a CD20 antibody, then you have to prepare for some patients having issueswith neutropenia and some who cannot be fully dose-escalated because of those cytopenias.

If the patient was younger, would you treat differently?

My answer would be no. I dont see any difference. This patient was 71 years old. We wouldnt use chemoimmunotherapy.

Somebody voted no. I think thats interesting because its something Im interested in [finding out about]. Im wondering if we have to accept treating patients with BTK inhibitorsfor very long periods or if we can maybe try it at least as an alternative treatment just for a certain period of time until we have the best response. Then, some patients maybe stop. I think thats interesting for a clinical trial.

Outside of clinical trials, Im not so sure. We have no data. But if you have a low-risk patient and you want to stop after 2 years and just see what happens, you need to tell the patient we dontknow whats going to happen and you have to watch that patient more closely. If its a patient with del(17p), a high-risk patient who was very symptomatic, I wouldnt do that. But in low-risk patients, I think its an interesting question and not totally unreasonable.

Over time, we will find new solutions. Everybodys working on transitioning BTK inhibitorsto limited-duration treatments for many reasons. Its not the optimal situation to have patients onkinase inhibitors for 5, 10, or 20 years. Right now, its a long-term treatment until we have better treatments.

References:

1. Burger JA, Sivina M, Jain N, et al. Randomized trial of ibrutinib vs ibrutinib plus rituximab in patients with chronic lymphocytic leukemia. Blood. 2019;133(10):1011-1019. doi:10.1182/blood-2018-10-879429

2. Burger JA, Tedeschi A, Barr PM, et al. Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. N Engl J Med. 2015;373(25):2425-2437. doi:10.1056/NEJMoa1509388

3. Burger JA, Barr PM, Robak T, et al. Long-term effi cacy and safety of fi rst-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study. Leukemia. 2020;34(3):787-798. doi:10.1038/s41375-019-0602-x

4. Byrd JC, Furman RR, Coutre SE, et al. Ibrutinib treatment for fi rst-line and relapsed/ refractory chronic lymphocytic leukemia: fi nal analysis of the pivotal phase Ib/II PCYC- 1102 study. Clin Cancer Res. Published online March 24, 2020. doi:10.1158/1078-0432.CCR-19-2856

5. Shanafelt TD, Wang XV, Kay NE, et al. Ibrutinib and rituximab provides superior clinical outcome compared to FCR in younger patients with chronic lymphocytic leukemia (CLL): extended follow-up from the E1912 Trial. Blood. 2019;134(suppl 1):33. doi:10.1182/blood-2019-126824

6. FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia. News release. FDA. April 21, 2020. Accessed July 27, 2020. https://bit.ly/3jV1hGW

7. Woyach JA, Ruppert AS, Heerema NA, et al. Ibrutinib regimens versus chemoimmunotherapy in older patients with untreated CLL. N Engl J Med. 2018;379(26):2517-2528. doi:10.1056/NEJMoa1812836

8. Moreno C, Greil R, Demirkan F, et al. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in fi rst-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019;20(1):43-56. Published correction appears in Lancet Oncol. 2019;20(1):e10.doi:10.1016/S1470-2045(18)30788-5

9. Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial. Lancet. 2020;395(10232):1278-1291. Published correction appears in Lancet. 2020;395(10238):1694. doi:10.1016/S0140-6736(20)30262-2

10. Fischer K, Al-Sawaf O, Bahlo J, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380(23):2225-2236. doi:10.1056/NEJMoa1815281

11. FDA approves venetoclax for CLL and SLL. News release. FDA. May 15, 2019.Accessed July 27, 2020. https://bit.ly/3jLnEOU

Read this article:
Burger Reviews BTK Inhibitors and Beyond in Frontline CLL - Targeted Oncology

Read More...

CytoDyn Reaches Enrollment of 195 Patients in its Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms – GlobeNewswire

Friday, August 28th, 2020

Interim analysis to commence after 28 days; results anticipated by mid-October

VANCOUVER, Washington, Aug. 25, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Company has reached the requisite number of enrolled patients in its Phase 3 trial for COVID-19 patients with severe-to-critical symptoms to perform an interim analysis following the 28-day phase of the trial.

This Phase 3 trial is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab in patients with severe-to-critical symptoms of respiratory illness caused by COVID-19. Patients are randomized to receive weekly doses of 700 mg leronlimab or placebo, administered via weekly subcutaneous injection for two weeks. The study has three phases lasting 28 days: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. Recently, the Data Safety Monitoring Committee (DSMC) completed its first safety review of patients in the Phase 3 trial and reported it saw no cause to modify the study. The DSMC reviewed safety data from 149 of the 169 patients enrolled at the time of their review. The DSMC did not raise any concerns regarding safety and recommended the trial continue as planned.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We are very thankful for the many clinicians and their staff who have worked tirelessly to advance enrollment this quickly and for their care of these seriously ill patients. We are eager to perform an interim analysis of the data and remain optimistic the interim results will be consistent with those experienced by patients who received leronlimab through multiple EINDs (over 60) previously authorized by the FDA. And, in the event we are successful, we are well positioned with our distribution partner to accelerate distribution of leronlimab to patients throughout the U.S.

About Coronavirus Disease 2019CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. Enrollment continues in its Phase 3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 is believed to typically transmit person-to-person through respiratory droplets. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140)The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA has agreed to provide written responses to the Companys questions concerning its recent Biologics License Application by September 4, 2020, in lieu of a Type A teleconference meeting for this HIV combination therapy.

CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Michael MulhollandOffice: 360.980.8524, ext. 102Mobile: 503.341.3514mmulholland@cytodyn.com

Continue reading here:
CytoDyn Reaches Enrollment of 195 Patients in its Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms - GlobeNewswire

Read More...

