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Collaborative Review of Scientific Evidence Announced By FDA – JD Supra

March 10th, 2020 7:45 pm

Updated: May 25, 2018:

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Collaborative Review of Scientific Evidence Announced By FDA - JD Supra

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New UNC computational tool boosts understanding of genetic disorders affecting the brain – WRAL Tech Wire

March 10th, 2020 7:45 pm

CHAPEL HILL Scientists at the UNC School of Medicine and colleagues created a new computational tool called H-MAGMA to study the genetic underpinnings of nine brain disorders, including the identification of new genes associated with each disorder.

The research,published inNature Neuroscience, revealed that genes associated with psychiatric disorders are typically expressed early in life, highlighting the likelihood of this early period of life as critical in the development of psychiatric illnesses. The researchers also discovered that neurodegenerative disorder-associated genes are expressed later in life. Lastly, the scientists linked these disorder-associated genes to specific brain cell types.

By using H-MAGMA, we were able to link non-coding variants to their target genes, a challenge that had previously limited scientists ability to derive biologically meaningful hypotheses from genome-wide association studies of brain disorders, said study senior authorHyejung Won, PhD, assistant professor of genetics at the UNC School of Medicine and member of the UNC Neuroscience Center. Additionally, we uncovered important biology underlying the genetics of brain disorders, and we think these molecular mechanisms could serve as potential targets for treatment.

Hyejung Won, PhD UNC photo)

Brain disorders such as schizophrenia and Alzheimers disease are among the most burdensome disorders worldwide. But there are few treatment options, largely due to our limited understanding of their genetics and neurobiological mechanisms. Genome-wide association studies (GWAS) have revolutionized our understanding of the genetic architecture related to many health conditions, including brain-related disorders. GWAS is a technique that allows researchers to compare genetic sequences of individuals with a particular trait such as a disorder to control subjects. Researchers do this by analyzing the genetic sequences of thousands of people.

To date, we know of hundreds of genomic regions associated with a persons risk of developing a disorder, Won said. However, understanding how those genetic variants impact health remained a challenge because the majority of the variants are located in regions of the genome that do not make proteins. They are called non-coding genetic variants. Thus, their specific roles have not been clearly defined.

Prior research suggested that while non-coding variants might not directly encode proteins, they can interact with and regulate gene expression. That is, these variants help regulate how genes create proteins, even though these variants do not directly lead to or code for the creation of proteins.

Given the importance of non-coding variants, and that they make up a large proportion of GWAS findings, we sought to link them to the genes they interact with, using a map of chromatin interaction in the human brain, Won said. Chromatin is the tightly packed structure of DNA and proteins inside cells, folded in the nucleus in a way to maintain normal human health.

Won and colleagues used this map to identify genes and biological principles underlying nine different brain disorders, including psychiatric conditions such as schizophrenia, autism, depression, and bipolar disorder; and neurodegenerative disorders such as Alzheimers, Parkinsons, amyotrophic lateral sclerosis (ALS), and multiple sclerosis (MS).

Using the computational tool H-MAGMA, Won and colleagues could link non-coding variants to their interacting genes the genes already implicated in previous GWAS findings.

Another important question in brain disorders is to identify cellular etiology the cells involved in the root cause of disease. This is especially critical as the brain is a complex organ with many different cell types that may act differently in response to treatment. In the attempt of finding critical cell types for each brain disorder, the researchers found that genes associated with psychiatric disorders are highly expressed in glutamatergic neurons, whereas genes associated with neurodegenerative disorders are highly expressed in glia, further demonstrating how the two disorder clusters diverge from each other.

Moreover, we classified biological processes central to the disorders, Won said. From this analysis, we found that the generation of new brain cells, transcriptional regulation, and immune response as being essential to many brain disorders.

Won and colleagues also generated a list of shared genes across psychiatric disorders to describe common biological principles that link psychiatric disorders.

Amongst the shared genes, we once again identified the brains early developmental process as being critical and upper layer neurons as being the fundamental cell-types involved, Won said We unveiled the molecular mechanism that underscores how one gene can affect two or more psychiatric diseases.

H-MAGMA is publicly available so that the tool can be widely applicable and available to the genetics and neuroscience community to help expand research, with the ultimate goal of helping people who suffer with brain-related conditions.

The National Institute of Mental Health, the Brain and Behavior Research Foundation, and the Simons Foundation Autism Research Initiative funded this research.

Other authors were Nancy Sey, Benxia Hu, Won Mah, Harper Fauni, Jessica McAfee, all from UNC-Chapel Hill, and Prashanth Rajarajan, Kristen Brennand, and Schahram Akbarian from Mount Sinai Health System.

(C) UNC-Chapel Hill

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Invitae to Acquire YouScript and Genelex to Make it Easier to Use Pharmacogenetic Information at the Point of Care – PRNewswire

March 10th, 2020 7:45 pm

SAN FRANCISCO, March 10, 2020 /PRNewswire/ --Invitae Corporation(NYSE: NVTA), a leading medical genetics company, today announced it has entered into definitive agreements to acquire YouScript, a privately held clinical decision support and analytics platform, and Genelex, a privately held pharmacogenetic testing company, to bring best-in-class pharmacogenetic testing, and robust, integrated clinical decision support to Invitae. Pharmacogenetic testing evaluates genetic variations that can impact how an individual responds to prescription medication.

"Adding pharmacogenetics to Invitae's services enables us to offer greater value to our existing customers and helps us expand into new customer types and clinical areas," said Sean George, co-founder and chief executive officer of Invitae. "Despite its broad utility, the incorporation of pharmacogenetic information into routine medical care has been slow. We believe that Invitae's business model and technological capabilities, combined with an offering designed for ease of use in supporting clinical care, can accelerate the use of pharmacogenetic information. This is an exciting next step in our mission to bring comprehensive genetic information into mainstream medical care."

Pharmacogenetic variants with medical implications are very common. For example, a cross-sectional study of more than 7.7 million U.S. veterans published in 2019 found that 99% of individuals in the Veteran Health Administration system carry at least one actionable pharmacogenetic variant. Furthermore, over half of the individuals had been prescribed a drug for which deciding to use the drug or determining the proper dosage would be affected by relevant pharmacogenetic information.1 Routine pharmacogenetic testing can provide clinicians with information to improve treatment and reduce the possibility of adverse events, particularly for patients with complex medication regimens or co-existing conditions.

"Pharmacogenetic information becomes clinically actionable when the complex web of multifactor interactions, including drug-drug and drug-gene, is used to characterize risk and benefit," said Robert Nussbaum, M.D., chief medical officer of Invitae. "Simply detecting pharmacogenetic variation is not nearly enough to make the information clinically useful. Combining Genelex testing with clinical decision support in the EMR using YouScript software enables clinicians to easily navigate this information when making prescription choices at the point of care."

YouScript offers an innovative clinical decision support tool for healthcare providers that can assist in patient medication management at the point of care. The software pairs a patient's pharmacogenetic profile with published drug and gene interaction information to assess the risk for adverse drug events and possible side effects. Clinicians receive information, alerts, and possible medication alternatives in real-time through a clear and concise interactive interface to help optimize medication choice to improve patient care. YouScript is integrated with major electronic medical record (EMR) systems, including Epic, Cerner, and Allscripts.

In addition to providing clinical support at the patient level, health systems can use YouScript at population scale to identify patient populations at highest risk for adverse events. The software identifies those patients who are most likely to benefit from pharmacogenetic testing based on their drug regimen. The utilization of YouScript's software, in combination with Genelex pharmacogenetic testing, has been shown to reduce adverse events, costs and hospital readmissions in peer-reviewed published studies.

"Our clinical decision support tool is focused on giving clinicians the most comprehensive, evidence-based information in an actionable, easy-to-use format. This enables the safest, most informed decision for their patient in real time, within the workflow," said Kristine Ashcraft, chief executive officer of YouScript. "Joining forces with Genelex and Invitae will allow us to help a larger number of clinicians use genetics not just for the few but as a routine practice for all their patients."

Genelex offers pharmacogenetic testing that analyzes the genes that are important for understanding variation in how people metabolize and respond differently to prescription medications. The testing process includes pharmacist review, patient- and clinician-facing reports, as well as access to clinical decision support for the treating provider.

"Accelerating the use of genetic information to inform treatment choices is essential for realizing the power of genetics in mainstream medicine," said Chris Howlett, chief executive officer of Genelex."The combination of Genelex's expertise in pharmacogenetics, YouScript's advanced clinical decision support and Invitae's expertise in delivering genetic information that is affordable and accessible at scale enables us to help more clinicians and their patients benefit from genetics-informed treatment choice."