Tiger Woods, Rory McIlroy and more — This isn’t the best time for some of the PGA Tour’s biggest names – ESPN

Friday, August 28th, 2020

NORTON, Mass. - What the first week of the FedEx Cup playoffs revealed was it is not the best time to be one of the biggest names in golf.

With the exception of Dustin Johnson, the runaway winner at The Northern Trust, the first event of the PGA Tour's FedEx Cup playoffs, some of the sport's brightest stars have looked a bit lost.

Sure, Tiger Woods closed with a 66, including a four-birdie run to start his final round, but all it did was mask three uneven days that had him in a spot he never wants to be in -- playing early in the morning on the weekend of a tournament as nothing more than an afterthought.

Rory McIlroy, who played poorly enough to be Woods' early morning playing partner on the weekend, had no other choice but to make a joke or two about his own mediocrity lately when it was all over. More telling was that he feels at times he is simply going through the motions.

Brooks Koepka didn't even make it to the first tee, withdrawing before the event began because his bad knee isn't getting any better.

Jordan Spieth and Phil Mickelson didn't make the cut, placing them outside the top 70, which is required to gain entry into next week's BMW Championship, the second stop of the FedEx Cup playoffs.

He admitted Sunday that life without fans has been a difficult adjustment. He has always fed off the energy of the galleries that engulfed him -- and used it as an advantage over opponents who were shell-shocked by all the people and all the commotion.

But the silence seems to be a secondary problem for Woods. The inconsistency in his game remains the central issue. At The Northern Trust, he struggled at times with his putting; during Saturday's ugly 2-over 73, he missed six putts inside 10 feet. Until Sunday, he was again off with his short irons, regularly leaving lengthy birdie putts instead of medium-to-short range opportunities. His average distance from the hole on approach was just under 37 feet, which doesn't provide a ton of realistic birdie chances.

"Every day is different," he said. "That's golf. Shot-to-shot is different. That's the ebb and flow of playing golf."

He has played three events since golf's return from a three-month shutdown because of the coronavirus pandemic. He was a non-factor at both the Memorial and PGA Championship, finished tied for 37th and 40th. This week, at the Northern Trust, he had a strong opening round, then faded on Friday and Saturday. He's committed to this week's BMW Championship but hasn't earned a spot in the season-ending Tour Championship. And in this new, condensed schedule, the U.S. Open, the year's second major, is lurking right around the corner, set to begin Sept. 17 at ultra-difficult Winged Foot.

"This is going to be a long haul," he said.

Sure, the state of McIlroy's game is unsettling.

"If you need anyone to shoot even to 2-under for a week, I'm your man," he joked after finishing the week at, you guessed it, 2 under. "That's sort of what I've done the last few weeks. Everything is just a little off."

More concerning than his game might be his mindset.

"This is going to sound really bad, but I feel like the last few weeks, I've just been going through the motions," he said. "I want to get an intensity and some sort of fire, but I just haven't been able to. And look, that's partly to do with the atmosphere and partly to do with how I'm playing. I'm not inspiring myself, and I'm trying to get inspiration from outside sources to get something going."

On Saturday, with Woods, he started his round birdie/triple bogey/birdie. As he walked to the fourth tee he chuckled, "Yeah, 3-8-2 is a good area code." He was asked, in this time of playing tournaments without crowds and largely in silence, what the difference is now between a birdie and triple bogey?

"Honestly, not that much," he admitted. "It's not that much. Sometimes I come off a green and make a birdie, and I'm sort of -- you know, you're sort of laughing coming off a hole that you've just messed up, and you make a birdie, and it's sort of almost a more negative emotion in some ways. It's weird. It's very strange."

With two more playoff events and two more majors still on the 2020 calendar, how does he fix it?

"Do you go on YouTube and look at past successes do you give yourself something to sort of think about, a mantra as you go around?" he wondered. "There's different ways to do it. You know, what's always sort of done well with me is a bet or a game or a play for something. That sometimes gets something out of me. Maybe that's the strategy. I do that in practice rounds sometimes with [caddie and close friend] Harry [Diamond]. We make a lot of bets, and I try to shoot scores and try to win dinner or whatever it is. Maybe that's it. We're playing in the FedEx Cup [playoffs]. There's a lot of incentive here to play well. It's just trying to get it out of you."

McIlroy was on a roll before golf stopped in March. In the six events he played before the sport started at the Players Championship, McIlroy had not finished worse than a tie for fifth, and that included a win at the WCG-HSBC Champions. Since the return, has just one top-30 finish, a tie for 11th at the Travelers Championship.

"Yeah, it's just been a bit of a struggle," he said.

On Friday, as his round and season concluded, Jordan Spieth walked quickly off the 18th green at TPC Boston, never picking his head up as he headed toward the clubhouse. He had missed his second cut in six events, this one following a T-71 finish at the PGA Championship and a T-72 at the Wyndham Championship. He's had just one top-20 since a T-10 at the Charles Schwab Challenge, the first event after the break.

I'm a little uncertain. Like it feels pretty good, not great, but good enough to be able to compete," he said after the Wyndham Championship.

The missed cut at The Northern Trust meant he would not qualify for next week's BMW Championship, marking the first time in his career he did not advance to the second stage of the FedEx Cup playoffs. He hasn't made it to the season-ending Tour Championship since 2017. He hasn't won an event since the 2017 Open at Royal Birkdale, a stretch of 69 events.

"I'll keep trucking, I'll keep working hard," he said.

As long as his knee is up to it, the next time we'll see Koepka is at the U.S. Open, where he will try to win that major for the third time in four years. It's been an up-and-down year for the four-time major winner, who had a stem cell procedure on his left knee after last year's Tour Championship then re-aggravated when he slipped during an event in South Korea in October, which required him to sit out until January.

Since then, he's had just two top-10s, missed four cuts and had to withdraw from two events, one because of injury, one because his caddie, Ricky Elliott, tested positive for COVID-19.

Earlier this month, in search of his third consecutive PGA Championship, he entered the final round tied for fourth, just 2 shots off the lead. He faded on Sunday, shooting 74 to tie for 29th. The next week he missed the cut at the Wyndham Championship.

"Brooks is one of the biggest names in the game. We've all seen his physical struggles since last year," McIlroy said earlier this week. "It's maybe never a good time, but it's a better time than any other time to get it right. Take a few weeks off, try to get himself ready for the U.S. Open, and then the Masters coming up [in November]. I think it's smart on his part to do that and hopefully comes back healthy and comes back ready to play."

Like Spieth, Mickelson missed the cut and didn't qualify for the BMW Championship. So to get some work in before returning to what the site of one of his most painful major championship disappointments -- Winged Foot, site of this year's U.S. Open -- he needed to find a place to play.

Enter the PGA Tour Champions, the over-50 circuit that has an event this week in the Ozarks.

"I've been playing well and I want to play," he said. "I wish I was playing in Chicago next week but excited to play my first Champions event."

Mickelson, who turned 50 in June, has one top-20 finish and two missed cuts since golf's return. He had been reluctant to head over to the Champions Tour, making it clear he thinks he can still play -- and win -- on the PGA Tour.

"When I stop hitting bombs, I'll play the Champions Tour, but I'm hitting some crazy bombs right now," he joked in January.

Read more from the original source:
Tiger Woods, Rory McIlroy and more -- This isn't the best time for some of the PGA Tour's biggest names - ESPN

Read More...

G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer – GlobeNewswire

Saturday, August 22nd, 2020

- PDUFA action date of February 15, 2021 assigned by U.S. Food and Drug Administration- Priority Review for trilaciclib is based on positive data from three randomized clinical trials showing robust myelopreservation benefits- G1 launching expanded access program (EAP) for patients with small cell lung cancer in the U.S.

RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) patients being treated with chemotherapy and granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2021. Trilaciclib is a first-in-class investigational therapy designed to preserve bone marrow and immune system function during chemotherapy and improve patient outcomes.

There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur, said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. If approved, trilaciclib would be the first proactively administered myelopreservation therapy that is intended to make chemotherapy safer and reduce the need for rescue interventions, such as growth factor administrations and blood transfusions.

The FDA grants Priority Review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.The trilaciclib NDA was supported by compelling myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy treatment in patients with SCLC. Trilaciclibhas been granted Breakthrough Therapy Designation by the FDA.In the NDA acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting to discuss this application.

While undergoing chemotherapy, many patients experience significant myelosuppression, become fatigued and susceptible to infection, and often require transfusions and growth factor administrations, said Jared Weiss, M.D., Lineberger Comprehensive Cancer Center,University of North Carolina Chapel Hill, NC. Preventing bone marrow damage proactively is an opportunity to improve the quality of life of patients receiving chemotherapy for small cell lung cancer and reduce costly rescue interventions.

Myelosuppression is the result of damage to bone marrow stem cells and is one of the most common side effects of chemotherapy. Myelosuppression can lead to serious conditions such as anemia, neutropenia or thrombocytopenia, which have broad ranging clinical, patient experience and economic impacts on ongoing cancer treatment and overall outcomes. In clinical trials, trilaciclib significantly reduced chemotherapy-induced myelosuppression, and patients receiving trilaciclib experienced fewer dose delays/reductions, infections, hospitalizations, and need for rescue therapies compared to patients receiving chemotherapy alone.

Expanded Access ProgramG1 is making trilaciclib available to SCLC patients in the U.S., who are unable to enter clinical trials and for whom there are no appropriate alternative treatments while the trilaciclib NDA is under regulatory review, pursuant to FDAs expanded access program (EAP). To facilitate needed access through the EAP, G1 is collaborating with Bionical Emas, a global specialist clinical research organization (CRO). For more information about the EAP access to trilaciclib, email patient.access.us@Bionical-emas.com.

Complications from myelosuppression have been a long-standing challenge when treating patients with SCLC, said Dr. Malik. Establishing an expanded access program provides qualified patients in serious need with access to trilaciclib while the NDA is under review.

Trilaciclib in Small Cell Lung CancerTrilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. In 2019, trilaciclib received FDA Breakthrough Therapy Designation, and, in June 2020, G1 submitted the NDA based on myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy in patients with small cell lung cancer (SCLC). In August 2020, G1 received FDA Priority Review with the Prescription Drug User Fee Act (PDUFA) date of February 15, 2021.

In June 2020, G1 announced a co-promotion agreement with Boehringer Ingelheim for trilaciclib in small cell lung cancer in the U.S. and Puerto Rico. If approved, G1 will lead marketing, market access and medical engagement initiatives for trilaciclib. The Boehringer Ingelheim oncology commercial team, well-established in lung cancer, will lead sales force engagement initiatives.G1 will book revenue and retain development and commercialization rights to trilaciclib and pay Boehringer Ingelheim a promotional fee based on net sales. The three-year agreement does not extend to additional indications that G1 is evaluating for trilaciclib. Press release details of the G1/ Boehringer Ingelheim agreement can be found here.

Evaluating Trilaciclib in Other CancersIn a randomized trial of women with metastatic triple-negative breast cancer, preliminary data showed that trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. The company plans to present final overall survival data from this trial in the fourth quarter of 2020. Trilaciclib is being evaluated in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL, and the company expects to initiate a Phase 3 trial in patients treated with chemotherapy for colorectal cancer in the fourth quarter of 2020.