Under the definitive agreements, Invitae will acquire YouScript for approximately $79.3 million, subject to certain adjustments, consisting of $25 million in cash and the remaining in Invitae common stock (based upon a trailing average trading price as of the agreement date), and Invitae will acquire Genelex for approximately $20.7 million in upfront shares of Invitae common stock (based upon a trailing average trading price as of the agreement date) plus additional shares of Invitae common stock in the event that certain milestones are achieved. The acquisitions are expected to close in the coming weeks, pending customary closing conditions. The acquisitions are not expected to materially change previously shared guidance on revenue and volume for 2020.

Conference Call and Webcast Details

Management will host a conference call and webcast today at 2:00 p.m. Pacific / 5:00 p.m. Eastern to discuss the acquisitions. The dial-in numbers for the conference call are (866) 393-4306 for domestic callers and (734) 385-2616 for international callers, and the reservation number for both is 4663118. Following prepared remarks, management will respond to questions from investors and analysts, subject to time limitations.

The live webcast of the call and slide deck may be accessed by visiting the investors section of the company's website atir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company's website.

About InvitaeInvitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website at invitae.com.

About YouScriptYouScript enables faster, more proactive personalized medication management to reduce avoidable adverse drug events. YouScript is a trusted partner to value-based healthcare organizations, providers, and payers who want to bend the healthcare cost curve with the power of precision medicine. Partners include Clover Health, Group Health of South-Central Wisconsin, Highmark BCBS, and TELUS Health. YouScript's technology synthesizes the evidence impacting drug response, including pharmacogenetic testing, to support doctors and pharmacists at the point of care. YouScript is the only clinically validated system that shows improved outcomes, reduced costs and high patient and provider satisfaction. YouScript is successfully integrated into the clinical workflow of Epic, Cerner, Allscripts, GraneRx and other leading healthcare technology providers. For more information about YouScript, please visit:www.youscript.com.

YouScript has not been reviewed or approved by the United States Food and Drug Administration and cannot be used to diagnose or treat any disease or other health condition.

About GenelexGenelex is one of the longest-standing laboratories in the United States, specializing in pharmacogenetics testing and was one of the first clinical laboratories to provide pharmacogenetic testing and interpretation as the creator of the patented, proprietary and powerful YouScript Personalized Prescribing System. Genelex pharmacogenetic tests reveal natural variations that determine how the body processes commonly prescribed medications.

Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits of the proposed acquisitions; the expected timing of the closing of the proposed acquisitions; the capabilities and benefits of YouScript and/or Genelex technology; the company's ability to integrate and expand the use of YouScript and/or Genelex technology and the impact thereof; and the company's business strategy, and its beliefs regarding the ways in which the proposed acquisitions will contribute to that strategy. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the parties' ability to satisfy the conditions precedent to the consummation of the proposed transactions, including the parties' ability to close the proposed acquisitions; the occurrence of any event that could give rise to the termination of one or both acquisition agreements; unanticipated difficulties or expenditures relating to the proposed transactions; the risk that expected benefits of the proposed transactions may not be achieved in a timely manner, or at all; the risk that the YouScript and/or Genelex technology may not be efficiently or successfully integrated into, or otherwise scale with, the company's platform; the company's history of losses; the company's ability to compete; the company's ability to manage growth effectively; the company's ability to use rapidly changing genetic data and technology to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company's business; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Annual Report on Form 10-K for the year ended December 31 , 2019. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

Source: Invitae Corporation

Contact:Laura D'Angelo[emailprotected](628) 213-3283

SOURCE Invitae Corporation

http://invitae.com

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Invitae to Acquire YouScript and Genelex to Make it Easier to Use Pharmacogenetic Information at the Point of Care - PRNewswire

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Removing the Barriers to Broad Adoption of NGS in Diagnostics – Technology Networks

March 10th, 2020 7:45 pm

Credit: Online Marketing on Unsplash.

When it comes to applying genomic sequencing in diagnostic medicine, increasing evidence is demonstrating that whole exome sequencing (WES) can sometimes fall short. This is a particular issue when analyzing large segments of DNA from patients and can adversely impact a physician's diagnosis.An alternative to WES is the utilization of a smaller, more targeted genetic test that analyzes a specific panel of genes known to be associated with a certain pathology. These tests are less of a financial burden on healthcare systems and patients and can offer highly accurate results. Targeted NGS is enabling this testing approach, and we're seeing increased adoption of NGS in the clinical diagnostics space.

But what barriers still exist to the full implementation of NGS, and how can we remove them? Technology Networks recently spoke with Luca Quagliata, Ph.D., Global Director of Medical Affairs for Thermo Fisher Scientific, to learn more.Molly Campbell (MC): How is genome sequencing currently utilized in the oncology diagnostics space? What are its limitations?Luca Quagliata (LQ): Sequencing of DNA and RNA is currently used in routine molecular testing for two purposes. Firstly, they are used with the aim of supporting a diagnostic decision, i.e. differential diagnosis (such as PIDGFA mutation status in gastrointestinal stromal cancer. More commonly, they are adopted to complement a pathology report by adding information related to a clinically relevant genomic variant (e.g. mutations in the EGFR gene) that are directly associated with any specific approved drug treatment (for example, BRAF inhibitors for V600E BRAF mutated melanoma patients).Some of the major limitations of genomic testing are related to quality of the starting material for testing (generally known as pre-analytic issues, e.g. tissue fixation), the ability of a given sequencing method to generate usable results (not every sequencing approach is born equal), the capability of interpreting the results (e.g. is the observed genomic variant a pathogenic alteration or is simply benign?) and finally the economic aspect. Who should pay for the test?MC: Why does WES commonly fail to adequately analyze large segments of DNA?LQ: As above mentioned, not all sequencing methods are born equal, WES can be performed using a variety of library preparation kits, possibly leading to substantially different results.1 Unfortunately, no universally accepted standard has been established for WES, especially for oncology applications.Generally, one of the most common issue is related to the sequencing depth, also known as coverage. High coverage allows to gain higher confidence in the generated results, as the genomic examined regions are analyzed multiple times, thus increasing the robustness of the data. However, high coverage comes at the cost of increasing sequencing price. Plus, even in the absence of any financial constraints, increasing coverage indefinitely is simply not possible due to technical limitations, i.e. the input material will define the maximal reachable coverage.

Furthermore, it is well established that, in certain situations, even pushing the coverage a 100-fold higher does not generate any tangible benefit in terms of data analysis output. Finally, a variety of alignment and calling algorithms can be deployed to identify large DNA segments rearrangements. Once again, no standard is strictly defined, thus the varying ability of different algorithms will greatly impact the final result. To conclude, while robust approaches are in place for single nucleotide variants (SNV) or multiple nucleotide variants (MNP), as well as insertions and deletions (INDEL), this is not the case when applying WES to study large DNA segments. Nowadays, microarray-based investigations are very popular for assessment of large genomic rearrangements.MC: Why is a targeted test more suitable in the diagnostics space?LQ: Targeted NGS is most commonly used for routine diagnostics because:

MC: NGS is becoming increasingly easier for patients to access and costs are rapidly declining. In your opinion, will we reach a stage where a genetic test is as common as, say, having a blood test when you visit your healthcare provider?LQ: While the price of NGS, meaning reagents related costs to perform the test, is undoubtedly going down, one should not forget that the largest fraction of NGS cost is generated by the human labor necessary to carry out the analysis. Thus, any technological approach that will reduce human intervention in the process will be the most effective in compressing the overall sequencing cost to enable true democratization of NGS.At Thermo Fisher Scientific, we recently made a significant step in this direction with the launch of the Ion Torrent Genexus System, the first research NGS solution that automates the entire specimen to report workflow in a single day with only two touch points.Having said that, there is no doubt that sequencing will eventually become as common as performing a classical blood check. The question is, rather, when will it happen?

In my opinion, that will largely depend not exclusively on the reduction of the overall NGS cost, but rather our ability to expand our understanding of the genomic variants clinical implications. As for now, only a limited fraction of variants can be clearly classified and associated with either a clinical condition or a drug treatment benefit. In my view, it is rather a matter of knowledge than merely a problem of costs. We use blood testing not only because it is easy and cheap, but because we can generate valuable and meaningful information through it.MC: The number of individuals undergoing direct-to-consumer genetic testing at home is on the rise. In your opinion, what impact is this having on the use of genetic testing in the clinical spaceLQ: Direct-to-consumer (DTC) genetic testing is an interesting recent phenomenon that in my view poses several questions, mainly regarding the quality of the results it provides. Several regulatory agencies have expressed concerns and are now acting with the aim of monitoring this market. In this initial and still immature phase of DTC, I strongly advocate for the implementation of a regulatory framework that should be considered not a barrier to wide genomic testing access but rather a safeguard.Should that framework be implemented, then DTC market expansion will have a positive effect on the use of genetic testing in the clinical space, as an audience of genetic-educated patients will also inevitably push physicians toward the adoption of genomics in medicine.