About G1 TherapeuticsG1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of next generation therapies that improve the lives of those affected by cancer. The company is developing and advancing two novel therapies: trilaciclib is a first-in-class therapy designed to improve outcomes for patients being treated with chemotherapy; rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. In 2020, the company out-licensed global development and commercialization rights to its differentiated oral CDK4/6 inhibitor, lerociclib.

G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit http://www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the U.S. and Europe for trilaciclib in SCLC, trilaciclibs possibility to improve patient outcomes across multiple indications, rintodestrants potential to be best-in-class oral SERD, lerociclibs differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors, our reliance on partners to develop and commercial licensed products, and the impact of pandemics such as COVID-19 (coronavirus), are based on the companys expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the companys actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the companys filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the companys ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the companys initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts:Investors:Jeff MacdonaldG1 Therapeutics, Inc.Senior Director, Investor Relations & Corporate Communications919-907-1944jmacdonald@g1therapeutics.comMedia:Christine RogersG1 Therapeutics, Inc.Associate Director, Corporate Communications984-365-2819crogers@g1therapeutics.com

Go here to see the original:
G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer - GlobeNewswire

Read More...

CytoDyn Will Attempt to Duplicate Berlin and London Patients’ HIV Cure by Using Leronlimab During Bone Marrow Transplant for 5 HIV Patients Who also…

Tuesday, August 18th, 2020

HIV monotherapy trials update: 215 patients completed almost one year of monotherapy. Only some were allowed to continue in extension arm; five patients reached almost 6 years. Twenty-five reached 2 to 4 years and 20 patients are 1 to 2 years

VANCOUVER, Washington, Aug. 17, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company gives full update on all of its HIV programs.

HIV CureThe HIV co-receptor CCR5 has proven to be a key molecule in mediating HIV remission. The only two individuals functionally cured of HIV, one from London and the other from Berlin, received allogeneic stem cell transplantations from CCR5-deficient donors. However, because it is extremely rare to find a stem cell donor who lacks CCR5 and meets stringent MHC matching criteria, such an approach is unfeasible to cure HIV on a larger scale. CytoDyn believes its CCR5 blocking antibody, leronlimab, could be used in the setting of allogeneic stem cell transplantation to functionally convert a stem cell graft from a wildtype CCR5 stem cell donor into one from a CCR5 deficient donor, and thereby functionally cure the recipient of HIV.

CytoDyn plans to test this theory in a pilot clinical trial of five HIV patients with cancer who require bone marrow transplantation. Leronlimab will be used during the peri-transplant period to mimic a CCR5 deficient donor in order to achieve HIV cure.

HIV PrEPAs presented at the AIDS 2020 Virtual Conference, a pre-clinical study in the macaque model of HIV sexual transmission demonstrated leronlimab can prevent infection by blocking HIVs access to the CCR5 co-receptor. This protection is similar to that seen in individuals naturally CCR5 deficient and forms the rationale for use in HIV cure. CytoDyn believes leronlimab could be a once-a-month self-injectable, subcutaneous treatment for HIV PrEP and is in discussions with potential organizations to fund its next trial in HIV PrEP.

MonotherapySignificantly, for the first time documented, of the 49 HIV patients who stopped their HIV medications and used leronlimab as a monotherapy, 25 have been in monotherapy trial for two to four years and five patients for nearly or over six years. Monotherapy was successful for some of these patients by switching from 350 mg to a higher dose of 525 mg or 700 mg. The number of participants in the extension groups was limited due to costs.

The Company will submit manuscripts for two publications in regards to its findings.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We now have four paths forward for use of leronlimab in the HIV indication for different populations. The first path is a combination therapy where we successfully completed a Phase 3 trial with statistically significant p value for our primary endpoint. CytoDyn is awaiting a Type A meeting with the FDA for this treatment. Second is our monotherapy; we will discuss the potential approval path for label expansion at the time of our Type A meeting. Third is our PrEP study to examine the use of leronlimab for once-a-month self-injection for HIV prevention. Our fourth path is an HIV-Cure, where 5 patients will be put to test to duplicate the Berlin and London patients HIV functional cure.

About Leronlimab (PRO 140)The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.

The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The Company has requested a Type A meeting with the FDA to discuss the FDAs request for additional information in order to resubmit its Biologics License Application for this HIV combination therapy.

CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors:Michael MulhollandOffice: 360.980.8524, ext. 102Mobile: 503.341.3514mmulholland@cytodyn.com

More here:
CytoDyn Will Attempt to Duplicate Berlin and London Patients' HIV Cure by Using Leronlimab During Bone Marrow Transplant for 5 HIV Patients Who also...

Read More...

What do we need to know about our bone health during this pandemic – Times of India

Tuesday, August 18th, 2020

As the on-going COVID-19 pandemic continues we are facing a huge healthcare crisis. Globally the pandemic has accelerated or rather decelerated the entire human population into the confines. Work from home, social shielding and discreet outdoor ventures has not only disrupted our emotional well-being but has also drastically affected our physical health. As people are confined to their homes with reduced physical activity there is rapid bone resorption (loss) as muscles and bones are not getting adequate stimulation. Also lack of exposure to sun during the pandemic has critically affected vitamin D levels in our body. People are frequently feeling tired with lack of energy and strength. Everyone needs to be cautious about the health of their bones as much as their other needs. Bones support us and allow us to be mobile. Bone health is always a priority and we always tend to overlook it. Bone density problem is a silent manifestation and could lead to a major medical issue over a period of time. While osteoporosis onsets with age among men & women, women face the brunt a little earlier, like from their 30s. Well-versed with the situation and to avoid unnecessary bones issues, let us now take a look at some measures that can take care of your bones during the pandemic.Eat a well-balanced diet rich in calcium and vitamin DGood sources of calcium include low-fat dairy products, green leafy veggies and dry fruits. Good sources of vitamin D include fortified cereals, egg yolks, saltwater fish, liver and milk. Calcium and vitamin D work together to protect your bones - calcium helps to build and maintain bones; while vitamin D helps your body to effectively absorb calcium.