Should the DTC genetic market be given complete freedom, I am concerned that it would negatively impact genetic testing in the clinical space, as people might be easily convinced that managing this kind of data is simplistic, and thus the value of a controlled and professionally regulated testing approach will lose value. I think of this in relation to the "Dr Google self-medication" phenomenon.MC: What challenges still exist in the use of NGS in diagnostics?LQ: Overall NGS data generation and interpretation is still perceived as being extremely complex. Furthermore, while we are witnessing an increase in policy coverage for NGS testing, reimbursement remains a practical issue as well as NGS results being restricted to very specific indications. Finally, limited medical education and awareness regarding the value of genetic testing remains high in the healthcare community, with a substantial knowledge gap between physicians working at large academic centres and those working in the community setting. It will take a shared collective effort to remove the above-mentioned barriers to allow broad adoption of NGS in routine diagnostics. No single company, as large as it could be, can achieve such results.

We at Thermo Fisher Scientific are on the front-line supporting precision medicine through partnering with a variety of major stakeholders in the field, from patient advocacy groups to medical associations and Pharma.

Luca Quagliata, Ph.D., Global Director of Medical Affairs for Thermo Fisher Scientific, was speaking to Molly Campbell, Science Writer, Technology Networks.References:

1. Clinical Exome Studies Have Inconsistent Coverage, Clinical Chemistry, Volume 66, Issue 1, January 2020, Pages 199206.

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Removing the Barriers to Broad Adoption of NGS in Diagnostics - Technology Networks

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Rapid genetic testing becomes available to Calgary medical community – CTV News

March 10th, 2020 7:45 pm

CALGARY -- When Madden Ellis Garraway was just under two-years-old, he became very sick.

His skin was so dry it bled and he couldnt hold down food, causing his weight dropped to within ounces of his birth weight of seven pounds, six ounces.

Doctors struggled to figure out what was wrong.

We had a large list of things that we were thinking of, and our immunology team and my colleagues who are working with Madden were having trouble arriving at the right one," said Dr. Francois Bernier, head of the Department of Medical Genetics and a professor in the Department of Paediatrics at the University of Calgary's Cumming School of Medicine.

"In fact, we made some attempts to arrive at a diagnosis but we're still unsure. It took a while.

Doctors often struggle with diagnosing unusual health issues, especially those that may require genetic testing.

They often must rely on genome sequencing tests to determine the root cause of a disease and until now, large-scale genome sequencing tests were often sent to labs in the United States for analysis.

Bernier calls it "the diagnostic odyssey," a long, difficult, journey for families waiting while cliniciansfigure out what is causing the underlying health issues.

Madden Garraway in hospital at the age of two. (Photo courtesy the Garraway family)

Maddens family can attest to that.

It was months of waiting, wondering and worrying before Madden's blood was sent to a U.S. lab for genome analysis, where it was learned he suffered from a rare genetic condition called immune dysregulation polyendocrinopathy enteropathy X-linked (IPEX) syndrome.

IPEX is a rare genetic disorder that can be life threatening.

"If we could have learned about that instantly, or within the several weeks that we can do now, that will save a lot of time," said Maddens father, Patrick Garraway.

"We could have got on with his bone marrow transplant sooner."

Madden received a bone marrow transplant from his sister. Now five-years-old, the playful youngster has made a full recovery and no longer requires medication.

"There are so many families waiting for answers to serious medical conditions," said Bernier.

"Access to gene sequencing early in the medical journey can pinpoint the best treatment approaches and therapies to target the illness."

Madden Garraway today at the age of five. (Photo courtesy the Garraway family)

A new partnership struck between the University of Calgary, University of Alberta, and Alberta Precision Laboratorieswill help families and medical professionalsanswer to those diagnostic puzzles sooner.

The partnership is funded by Genome Canada, the Alberta Childrens Hospital Foundation, and other partners. Four other centres in Canada are also undertaking similar programs through Genome Canadas funding, one in B.C., two in Ontario and one in Quebec.

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Patients turn to Stanford’s center of excellence for treatment of hereditary hemorrhagic telangiectasia – Stanford Medical Center Report

March 10th, 2020 7:45 pm

Jennifer Cook has dealt with migraine headaches and nosebleeds since she was in junior high school, but it wasnt until much later in life, after two small strokes in her 40s, that she discovered these seemingly disconnected ailments including strange, little red dots on her hands and face were all symptoms of a genetic disorder running rampant through three generations of her family.

We all started to connect the dots, said Cook, 48, of Sacramento, referring to about a decade ago, when her father was the first in the family diagnosed with hereditary hemorrhagic telangiectasia, or HHT, a little-known disorder causing malformed blood vessels that can affect the skin and other organs. Since then, her aunt, sister, two of her brothers and two of her daughters also have been diagnosed.

It was so shocking to find out, said her daughter Nina Murphy-Cook, 23, also of Sacramento, who was diagnosed four years ago. Bloody noses, headaches and strokes in really young people. Literally, we had no idea. We all got those little red spots on the skin. My mom just called them Irish moles and said it was just something our family gets.

Cook and her daughter, now patients at Stanford Health Cares recently designatedHHT Center of Excellence, are under the care of a multidisciplinary team of specialists that includes interventional radiologists, neurosurgeons, pulmonologists, otolaryngologists, hematologists, gastroenterologists and a genetic counselor. The team members diagnose, prevent and, if necessary, treat the disparate problems that can result from this often undiagnosed and misdiagnosed disease.

If people get diagnosed and treated, they can have a normal life expectancy with this disease, said Edda Spiekerkoetter, MD, associate professor of pulmonary and critical care medicine and director of the Stanford HHT center. Otherwise, theyre susceptible to chronic, dangerous illnesses without even knowing there are treatments that can prevent them from happening. Key to solving this problem is better educating the public, including doctors, on how to recognize the symptoms. Shes educating primary care physicians, otolaryngologists and dentists, in particular, to serve as frontline screeners: They can keep an eye out for the hallmark red dots, called teleangiectasia, in the oral cavity and on lips and ask about nosebleeds, which are extremely common in patients.

HHTcauses abnormal connections, called arteriovenous malformations, to develop between arteries and veins. They can cause all sorts of problems. These deformed vessels growmost commonly in the nose, lungs, brain, gut and liver andcan cause brain bleeds, nosebleeds, strokes, gastrointestinal bleeding and heart failure. Themalformationsgrow in place of smaller vessels called capillaries, which normally connect arteries and veins. Capillaries are responsible for oxygen uptake into the blood and filter small particles circulating in the blood. Bypassing the capillary bed, these larger, malformed vessels allow small blood clots, bacteria and air bubbles to circulate throughout the body unfiltered. This can lead to strokes or a reduction of oxygen in the blood, which can lead to shortness of breath and exhaustion.

To prevent complications from these deformed vessels in the lungs, you need an interventional radiologist to step in; to prevent brain bleeds, you need a neurosurgeon;abdominal bleeds and anemia can be controlled by a gastroenterologist and hematologist; andotolaryngologists can help prevent severe nosebleeds, Spiekerkoetter said. While HHT is rare affecting an estimated 1 in 5,000 people 90% of cases go undiagnosed, Spiekerkoetter said. Patients often dont get diagnosed until after a serious event, such as a stroke.

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This is why you always skip the gym, according to scientists – Ladders

March 10th, 2020 7:45 pm

There are plenty of possible choices, but perhaps the most obnoxious type of Instagram selfie is the gym snapshot. In the world of social media, did you really visit the gym if you didnt post about it? These images and their captions usually make exercise seem like a breeze; a daily ritual that the fitness influencers of the world seem to be able to accomplish without the slightest bit of hesitation. For the rest of us, though, visiting the gym can feel like a struggle.

If youve ever felt like an entirely different species than the people who smile their way through 6 AMgym sessions four days per week, a new study finds that may not be as outlandish as it initially sounds. No, those people arent aliens, but researchers from Kings College London have discovered a connection between ones genes and their ability to exercise.

More specifically, theyve found a genetic mutation that appears to seriously hinder an individuals capacity to exercise efficiently. This mutation affects ones cellular oxygen sensing. Basically, this means that people with this genetic variation run out of breath faster and find it harder to partake in aerobic exercises.

These findings could seriously come in handy the next time your co-worker signs you up for that 5K run next month. Sorry, I totally would but my genes just wont cooperate!

To come to their conclusions, the studys authors examined a local patient who exhibited a particularly slow rate of physical growth, constant low blood sugar, a limited ability to exercise, and a large amount of red blood cells.

Over the course of that examination, the patient was placed in a simulated high altitude environment, had their exercise capacity formally measured, and underwent a series of metabolic tests.

This analysis allowed them to zero in on the specific gene that is influenced by this mutation: thevon Hippel-Lindau (VHL) gene. This gene is actually incredibly important for all us whenever our oxygen availability is reduced.

Upon closely analyzing the patients VHL gene, researchers noted that the mutation appears to cause impaired functionality in the mitochondria, the cellular powerhouse that uses oxygen to produce fuel. This hampered mitochondrial function is what causes people with this mutation to have an especially hard time with aerobic exercises.

So, the average persons cells are fully equipped to deal with a lack of oxygen, but those with this mutation dont share the same luxury.

The discovery of this mutation and the associated phenotype is exciting because it enables a deeper understanding of human physiology, especially in terms of how the human body senses and responds to reduced oxygen availability, comments study author Dr Federico Formenti, from KCLs School of Basic & Medical Biosciences, in a press release.

Before you go and cancel your gym membership while citing medical reasons, keep in mind this was an initial observation in one patient. Some days, we would all love an extra excuse to skip the gym and stay on the couch, but these findings are very, very preliminary. As of now, researchers are unsure just how prevalent this gene mutation is, as well as the full extent to which it can impact a persons life.

Regardless, this study is very noteworthy due to the simple fact that it has proven that some people are indeed genetically disinclined to exercising.

The full study can be found here, published in the New England Journal of Medicine.

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The biology of coronaviruses: From the lab to the spotlight – Penn: Office of University Communications

March 10th, 2020 7:45 pm

Things change fast. Even just a few months ago, most of us who arent virologists, microbiologists, or veterinarianshad probably never heard of coronaviruses. Yet last week, the Centers for Disease Control and Prevention advised that its not a question of whether the outbreak of a coronavirus known as SARS-CoV-2 (and its associated disease, COVID-19) would spread in U.S. communities, but whenand we should be prepared for potential disruptions in our daily lives as a result.

But this change didnt come out of nowhere. Even though this particular viral strain only recently emerged as a new human disease, coronaviruses have been around for a very long time. Likewise,Susan Weiss,a professor of microbiology at the Perelman School of Medicine, is newly quite busy launching research projects to help respond to the threat of the novel coronavirusbut coronaviruses generally have been a major focus of her research for four decades.

Coronaviruses first became better known among non-scientists in early 2003 thanks to the virus familys first famous human disease: Severe Acute Respiratory Syndrome (SARS). The agent, called SARS-CoV, started to cause illness in southern China before spreading to North America, South America, Europe, and Asia. It was really scary because there was a high mortality rate, but compared to whats going on now, it was fairly contained and small, Weiss says. Ultimately SARS dissipated within about eight months. Since 2004 there have been no more known cases. But SARS was a warning shotmore viruses like it could be out there, on the verge of transforming into strains that cause serious human illness. Based on analyses of the SARS virus and searches for related genetic sequences in the environment where it emerged, scientists determined that the human virus evolved from a bat coronavirus that infected a civet, from which it mutated again and jumped to humans.

After SARS, people started looking for human coronaviruses, and two others were identified, Weiss says. These new strains caused some more severe symptoms than a typical cold but were still rarely fatal.

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Prefer tea over coffee? It could be your genes, study finds – CNN

March 10th, 2020 7:45 pm

To examine genetic associations with food preferences, researchers from the Riken Center for Integrative Medical Sciences (IMS) and Osaka University in Japan studied the genetic data and food preferences of more than 160,000 people in Japan.

The research, published in the journal Nature Human Behavior, found genetic links for 13 dietary habits including consumption of alcohol, other beverages and foods, and also complex human diseases such as cancer and diabetes.

"We know that what we eat defines what we are, but we found that what we are also defines what we eat," said Yukinori Okada, Senior Visiting Scientist at Riken IMS and professor at Osaka University, in a press release.

This involves grouping thousands of people together depending on whether they have a disease and looking at DNA markers called single nucleotide polymorphisms, or SNPs, which can be used to predict the presence of that disease. If researchers find a SNP that is repeatedly associated with the disease group, they can assume that people with that genetic variation might be at risk for the disease.

Rather than looking at diseases, the Riken team examined dietary habits to find out if there were any markers that made people "at risk" for typically eating certain foods.

The researchers used data of more than 160,000 Japanese people from the BioBank Japan Project, launched in 2003 with a goal to provide evidence for the implementation of personalized medicine. The project collects DNA and clinical information, including items related to participants' lifestyles such as dietary habits, which were recorded through interviews and questionnaires.

They found nine genetic locations that were associated with consuming coffee, tea, alcohol, yogurt, cheese, natto (fermented soy beans), tofu, fish, vegetables and meat.

Variants responsible for the ability to taste bitter flavors were also observed. This association was found among people who liked to eat tofu; while those without the variant consumed less alcohol or none at all.

Those who ate more fish, natto, tofu and vegetables had a genetic variant that made them more sensitive to umami tastes, best described as savory or "meaty" flavors.

The main ingredients of the foods mattered, too -- for example, there were positive genetic correlations between eating yogurt and eating cheese, both milk-based foods.

In order to find whether any of these genetic markers associated with food were also linked with disease, the researchers conducted a phenome study.

The phenome comprises all the possible observable traits of DNA, known as phenotypes. Six of the genetic markers associated with food were also related to at least one disease phenotype, including several types of cancer as well as type 2 diabetes.

Nature vs. nurture: Food edition

Since the research studied only people native to Japan, the same genetic variations associated with food preferences are likely not applicable to populations across the globe. However, similar links have been discovered in different groups.

The study authored by Okada also didn't measure environmental factors. Our environment, demographics, socioeconomic status and culture -- such as whether we eat food from work or home; our age; how much money we make; and what our families eat -- are some of the biggest drivers of our food choices.

"These factors would weigh more than the genetics in some cases," said Dr. Jos Ordovs, director of Nutrition and Genomics at Tufts University in Massachusetts, who was not involved in the study.

"Something that sometimes we have felt is that the nutrition field has been focusing too much on nutrients rather than on foods," Ordovs said.

"Previous studies have been looking at genes that were associating with higher protein intake or higher fat intake or higher carbohydrate intake," Ordovs said. "But this study is more aligned with the fact that people eat foods. They don't just eat proteins, carbohydrates and fats. People tend to eat within a specific pattern."

Further research is needed to explain an exact balance between genetic predisposition and volition when it comes to food choices in different groups of people, but Okada suggests that by "estimating individual differences in dietary habits from genetics, especially the 'risk' of being an alcohol drinker, we can help create a healthier society."

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Repurposed drugs may help scientists fight the new coronavirus – Science News

March 10th, 2020 7:45 pm

As the new coronavirus makes its way around the world, doctors and researchers are searching for drugs to treat the ill and stop the spread of the disease, which has already killed more than 3,800 people since its introduction in Wuhan, China, in December.

The culprit virus is in the same family as the coronavirusesthat caused two other outbreaks, severe acute respiratory syndrome and MiddleEast respiratory syndrome. But the new coronavirus may be more infectious. Inearly March, the number of confirmed cases of the new disease, called COVID-19,had exceeded 100,000, far surpassing the more than 10,600 combined total casesof SARS and MERS.

Health officials are mainly relying on quarantines to try tocontain the virus spread. Such low-tech public health measures were effectiveat stopping SARS in 2004, Anthony Fauci, director of the U.S. NationalInstitute of Allergy and Infectious Diseases, said January 29 in Arlington,Va., at the annual American Society for Microbiologys Biothreats meeting.

But stopping the new virus may require a more aggressive approach. In China alone, about 300 clinical trials are in the works to treat sick patients with standard antiviral therapies, such as interferons, as well as stem cells, traditional Chinese medicines including acupuncture, and blood plasma from people who have already recovered from the virus.

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Researchers are not stopping there. They also are working to develop drugs to treat infections and vaccines to prevent them (SN: 3/14/20, p. 6). But creating therapies against new diseases often takes years, if not decades. With this new coronavirus, now known as SARS-CoV-2, nobody wants to wait that long. Thanks to their experience developing treatments against the MERS coronavirus, as well as other diseases, such as HIV, hepatitis C, influenza, Ebola and malaria, researchers are moving quickly to see what they can borrow to help patients sooner.