Get exposure to sunlight to make enough vitamin DRegular sun exposure is the most natural way to get enough vitamin D. The sun's ultraviolet B (UVB) rays hit cholesterol in the skin cells, providing the energy for vitamin D synthesis. Vitamin D has a significant role in calcium homeostasis and metabolism.

As per pan-India study the best time to get exposed to the sun is between 11 am and 1 pm since the wavelength of ultraviolet B (UVB) rays is 290-320nm during this period which is essential for skin to make vitamin D.

Get plenty of physical activityLike muscles, bones become stronger with exercise. The best exercises for healthy bones are strength-building and weight-bearing exercise like walking, climbing stairs, lifting weights and dancing. Try to get 30 minutes of exercise each day.

Strength-building and weight-bearing exercise provides stimulation to bone cells and helps to increased bone mineral density and bone size thus reduced the risk of osteoporosis.

Live a healthy lifestyle

See the rest here:
What do we need to know about our bone health during this pandemic - Times of India

Read More...

Cellect Biotechnology Ltd ADR (NASDAQ:APOP) Receives an Approval of a Pivotal Patent for Stem Cells Activation from the European Patent Office – BP…

Saturday, August 15th, 2020

Every successful medicinal activity requires mass production of quality stem cells. This is what avails regenerative medicine to the public the need occasioned the founding of Cellect Biotechnology Ltd ADR (NASDAQ:APOP). In 2011. The companys vision was to bring to reality regenerative treatments, which would accelerate the production of stem cell-based treatments.

Cellect has spent 15 years in research, thanks to its ApoGraft methodology, which is long-sought-after because it engages an inexpensive process. This is what has birthed seven families of patents. The company just received a pivotal patent for Stem Cells Activation from the European Patent Office. This patent, which will expire on October 7, 2034, is the most significant event for the company seeking to strengthen its Intellectual Property (IP) portfolio.

Over the past few years, the need to strengthen its IP has been a core component of the companys business strategy. According to the CEO Dr. Shai Yarkoni, they wanted to tap into the clinical and economic benefits, which come with the patent. The primary benefit and, as the company has demonstrated previously, is the increased safety and efficacy of the cell product. This is enhanced by the development of a robust and user-friendly process.

While the extensive issued patents cover the accurate elimination (negative selection) of the mature cells and therefor enables SAFETY, this patent covers the increased ACTIVITY (positive selection=efficacy) of the regenerative capacity of the stem and progenitor cells Yarkoni explained.

Cellect Biotechnology has 65 patents in nine patent families. Out of these, 45 of them have been allowed patent, 18 are waiting for examination while the remaining two are the Patent Cooperation Treaty (PCT) applications. The Biotech aim is to expand and protect global IP. This will provide researchers and clinical community tools to isolate stem cells in quantity and quality rapidly. The final results will automatically be a wide variety of applications in regenerative medicine.

Meanwhile, the company has also been consulting and discussing widely with global leaders. Before long, it will be able to take control of innovation in the development of cell therapies.

See the original post:
Cellect Biotechnology Ltd ADR (NASDAQ:APOP) Receives an Approval of a Pivotal Patent for Stem Cells Activation from the European Patent Office - BP...

Read More...

Coronavirus Drug and Treatment Tracker – The New York Times

Saturday, August 15th, 2020

The Covid-19 pandemic is one of the greatest challenges modern medicine has ever faced. Doctors and scientists are scrambling to find treatments and drugs that can save the lives of infected people and perhaps even prevent them from getting sick in the first place.

Below is an updated list of 20 of the most-talked-about treatments for the coronavirus. While some are accumulating evidence that theyre effective, most are still at early stages of research. We also included a warning about a few that are just bunk.

We are following 20 coronavirus treatments for effectiveness and safety:

Tentative or

mixed evidence

We are following 20 coronavirus treatments

for effectiveness and safety:

Tentative or

mixed evidence

We are following 20 coronavirus treatments

for effectiveness and safety:

There is no cure yet for Covid-19. And even the most promising treatments to date only help certain groups of patients and await validation from further trials. The F.D.A. has not fully licensed any treatment specifically for the coronavirus. Although it has granted emergency use authorization to some treatments, their effectiveness against Covid-19 has yet to be demonstrated in large-scale, randomized clinical trials.

This list provides a snapshot of the latest research on the coronavirus, but does not constitute medical endorsements. Always consult your doctor about treatments for Covid-19.

New additions and recent updates:

Added ivermectin, a drug typically used against parasitic worms that is being increasingly prescribed in Latin America. Aug. 10

Updated descriptions for several treatments. Aug. 10

We will update and expand the list as new evidence emerges. For details on evaluating treatments, see the N.I.H. Covid-19 Treatment Guidelines. For the current status of vaccine development, see our Coronavirus Vaccine Tracker.

WIDELY USED: These treatments have been used widely by doctors and nurses to treat patients hospitalized for diseases that affect the respiratory system, including Covid-19.

PROMISING EVIDENCE: Early evidence from studies on patients suggests effectiveness, but more research is needed. This category includes treatments that have shown improvements in morbidity, mortality and recovery in at least one randomized controlled trial, in which some people get a treatment and others get a placebo.

TENTATIVE OR MIXED EVIDENCE: Some treatments show promising results in cells or animals, which need to be confirmed in people. Others have yielded encouraging results in retrospective studies in humans, which look at existing datasets rather than starting a new trial. Some treatments have produced different results in different experiments, raising the need for larger, more rigorously designed studies to clear up the confusion.

NOT PROMISING: Early evidence suggests that these treatments do not work.