Finding new uses for old drugs is a good strategy,especially when racing to fight a fast-moving disease for which there is notreatment, says Karla Satchell, a microbiologist and immunologist atNorthwestern University Feinberg School of Medicine in Chicago.

Repurposing drugs is absolutely the best thing that could happen right now, Satchell says. Potentially, drugs that combat HIV or hepatitis C might be able to put the new coronavirus in check, too. Those drugs exist. Theyve been produced. Theyve been tested in patients, she says. Although these drugs arent approved to treat the new coronavirus disease, theyre a great place to start. One of the most promising candidates, however, hasnt yet been approved for any disease.

Scientists have been quick to reveal the new coronavirussecrets. When SARS emerged in 2002, researchers took about five months to get acomplete picture of the viruss genetic makeup, or genome. With the new virus,Chinese health officials first reported a cluster of mysterious pneumonia casesin Wuhan to the World Health Organization on December 31. By January 10, thenew coronaviruss full genome was made available to researchers worldwide inpublic databases.

A viruss genome is one of the most valuable toolsscientists have for understanding where the pathogen came from, how it worksand how to fight it. The first thing that coronaviruses have in common is thattheir genetic material is RNA, a chemical cousin to DNA.

Researchers immediately began comparing the newcoronaviruss genome with SARS and MERS viruses and other RNA viruses todetermine whether drugs developed to combat those disease-causing organismswould work against the new threat. As a result, some potential Achilles heelsof SARS-CoV-2 have already come to light.

One target is the viruss main protein-cutting enzyme,called M protease. RNA viruses often make one long string of proteins thatlater get cut into individual proteins to form various parts of the virus. Inthe new coronavirus, the M protease is one of 16 proteins that are linked likebeads on a string, says Stephen Burley, an oncologist and structural biologistat Rutgers University in Piscataway, N.J.

The virus can mature and infect new cells only if M proteasecan snip the string of proteins free, he says. Stop the protease from cuttingand the virus cant reproduce, or replicate.

Existing drugs might be able to stop the viruss M protease, two research groups proposed online January 29 at bioRxiv.org. One group suggested four drugs, including one used to treat hepatitis C and two aimed at HIV. A second group named 10candidates, including an anti-nausea medication, an antifungal drug and some cancer-fighting drugs.

HIV and hepatitis C are both RNA viruses that need aprotease to cut proteins free from long chains. Drugs that inhibit thoseproteases can reduce levels of the HIV and hepatitis C viruses to undetectable.Some of those drugs are now being tested against the new coronavirus inclinical trials in China.

The HIV drug Kaletra, also called Aluvia, is a combination of two protease inhibitors, lopinavir and ritonavir. Kaletras maker, the global pharmaceutical company AbbVie, announced on January 26 that it is donating the drug to be tested in COVID-19 patients in China. Kaletra will be tested alone or in combination with other drugs. For instance, researchers may combine Kaletra with Arbidol, a drug that prevents some viruses from fusing with and infecting human cells. Arbidol may be tested on its own as well.

But the HIV drugs may not work against the new virus because of two differences in the proteases. The coronavirus protease cuts proteins in different spots than the HIV protease does, say Guangdi Li of the Xiangya School of Public Health of Central South University in Changsha, China, and Erik De Clercq, a pioneer in HIV therapy at KU Leuven in Belgium. Secondly, the HIV drugs were designed to fit a pocket in HIVs protease that doesnt exist in the new coronaviruss protease, the researchers reported February 10 in Nature Reviews Drug Discovery.

Yet a few anecdotal accounts suggest the HIV drugs may help people with COVID-19 recover. Doctors at Rajavithi Hospital in Bangkok reported in a news briefing February 2 that they had treated a severely ill 70-year-old woman with high doses of a combination of lopinavir and ritonavir and the anti-influenza drug oseltamivir, which is sold as Tamiflu. Within 48 hours of treatment, the woman tested negative for the virus.

Her recovery may be due more to the HIV drugs than to oseltamivir. In 124 patients treated with oseltamivir at Zhongnan Hospital of Wuhan University, no effective outcomes were observed, doctors reported on February 7 in JAMA. Clinical trials in which these drugs are given to more people in carefully controlled conditions are needed to determine what to make of those isolated reports.

Researchers may be able to exploit a second weakness in thevirus: its copying process, specifically the enzymes known as RNA-dependent RNApolymerases that the virus uses to make copies of its RNA. Those enzymes areabsolutely essential, says Mark Denison, an evolutionary biologist atVanderbilt University School of Medicine in Nashville. If the enzyme doesntwork, you cant make new virus.

Denison and colleagues have been testing molecules that muckwith the copying machinery of RNA viruses. The molecules mimic the nucleotidesthat RNA polymerases string together to make viral genomes. Researchers havetested chemically altered versions of two RNA nucleotides adenosine andcytidine against a wide variety of RNA viruses in test tubes and in animals.The molecules get incorporated into the viral RNA and either stop it fromgrowing or they damage it by introducing mutations, Denison says.

One of the molecules that researchers are most excited aboutis an experimental drug called remdesivir. The drug is being tested in peoplewith COVID-19 because it can stop the MERS virus in the lab and in animalstudies. The drug has also been used in patients with Ebola, another RNA virus.

Remdesivir has been given to hundreds of people infected with Ebola, without causing serious side effects, but the drug hasnt been as effective as scientists had hoped, virologist Timothy Sheahan of the University of North Carolina at Chapel Hill said January 29 at the Biothreats meeting. In a clinical trial in Congo, for example, about 53 percent of Ebola patients treated with remdesivir died, researchers reported November 27 in the New England Journal of Medicine. Thats better than the 66 percent of infected people killed in the ongoing Ebola outbreak, but other drugs in the trial were more effective.

Several tests of remdesivir in lab animals infected with MERS have researchers still hopeful when it comes to the new coronavirus. In studies in both rhesus macaques and mice, remdesivir protected animals from lung damage whether the drug was given before or after infection. Molecular pathologist Emmie de Wit of NIAIDs Laboratory of Virology in Hamilton, Mont., and colleagues reported the monkey results February 13 in the Proceedings of the National Academy of Sciences.

Remdesivir appears to be one of the most promisingantiviral treatments tested in a nonhuman primate model to date, the teamwrote. The results also suggest remdesivir given before infection might helpprotect health care workers and family members of infected people from gettingsevere forms of the disease, Sheahan says.

Denison, Sheahan and colleagues tested remdesivir on infected human lung cells in the lab and in mice infected with MERS. Remdesivir was more potent at stopping the MERS virus than HIV drugs and interferon-beta, the researchers reported January 10 in Nature Communications.

But the question is still open about whether remdesivir canstop the new coronavirus.

In lab tests, it can. Both remdesivir and the antimalaria drug chloroquine inhibited the new viruss ability to infect and grow in monkey cells, virologist Manli Wang of the Wuhan Institute of Virology of the Chinese Academy of Sciences and colleagues reported February 4 in Cell Research. Remdesivir also stopped the virus from growing in human cells. Chloroquine can block infections by interfering with the ability of some viruses including coronaviruses to enter cells. Wang and colleagues found that the drug could also limit growth of the new coronavirus if given after entry. Chloroquine also may help the immune system fight the virus without the kind of overreaction that can lead to organ failure, the researchers propose.

In China, remdesivir is already being tested in patients. And NIAID announced February 25 that it had launched a clinical trial of remdesivir at the University of Nebraska Medical Center in Omaha. The first enrolled patient was an American evacuated from the Diamond Princess cruise ship in Japan that had been quarantined in February because of a COVID-19 outbreak.

Ultimately, nearly 400 sick people at 50 centers around theworld will participate in the NIAID trial, which will compare remdesivir with aplacebo. The trial may be stopped or altered to add other drugs depending onresults from the first 100 or so patients, says Andre Kalil, an infectiousdisease physician at the University of Nebraska Medical Center.

Researchers considered many potential therapies, but basedon results from the animal and lab studies, remdesivir seemed to be the onethat was more promising, Kalil says.

In the early patient studies, figuring out when to give remdesivirto patients might not be easy, Sheahan says. Often drugs are tested on thesickest patients. For example, those in the NIAID trial must have pneumonia toparticipate. By the time someone lands in the intensive care unit withCOVID-19, it may be too late for remdesivir to combat the virus, Sheahan says.It may turn out that the drug works best earlier in the disease, before viralreplication peaks.

We dont know because it hasnt really been evaluated inpeople how remdesivir will work, or if it will work at all, Sheahan cautions.

The drug seems to have helped a 35-year-old man in Snohomish County, Wash., researchers reported January 31 in the New England Journal of Medicine. The man had the first confirmed case of COVID-19 in the United States. He developed pneumonia, and doctors treated him with intravenous remdesivir. By the next day, he was feeling better and was taken off supplemental oxygen.

Thats just one case, and the company that makes remdesivirhas urged caution. Remdesivir is not yet licensed or approved anywhereglobally and has not been demonstrated to be safe or effective for any use,the drugs maker, biopharmaceutical company Gilead Sciences, headquartered inFoster City, Calif., said in a statement on January 31.

But global health officials are eager to see the drug testedin people. Theres only one drug right now that we think may have realefficacy, and thats remdesivir, WHOs assistant director-general BruceAylward said during a news briefing on February 24. But researchers in Chinaare having trouble recruiting patients into remdesivir studies, partly becausethe number of cases has been waning and partly because too many trials ofless-promising candidates are being offered. We have got to start prioritizingenrollment into those things that may save lives and save them faster, Aylwardsaid.

Another strategy for combating COVID-19 involves distracting the virus with decoys. Like the SARS virus, the new virus enters human cells by latching on to a protein called ACE2. The protein studs the surface of cells in the lungs and many other organs. A protein on the surface of the new virus binds to ACE2 10 to 20 times as tightly as the SARS protein does.

Researchers at Vienna-based Apeiron Biologics announced February 26 that they would use human ACE2 protein in a clinical trial against the new coronavirus. When released into the body, the extra ACE2 acts as a decoy, glomming on to the virus, preventing it from getting into cells.

ACE2 isnt just a viruss doorway to infection. Normally, it helps protect the lungs against damage, says Josef Penninger, an immunologist at the University of British Columbia in Vancouver and a cofounder of Apeiron. Penninger and colleagues reported the proteins protective qualities, based on studies with mice, in Nature in 2005.

During a viral infection, the protein is drawn away from thecell surface and cant offer protection. Penninger thinks that adding in extraACE2 may help shield the lungs from damage caused by the virus and by immunesystem overreactions. The protein is also made in many other organs. Penningerand colleagues are testing whether the new virus can enter other tissues, whichmight be how the virus leads to multiple organ failures in severely ill people.

The decoy protein drug, called APN01, has already beenthrough Phase I and Phase II clinical testing. We know its safe, Penningersays. Now researchers just need to determine whether it works.

No one knows whether any of these approaches can help stemthe spread of COVID-19.

Right now, we need lots of people working with lots ofideas, Satchell says. Similarities between the viruses that cause SARS andCOVID-19 may mean that some drugs could work against both. There is a hopethat several small molecules that were identified as inhibitors of the SARSprotease would represent reasonable starting points for trying to make a drugfor the 2019 coronavirus, Burley says.

The open questionis, can you produce a drug that is both safe and effective quickly enough tohave an impact? SARS was stopped by traditional infection-control measures in2004, before any virus-fighting drugs made it through the development pipeline.

But had a decision been made then to spend $1 billion tomake a safe and effective drug against SARS, Burley says, such a drug might beworking now against the new coronavirus, eliminating the need to spend hundredsof billions of dollars to contain this new infection.

An investment in SARS would not have paid off for peoplewith MERS, which is still a danger in the Middle East. The MERS virus is toodifferent from SARS at the RNA level for SARS drugs to work against it.

But a future coronavirus might emerge that is similar enough to SARS and SARS-CoV-2 to be worth the cost, Burley says. Even if the current outbreak dwindles and disappears, he says, governments and companies should keep investing in drugs that can stop coronaviruses.

Im quite certain that the economic impact of the epidemic is going to run into the hundreds of billions, he says. So you would only need a 1 percent chance of something that was treatable with the drug to show up in the future to have made a good investment.

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Penn is fighting pancreatic cancer – Penn: Office of University Communications

March 10th, 2020 7:45 pm

Swept up in a pancreatic cancer diagnosis is inevitably a sense of fear and sadness.

But at Penn, researchers are bringing new hope to this disease. And with patients like Nick Pifani, its clear that theyre moving in the right direction.

Pifani, from Delran, New Jersey, first noticed some lingering stomach upset in February 2017. He called his family doctor, concernedespecially given that he was an otherwise healthy marathon runner who was only 42. He was sent to a gastrointestinal specialist. A few weeks later, some crippling stomach pain sent him back to the emergency room and he received an MRI that showed a mass on his pancreasStage Three, inoperable, he was told.

He was treated with chemotherapy, along with radiation and, eventually, and after receiving advice from doctors at Penn, his tumor was removed. Thereafter, he realized he had a PALB2 mutationa cousin of the BRCA gene mutation. At that moment, his long-term needs changed and he found himself seeking specialized care at Penn, where he met Kim Reiss Binder, assistant professor of medicine at the Hospital of the University of Pennsylvania (HUP).

Im a planner; I want to understand what [my] potential options are, Pifani says. [Reiss Binder] asked why I was there to see her and I explained and quickly I could tell she wasoutside of her being remarkably intelligenta great listener and a compassionate doctor.

I have a feeling she worries about me more than I do, he laughs.

Pifani has now been in remission for two years and four months; he sees Reiss-Binder every three months for checkups. His survival story is inspiring and a sign of momentum, even if a world without pancreatic cancer is still frustratingly out of reach.

Pancreatic cancer is the third-leading cause of cancer-related death in the United States, outmatched only by lung cancer (No. 1) and colorectal cancer (No. 2). A person diagnosed with pancreatic cancer is still unlikely to survive past five yearsonly 9%of survivors do, giving it the highest mortality rate among every major cancer.

In short, pancreatic cancer seldom paves the way for optimistic narratives. Some of the hope that has surfaced, though, is thanks to some talent, dedication to the cause, and hard work at Penn.

A key point of progress in the battle against the disease was made in 2002, when former Assistant Professor of Medicine David Tuveson established a standard model for examining human development of this disease in mice. This model has allowed for a reliable way to study the disease and has influenced progress made here at Penn and elsewhere since.

Theres been a burst of activity in translational research, from bench to bedside, explains Ben Stanger, the Hanna Wise Professor in cancer research and director of the Penn Pancreatic Research Center (PCRC).

And theres a lot of momentum with community building, a dramatic increase in patient volumes, and a dramatic increase in what we know about the cancer, he says of the status of pancreatic cancer today.

Reiss Binder, meanwhile, explains that one mark of progress at Penn and beyond has been learning about people like Pifani, who have the PALB2 gene, and why they respond differently to treatments than those without it. Platinum-based chemotherapies, for example, are especially effective for people with the PALB2 gene who are battling pancreatic cancer. An ongoing trial at Penn has tested and found some success with using PARP inhibitorstaken orally as an enzyme that fixes single-stranded breaks of DNAas a maintenance therapy in that same PALB2 demographic after theyve had chemotherapy. These are less toxic than chemotherapy for patients with the same mutations.

Its all been slow progress toward better treatments, but there has been progress.

This is the tip of the iceberg for a disease that we historically have treated with perpetual chemotherapy,Reiss Binder says. We owe it to patients to find better options to suppress the cancer but not ruin their quality of life.

The consensus on why pancreatic cancer is so deadly? It just cant be spotted fast enough.

Pancreatic cancer often presents well after it has developed and metastasized, and does so in a way that is not easy to recognize as cancer. Common symptoms include, for example, stomach upset and back pain. And by the time a harder-to-ignore symptom of the cancer surfaces, a sort of yellowing of the skin (a result of a bile duct blockage), its likely too late to stop the cancer in its tracks.

One approach to improved detection being tested at Penn, by Research Assistant Professor of Medicine Erica Carpenter, is a liquid biopsydrawn from a standard blood test. Current means to test for pancreatic cancerimaging through an endoscopic tubeare invasive and expensive, meaning a common liquid test could transform how many cases are detected early.

Carpenter explains that circulating tumor cells (CTCs) can shed from a tumor thats adjacent to the wall of a blood vessel; whats shed then shows up in a blood test. The cells, if detected, can explain more about the nature of the tumor, giving doctors an opportunity to examine characteristics of cancerous cells and decide how to effectively treat a tumor if it cant be surgically removed. It also allows interpretations of disease burden and the effectiveness of medicationsthrough genome sequencingthat imaging does not.

Ultimately, this gives doctors the potential to track the growth of a tumor before its fully developed, all through one tube of blooddetected through an innovative use of technology.

David Issadore, associate professor of bioengineering and electrical and systems engineering in the School of Engineering and Applied Science, has worked since 2017 to develop a chip that detects cancer in the blood, using machine learning to sort through literally hundreds of billions of vesicles and cells, looking for these CTCs. The chip retrieves data and the machine learning developed interprets that data, attempting to make a diagnosis that not only finds pancreatic cancer but also provides information about its progressionand, importantly, whether a patient might benefit from surgery.