PSEUDOSCIENCE OR FRAUD: These are not treatments that researchers have ever considered using for Covid-19. Experts have warned against trying them, because they do not help against the disease and can instead be dangerous. Some people have even been arrested for their false promises of a Covid-19 cure.

EVIDENCE IN CELLS, ANIMALS or HUMANS: These labels indicate where the evidence for a treatment comes from. Researchers often start out with experiments on cells and then move onto animals. Many of those animal experiments often fail; if they dont, researchers may consider moving on to research on humans, such as retrospective studies or randomized clinical trials. In some cases, scientists are testing out treatments that were developed for other diseases, allowing them to move directly to human trials for Covid-19.

All treatmentsWidely usedPromisingTentative or mixedNot promisingPseudoscience

Antivirals can stop viruses such as H.I.V. and hepatitis C from hijacking our cells. Scientists are searching for antivirals that work against the new coronavirus.

PROMISING EVIDENCE EVIDENCE IN CELLS, ANIMALS AND HUMANSEMERGENCY USE AUTHORIZATIONRemdesivirRemdesivir, made by Gilead Sciences, was the first drug to get emergency authorization from the F.D.A. for use on Covid-19. It stops viruses from replicating by inserting itself into new viral genes. Remdesivir was originally tested as an antiviral against Ebola and Hepatitis C, only to deliver lackluster results. But preliminary data from trials that began this spring suggested the drug can reduce the recovery time of people hospitalized with Covid-19 from 15 to 11 days. (The study defined recovery as either discharge from the hospital or hospitalization for infection-control purposes only.) These early results did not show any effect on mortality, though retrospective data released in July hints that the drug might reduce death rates among those who are very ill.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS, ANIMALS AND HUMANSFavipiravirOriginally designed to beat back influenza, favipiravir blocks a viruss ability to copy its genetic material. A small study in March indicated the drug might help purge the coronavirus from the airway, but results from larger, well-designed clinical trials are still pending.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS, ANIMALS AND HUMANSMK-4482Another antiviral originally designed to fight the flu, MK-4482 (previously known as EIDD-2801) has had promising results against the new coronavirus in studies in cells and on animals. Merck, which has been running clinical trials on the drug this summer, has announced it will launch a large Phase III trial in September.Updated Aug. 6

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS Recombinant ACE-2To enter cells, the coronavirus must first unlock them a feat it accomplishes by latching onto a human protein called ACE-2. Scientists have created artificial ACE-2 proteins which might be able to act as decoys, luring the coronavirus away from vulnerable cells. Recombinant ACE-2 proteins have shown promising results in experiments on cells, but not yet in animals or people.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS AND HUMANS IvermectinFor decades, ivermectin has served as a potent drug to treat parasitic worms. Doctors use it against river blindness and other diseases, while veterinarians give dogs a different formulation to cure heartworm. Studies on cells have suggested ivermectin might also kill viruses. But scientists have yet to find evidence in animal studies or human trials that it can treat viral diseases. As a result, Ivermectin is not approved to use as an antiviral.

In April, Australian researchers reported that the drug blocked coronaviruses in cell cultures, but they used a dosage that was so high it might have dangerous side effects in people. The FDA immediately issued a warning against taking pet medications to treat or prevent Covid-19. These animal drugs can cause serious harm in people, the agency warned.

Since then a number of clinical trials have been launched to see if a safe dose of ivermectin can fight Covid-19. In Singapore, for example, the National University Hospital is running a 5,000-person trial to see if it can prevent people from getting infected. As of now, theres no firm evidence that it works. Nevertheless ivermectin is being prescribed increasingly often in Latin America, much to the distress of disease experts.Updated Aug. 10

NOT PROMISING EVIDENCE IN CELLS AND HUMANS Lopinavir and ritonavirTwenty years ago, the F.D.A. approved this combination of drugs to treat H.I.V. Recently, researchers tried them out on the new coronavirus and found that they stopped the virus from replicating. But clinical trials in patients proved disappointing. In early July, the World Health Organization suspended trials on patients hospitalized for Covid-19. They didnt rule out studies to see if the drugs could help patients not sick enough to be hospitalized, or to prevent people exposed to the new coronavirus from falling ill. The drug could also still have a role to play in certain combination treatments.

NOT PROMISING EVIDENCE IN CELLS, ANIMALS AND HUMANSHydroxychloroquine and chloroquineGerman chemists synthesized chloroquine in the 1930s as a drug against malaria. A less toxic version, called hydroxychloroquine, was invented in 1946, and later was approved for other diseases such as lupus and rheumatoid arthritis. At the start of the Covid-19 pandemic, researchers discovered that both drugs could stop the coronavirus from replicating in cells.

Since then, theyve had a tumultuous ride. A few small studies on patients offered some hope that hydroxychloroquine could treat Covid-19. The World Health Organization launched a randomized clinical trial in March to see if it was indeed safe and effective for Covid-19, as did Novartis and a number of universities. Meanwhile, President Trump repeatedly promoted hydroxychloroquine at press conferences, touting it as a game changer, and even took it himself. The F.D.A. temporarily granted hydroxychloroquine emergency authorization for use in Covid-19 patients which a whistleblower later claimed was the result of political pressure. In the wake of the drugs newfound publicity, demand spiked, resulting in shortages for people who rely on hydroxychloroquine as a treatment for other diseases.

But more detailed studies proved disappointing. A study on monkeys found that hydroxychloroquine didnt prevent the animals from getting infected and didnt clear the virus once they got sick. Randomized clinical trials found that hydroxychloroquine didnt help people with Covid-19 get better or prevent healthy people from contracting the coronavirus. Another randomized clinical trial found that giving hydroxychloroquine to people right after being diagnosed with Covid-19 didnt reduce the severity of their disease. (One large-scale study that concluded the drug was harmful as well was later retracted.) The World Health Organization, the National Institutes of Health and Novartis have since halted trials investigating hydroxychloroquine as a treatment for Covid-19, and the F.D.A. revoked its emergency approval. The F.D.A. now warns that the drug can cause a host of serious side effects to the heart and other organs when used to treat Covid-19.