Right now, that test has a 24-hour turnaround, he says, but could eventually advance to having a one-hour turnaround. That would be a remarkable mark of progress for discovering the disease earlier when the chip enters a commercial stage.

Pancreatic cancer is a tough disease, and catching it early is hard, Issadore acknowledges. So, we think optimistically but also very cautiously, knowing what a challenging disease its been to make progress on, which is what drew us to the disease in the first place.

Im not an oncologist, he adds, but Im a bioengineer, and people like us who have a different perspective, the hope is we can do something truly [novel] to shift the [state of the disease].

He would eventually like to test the chip in people with other types of cancers, like lung, bladder, and liver.

For now, Penn still uses imaging as the standard of care but Carpenter is confident that blood testing is where were heading, starting with at-risk patients with diabetes and other risk factors.

The most important thing with this would be that when you put a patient on therapy, its good to know as early as possible how likely it is theyre going to respond, she explains. Tumor markers are increasingly valuable because you can avoid toxicity of the therapy, the expense of it, and most importantly you then have the opportunity to put the patient on something that might have more of an effect for them.

The challenge, she adds, is in pancreatic cancer we dont have that many effective therapies.

Another challenge, she adds, is to find the presence of exosomes, small pieces of tumor cells released into the blood stream, which she says are found in abundance among people with pancreatic cancer and could particularly be targeted among people living with diabetes or an intraductal papillary mucinous neoplasm (IPMN). So, at-risk candidates who may not present with the disease currently but are at risk. Several clinical studies and trials are currently taking place at Penn evaluating this.

A related area of interest is determining if people with diabetes, in particular, are developing cancer as part of the diabetes, or developing diabetes from the cancer. Risk factorsdiabetes, genetic markers, etc.continue to be an important area of study with pancreatic cancer.

Immunotherapy is rapidly changing the way patients are treated. And interest in immunotherapy for pancreatic cancer is growing exponentially.

But, its complicated.

We are still learning about the immune system in pancreatic cancer, explains Gregory Beatty, assistant professor of medicine and director of the Pancreatic Cancer Clinical Trials Program within the PCRC.

On one hand, we know that inflammation in the pancreas is a driver of pancreatic cancer. But we also know that T cells in the immune system can attack pancreatic cancer, he says.

The challenge that has surfaced is that T cells in patients living with pancreatic cancer are often weakened or slowed down; they dont divide or proliferate very well; and they have a hard time finding the cancer. That makes harnessing them for therapy a challenge. One idea, though, is to engineer ones own T cells (as inCAR T therapy), while theyre still healthy, to detect and kill pancreatic cancer cells.

Penn recently completed a trial in ovarian cancer, mesothelioma, and pancreatic cancer, using CAR T cells engineered to recognize a protein called mesothelin, which is expressed by pancreatic cancer. The team found that the T cells, when injected into the blood of patients, were safe but had limited activity.

These CAR T cells can kill pancreatic cancer in the lab really well. But why they dont do so in patients still remains a mystery, Beatty says.

It does prove that pancreatic cancer evades the immune system extraordinarily well.

Penn investigators have also done work on CD40, a protein expressed in a wide range of immune cells, explains Bob Vonderheide, the John H. Glick Abramson Cancer Center Professor. Patients are responding to treatment with CD40a protein that activates T cells to work more steadfastly and seek out cancer cells.

It seems to make chemo work better, Beatty explains.

This is a very promising treatment for convincing the immune system to attack pancreatic cancer, Beatty adds, And in the lab, we are finding ways to make it work even better.

The larger idea is to build on a backbone of chemo and CD40 in the future to help coax T cells to work better. Overall, a major thrust of treatment for patients at the PCRC is focused on unraveling ways to use immunotherapy while developing the next-generation of strategies for patients with BRCA 1 and 2 genes who are receiving PARP inhibitors.

The stress of a pancreatic cancer diagnosis can be dizzying. It is, says Pancreatic Nurse Navigator Trish Gambino, a cause to act fast.

We really believe pancreas cancer is a medical emergency much like a heart attack, she says. As a nurse navigator, I try to get newly diagnosed patients with pancreatic cancer expeditiously to the correct provider for staging and treatment.

Because of that, she says, patients are often still digesting their diagnosis while also juggling appointments, choosing a doctor, making decisions about care, settling personal matters, and communicating with insurance companies. Gambino, one of eight nurse navigators hired to put organization and compassion on the frontlines, takes multiple incoming callsas many as fiveper day from people who have been diagnosed and sound shell-shocked.

I get so many of these calls per week saying, Trish, I just went to the doctor and they told me I have a pancreatic mass on my CAT scan. And I dont know what to do, she says. A lot of times patients dont know what they need.

Her job is one of compassion but also pragmatism. She listens and places their concerns in context and individualizes her approach to moving patients in the right direction, laying out all the options and giving them a sense of order and control over their narrative.

It really does take a village to try to get people through this, Gambino explains, noting how overwhelming the cancer experience can be. When you have pancreas cancer, its not just the medical oncologist, the radiation oncologist, the surgeon, the dietician, the social worker, the nurse navigator, the infusion nurses, the nurse practitionerstheyre all there and the response is often Who is everybody? They need someone who can lead the team for them.

She says that Penn is especially well-regarded for its interdisciplinary teamseven factoring in diet and financial wellnessand their ability to act swiftly. Penn, for instance, performs more than 150 pancreatic cancer surgeries per year and is practiced at itnot typical of every hospital and a draw for newly diagnosed patients who are eligible for resection.

Looking ahead, Stanger is optimistic about advances in screening and immunotherapy treatmentparticularly research funded by the Parker Institute for Cancer Immunotherapy, started by Sean Parker, a cofounder of Facebook. Penn is one of 10 sites of major investment for research and was the impetus for the investment in pancreatic cancer.

Hes also encouraged that the research community surrounding pancreatic cancer is collaborative, he says, with many doctors recognizing the enormous challenge of the disease and working together well.

Celebrity diagnoses, like that of Alex Trebek, als0lend some hope in the messaging of how the disease is presented to the world today.

I talk to people almost every day, and when we talk about pancreatic cancer they say, Oh, thats a really bad one, he says. One thing I respect about Alex is he came out and was very forthcoming and he spoke with a great deal of confidence and hope in the medical community and gave a positive message that said, Im going to do my best to beat this.

Pifani, meanwhile, more than two years out from his surgery, is feeling optimistic. Hes mostly resumed a normal lifewith occasional side effects that linger, of course, and scans every six months. He runs marathons and spends time with his wife and kids. And, a member of the Survivor Council at the Pancreatic Cancer Action Network and sponsorship chair for the Philadelphia affiliate, he shows up to community events built around raising awareness of the disease and advocating research and caregiver support.

At Penn, he says, he feels like hes in the right place with his carethat hes in the best hands if something does happen, and recognizing the diseases ongoing presence in his life.

I got a long way to go, he says, but were off to a good start.

Homepage photo: Gregory Beatty, assistant professor of medicine and director of the Pancreatic Cancer Clinical Trials Program within the Penn Pancreatic Cancer Research Center, examines a blood sample.

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Global Animal Biotechnology Industry Insights, 2018-2028 Featuring Profiles of ~124 Players and 110 Collaborations – GlobeNewswire

March 10th, 2020 7:45 pm

Dublin, March 10, 2020 (GLOBE NEWSWIRE) -- The "Animal Biotechnology - Technologies, Markets and Companies" report from Jain PharmaBiotech has been added to ResearchAndMarkets.com's offering.

Share of biotechnology-based products and services in 2018 is analyzed and the market is projected to 2028. The text is supplemented with 36 tables and 6 figures. Selected 260 references from the literature are appended.

Approximately 124 companies have been identified to be involved in animal biotechnology and are profiled in the report. These are a mix of animal healthcare companies and biotechnology companies. Top companies in this area are identified and ranked. Information is given about the research activities of 11 veterinary and livestock research institutes. Important 110 collaborations in this area are shown.

The report contains information on the following:

This report describes and evaluates animal biotechnology and its application in veterinary medicine and pharmaceuticals as well as improvement in food production. Knowledge of animal genetics is important in the application of biotechnology to manage genetic disorders and improve animal breeding. Genomics, proteomics and bioinformatics are also being applied to animal biotechnology.