In July, researchers at Henry Ford hospital in Detroit published a study finding that hydroxychloroquine was associated with a reduction in mortality in Covid-19 patients. President Trump praised the study on Twitter, but experts raised doubts about it. The study was not a randomized controlled trial, in which some people got a placebo instead of hydroxychloroquine. The studys results might not be due to the drug killing the virus. Instead, doctors may have given the drug to people who were less sick, and thus more likely to recover anyway.

Despite negative results, a number of hydroxychloroquine trials have continued, although most are small, testing a few dozen or a few hundred patients. A recent analysis by STAT and Applied XL found more than 180 ongoing clinical trials testing hydroxychloroquine or chloroquine, for treating or preventing Covid-19. Although its clear the drugs are no panacea, its theoretically possible they could provide some benefit in combination with other treatments, or when given in early stages of the disease. Only well-designed trials can determine if thats the case.Updated Aug. 10

Most people who get Covid-19 successfully fight off the virus with a strong immune response. Drugs might help people who cant mount an adequate defense.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS AND HUMANS Convalescent plasmaA century ago, doctors filtered plasma from the blood of recovered flu patients. So-called convalescent plasma, rich with antibodies, helped people sick with flu fight their illness. Now researchers are trying out this strategy on Covid-19. In May, the F.D.A. designated convalescent plasma an investigational product. That means that despite not yet being shown as safe and effective, plasma can be used in clinical trials and given to some patients who are seriously ill with Covid-19. Tens of thousands of patients in the U.S. have received plasma through a program launched by the Mayo Clinic and the federal government.

The Trump administration has praised convalescent plasma, despite the lack of evidence yet that it works. The first wave of trials have been small and the results have been mixed. Large randomized clinical trials are underway, but theyve struggled to enroll enough participants, some of whom worry they will receive a placebo instead of the treatment itself.

Experts say that its vital to complete these trials to determine if convalescent plasma is safe and effective. If these trials are successful, it could serve as an important stopgap measure until more potent therapies become widely available.Updated Aug. 10

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS, ANIMALS AND HUMANSMonoclonal antibodiesConvalescent plasma from people who recover from Covid-19 contains a mix of different antibodies. Some of the molecules can attack the coronavirus, but many are directed at other pathogens. Researchers have sifted through this slurry to find the most potent antibodies against Covid-19. They have then manufactured synthetic copies of these molecules, known as monoclonal antibodies. Researchers have begun investigating them as a treatment for Covid-19, either individually or in cocktails.

Monoclonal antibodies were first developed as a therapy in the 1970s, and since then the F.D.A. has approved them for 79 diseases, ranging from cancer to AIDS. Since the start of the pandemic, researchers have found dozens of monoclonal antibodies that show promise against Covid-19 in preclinical studies on cells and animals. Companies like Eli Lilly and Regeneron recently began clinical trials studying monoclonal antibodies. Several other firms, as well as teams at universities, are slated to enter the race soon as well.Updated Aug. 10

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN CELLS, ANIMALS AND HUMANSInterferonsInterferons are molecules our cells naturally produce in response to viruses. They have profound effects on the immune system, rousing it to attack the invaders, while also reining it in to avoid damaging the bodys own tissues. Injecting synthetic interferons is now a standard treatment for a number of immune disorders. Rebif, for example, is prescribed for multiple sclerosis.

As part of its strategy to attack our bodies, the coronavirus appears to tamp down interferon. That finding has encouraged researchers to see whether a boost of interferon might help people weather Covid-19, particularly early in infection. Early studies, including experiments in cells and mice, have yielded encouraging results that have led to clinical trials.

An open-label study in China suggested that the molecules could help prevent healthy people from getting infected. On July 20, the British pharmaceutical company Synairgen announced that an inhaled form of interferon called SNG001 lowered the risk of severe Covid-19 in infected patients in a small clinical trial. The full data have not yet been released to the public, or published in a scientific journal. On August 6, the National Institute of Allergy and Infectious Diseases launched a Phase III trial on a combination of Rebif and the antiviral remdesivir, with results expected by fall 2020.Updated Aug. 10

The most severe symptoms of Covid-19 are the result of the immune systems overreaction to the virus. Scientists are testing drugs that can rein in its attack.

PROMISING EVIDENCE EVIDENCE IN HUMANS DexamethasoneThis cheap and widely available steroid blunts many types of immune responses. Doctors have long used it to treat allergies, asthma and inflammation. In June, it became the first drug shown to reduce Covid-19 deaths. That study of more than 6,000 people, which in July was published in the New England Journal of Medicine, found that dexamethasone reduced deaths by one-third in patients on ventilators, and by one-fifth in patients on oxygen. It may be less likely to help and may even harm patients who are at an earlier stage of Covid-19 infections, however. In its Covid-19 treatment guidelines, the National Institutes of Health recommends only using dexamethasone in patients with COVID-19 who are on a ventilator or are receiving supplemental oxygen.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN HUMANS Cytokine InhibitorsThe body produces signaling molecules called cytokines to fight off diseases. But manufactured in excess, cytokines can trigger the immune system to wildly overreact to infections, in a process sometimes called a cytokine storm. Researchers have created a number of drugs to halt cytokine storms, and they have proven effective against arthritis and other inflammatory disorders. Some turn off the supply of molecules that launch the production of the cytokines themselves. Others block the receptors on immune cells to which cytokines would normally bind. A few block the cellular messages they send. Depending on how the drugs are formulated, they can block one cytokine at a time, or muffle signals from several at once.

Against the coronavirus, several of these drugs have offered modest help in some trials, but faltered in others. Drug companies Regeneron and Roche drug both recently announced that two drugs called sarilumab and tocilizumab, which both target the cytokine IL-6, did not appear to benefit patients in Phase 3 clinical trials. Many other trials remain underway, several of which combine cytokine inhibitors with other treatments.Updated Aug. 10

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN HUMANS EMERGENCY USE AUTHORIZATIONBlood filtration systemsThe F.D.A. has granted emergency use authorization to several devices that filter cytokines from the blood in an attempt to cool cytokine storms. One machine, called Cytosorb, can reportedly purify a patients entire blood supply about 70 times in a 24-hour period. A small study in March suggested that Cytosorb had helped dozens of severely ill Covid-19 patients in Europe and China, but it was not a randomized clinical trial that could conclusively demonstrate it was effective. A number of studies on blood filtration systems are underway, but experts caution that these devices carry some risks. For example, such filters could remove beneficial components of blood as well, such as vitamins or medications.Updated Aug. 10

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN HUMANS Stem cellsCertain kinds of stem cells can secrete anti-inflammatory molecules. Over the years, researchers have tried to use them as a treatment for cytokine storms, and now dozens of clinical trials are under way to see if they can help patients with Covid-19. But these stem cell treatments havent worked well in the past, and its not clear yet if theyll work against the coronavirus.

Doctors and nurses often administer other supportive treatments to help patients with Covid-19.

WIDELY USEDProne positioningThe simple act of flipping Covid-19 patients onto their bellies opens up the lungs. The maneuver has become commonplace in hospitals around the world since the start of the pandemic. It might help some individuals avoid the need for ventilators entirely. The treatments benefits continue to be tested in a range of clinical trials.

WIDELY USEDEMERGENCY USE AUTHORIZATIONVentilators and other respiratory support devicesDevices that help people breathe are an essential tool in the fight against deadly respiratory illnesses. Some patients do well if they get an extra supply of oxygen through the nose or via a mask connected to an oxygen machine. Patients in severe respiratory distress may need to have a ventilator breathe for them until their lungs heal. Doctors are divided about how long to treat patients with noninvasive oxygen before deciding whether or not they need a ventilator. Not all Covid-19 patients who go on ventilators survive, but the devices are thought to be lifesaving in many cases.

TENTATIVE OR MIXED EVIDENCE EVIDENCE IN HUMANS AnticoagulantsThe coronavirus can invade cells in the lining of blood vessels, leading to tiny clots that can cause strokes and other serious harm. Anticoagulants are commonly used for other conditions, such as heart disease, to slow the formation of clots, and doctors sometimes use them on patients with Covid-19 who have clots. Many clinical trials teasing out this relationship are now underway. Some of these trials are looking at whether giving anticoagulants before any sign of clotting is beneficial.

False claims about Covid-19 cures abound. The F.D.A. maintains a list of more than 80 fraudulent Covid-19 products, and the W.H.O. debunks many myths about the disease.

WARNING: DO NOT DO THISDrinking or injecting bleach and disinfectantsIn April, President Trump suggested that disinfectants such as alcohol or bleach might be effective against the coronavirus if directly injected into the body. His comments were immediately refuted by health professionals and researchers around the world as well as the makers of Lysol and Clorox. Ingesting disinfectant would not only be ineffective against the virus, but also hazardous possibly even deadly. In July, Federal prosecutors charged four Florida men with marketing bleach as a cure for COVID-19.

WARNING: NO EVIDENCEUV lightPresident Trump also speculated about hitting the body with ultraviolet or just very powerful light. Researchers have used UV light to sterilize surfaces, including killing viruses, in carefully managed laboratories. But UV light would not be able to purge the virus from within a sick persons body. This kind of radiation can also damage the skin. Most skin cancers are a result of exposure to the UV rays naturally present in sunlight.

WARNING: NO EVIDENCESilverThe F.D.A. has threatened legal action against a host of people claiming silver-based products are safe and effective against Covid-19 including televangelist Jim Bakker and InfoWars host Alex Jones. Several metals do have natural antimicrobial properties. But products made from them have not been shown to prevent or treat the coronavirus.

Note: After additional discussions with experts we have adjusted several labels on the tracker. The Strong evidence label has been removed until further research identifies treatments that consistently benefit groups of patients infected by the coronavirus. In its place, Promising evidence will be used for drugs such as remdesivir and dexamethasone that have shown promise in at least one randomized controlled trial, and Widely used for treatments such as proning and ventilators that are often used with severely ill patients, including those with Covid-19. And we may reintroduce the Ineffective label when ongoing clinical trials repeatedly end with disappointing results.

Sources: National Library of Medicine; National Institutes of Health; William Amarquaye, University of South Florida; Paul Bieniasz, Rockefeller University; Jeremy Faust, Brigham & Womens Hospital; Matt Frieman, University of Maryland School of Medicine; Noah Haber, Stanford University; Swapnil Hiremath, University of Ottawa; Akiko Iwasaki, Yale University; Paul Knoepfler, University of California, Davis; Elena Massarotti, Brigham and Womens Hospital; John Moore and Douglas Nixon, Weill Cornell Medical College; Erica Ollman Saphire, La Jolla Institute for Immunology; Regina Rabinovich, Harvard T.H. Chan School of Public Health; Ilan Schwartz, University of Alberta; Phyllis Tien, University of California, San Francisco.

See the original post here:
Coronavirus Drug and Treatment Tracker - The New York Times

Read More...

Page 6«..5678..20..»


2024 © StemCell Therapy is proudly powered by WordPress
Entries (RSS) Comments (RSS) | Violinesth by Patrick