Transgenic technologies are used for improving milk production and the meat in farm animals as well as for creating models of human diseases. Transgenic animals are used for the production of proteins for human medical use. Biotechnology is applied to facilitate xenotransplantation from animals to humans. Genetic engineering is done in farm animals and nuclear transfer technology has become an important and preferred method for cloning animals. There is a discussion of in vitro meat production by culture.

Biotechnology has potential applications in the management of several animal diseases such as foot-and-mouth disease, classical swine fever, avian flu and bovine spongiform encephalopathy. The most important biotechnology-based products consist of vaccines, particularly genetically engineered or DNA vaccines. Gene therapy for diseases of pet animals is a fast developing area because many of the technologies used in clinical trials humans were developed in animals and many of the diseases of cats and dogs are similar to those in humans.RNA interference technology is now being applied for research in veterinary medicine

Molecular diagnosis is assuming an important place in veterinary practice. Polymerase chain reaction and its modifications are considered to be important. Fluorescent in situ hybridization and enzyme-linked immunosorbent assays are also widely used. Newer biochip-based technologies and biosensors are also finding their way in veterinary diagnostics.

Biotechnology products are approved by the Center for Veterinary Medicine of the FDA. Regulatory issues relevant to animal biotechnology are described.

List of Topics Covered

Executive Summary1. Introduction to Animal Biotechnology2. Application of Biotechnology in Animals3. A Biotechnology Perspective of Animals Diseases4. Molecular Diagnostics in Animals5. Biotechnology-based Veterinary Medicine6. Research in Animal Biotechnology7. Animal Biotechnology Markets8. Regulatory Issues9. Companies Involved in Animal Biotechnology10. References

For more information about this report visit https://www.researchandmarkets.com/r/qbm3p5

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Global Animal Biotechnology Industry Insights, 2018-2028 Featuring Profiles of ~124 Players and 110 Collaborations - GlobeNewswire

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Vident Investment Advisory LLC Buys Shares of 2,197 Sarepta Therapeutics Inc (NASDAQ:SRPT) – Redmond Register

March 10th, 2020 7:45 pm

Vident Investment Advisory LLC bought a new stake in Sarepta Therapeutics Inc (NASDAQ:SRPT) in the fourth quarter, according to its most recent 13F filing with the Securities & Exchange Commission. The fund bought 2,197 shares of the biotechnology companys stock, valued at approximately $284,000.

A number of other hedge funds also recently modified their holdings of SRPT. Evolution Wealth Advisors LLC boosted its stake in Sarepta Therapeutics by 1,143.8% in the fourth quarter. Evolution Wealth Advisors LLC now owns 199 shares of the biotechnology companys stock valued at $26,000 after acquiring an additional 183 shares during the period. San Francisco Sentry Investment Group CA acquired a new position in Sarepta Therapeutics in the fourth quarter valued at approximately $34,000. Lighthouse Financial Advisors Inc. acquired a new position in Sarepta Therapeutics in the fourth quarter valued at approximately $42,000. Advisory Services Network LLC boosted its stake in Sarepta Therapeutics by 531.4% in the fourth quarter. Advisory Services Network LLC now owns 322 shares of the biotechnology companys stock valued at $42,000 after acquiring an additional 271 shares during the period. Finally, Tower Research Capital LLC TRC acquired a new position in Sarepta Therapeutics in the third quarter valued at approximately $47,000. Institutional investors own 97.11% of the companys stock.

SRPT has been the subject of a number of research reports. HC Wainwright lifted their target price on Sarepta Therapeutics from $160.00 to $260.00 in a research note on Friday, December 13th. JMP Securities decreased their target price on Sarepta Therapeutics from $280.00 to $217.00 and set an outperform rating for the company in a research note on Thursday, February 27th. Oppenheimer reiterated a hold rating on shares of Sarepta Therapeutics in a research report on Monday, December 30th. Cowen reiterated a buy rating and set a $213.00 price objective on shares of Sarepta Therapeutics in a research report on Tuesday, January 14th. Finally, Royal Bank of Canada reduced their price objective on Sarepta Therapeutics from $215.00 to $200.00 and set an outperform rating for the company in a research report on Monday, December 23rd. Two equities research analysts have rated the stock with a hold rating, twenty-four have issued a buy rating and one has assigned a strong buy rating to the company. The company currently has a consensus rating of Buy and an average target price of $193.95.

SRPT traded down $9.97 during trading on Monday, reaching $107.13. The stock had a trading volume of 42,503 shares, compared to its average volume of 733,097. The firm has a market capitalization of $9.34 billion, a price-to-earnings ratio of -11.21 and a beta of 2.08. The company has a quick ratio of 4.90, a current ratio of 5.55 and a debt-to-equity ratio of 0.89. Sarepta Therapeutics Inc has a 1-year low of $72.05 and a 1-year high of $158.80. The stock has a 50 day moving average of $119.68 and a two-hundred day moving average of $105.71.

Sarepta Therapeutics (NASDAQ:SRPT) last released its earnings results on Wednesday, February 26th. The biotechnology company reported ($3.16) earnings per share for the quarter, missing analysts consensus estimates of ($1.86) by ($1.30). The firm had revenue of $100.11 million during the quarter, compared to analyst estimates of $100.10 million. Sarepta Therapeutics had a negative return on equity of 67.13% and a negative net margin of 187.77%. During the same quarter last year, the company earned ($2.05) earnings per share. On average, research analysts forecast that Sarepta Therapeutics Inc will post -8.22 EPS for the current fiscal year.

Sarepta Therapeutics Company Profile

Sarepta Therapeutics, Inc focuses on the discovery and development of RNA-based therapeutics, gene therapy, and other genetic medicine approaches for the treatment of rare diseases. The company offers EXONDYS 51, a disease-modifying therapy for duchenne muscular dystrophy (DMD). Its products pipeline include Golodirsen, a product candidate that binds to exon 53 of dystrophin pre-mRNA, which results in exclusion or skipping of exon during mRNA processing in patients with genetic mutations; and Casimersen, a product candidate that uses phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 45 of the DMD gene.

Further Reading: Balance Sheet

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Vident Investment Advisory LLC Buys Shares of 2,197 Sarepta Therapeutics Inc (NASDAQ:SRPT) - Redmond Register

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What is vitamin D good for: Bone, brain, and immune system health – Insider – INSIDER

March 9th, 2020 7:49 pm

Vitamin D's main function is to promote bone health, but it helps with other necessary bodily functions, as well. That's why it's important to make sure you are getting a proper amount of vitamin D, as too little or too much vitamin D can be harmful. Here's what you need to know.

Maintains strong bones: Vitamin D promotes bone health by helping the body absorb calcium, which is a mineral crucial to keeping bones strong. "Calcium is not very well absorbed by the human intestines. Calcium in your bloodstream interacts with the vitamin D in your blood that goes and activates cells in your bone to help you make stronger bones," says David Cutler, MD, family medicine physician at Providence Saint John's Health Center.

Promotes muscle strength: Vitamin D can aid in keeping muscles strong. A study published in Plos One in 2017 showed a positive correlation between muscle strength and vitamin D intake.

Boosts immune system: Vitamin D is crucial for a healthy immune system and good health. Immune system cells such as B cells (cells that produce antibodies) and T cells (cells that are critical to the immune response) have receptors for vitamin D. Essentially, the vitamin helps keep the immune system balanced.

Aids in brain function: Researchers believe there is a link between vitamin D and neurological function. Vitamin D can promote brain development and prevent neurodegenerative conditions. Additionally, preliminary research suggests there may be a link between low vitamin D levels and depression.

Vitamin D deficiency can lead to several negative outcomes. Certain groups of people, such as people with dark skin, obese people, and elderly people, should be especially careful in making sure they get enough of the vitamin since they're more predisposed to Vitamin D deficiency.

According to Cutler, lack of exposure to the sun is one of the main causes of Vitamin D deficiency. A study published in the International Journal of Circumpolar Health in 2008,showed that Vitamin D supplementation is necessary to maintain good health when living in a northern latitude that has very short daylight hours in the winter.

Additionally, having dark skin can be a risk factor. "If you have very dark skin, you'll tend not to absorb as much sunlight, which is what converts vitamin D from its inactive to its active form," says Cutler. Other risk factors are old age, obesity, and people with Crohn's disease or celiac disease, according to the National Institute of Health.

Vitamin D deficiency most commonly affects your bones. In children, vitamin D deficiency can lead to rickets, a condition that results in brittle bones that don't develop properly, causing bowed legs. According to Cutler, this was more common in the 19th and early 20th century, and has become rarer today, thanks to milk and other foods being fortified with vitamin D.

In older adults who are vitamin D deficient, they may have trouble absorbing calcium, which can cause their bones to get weak and brittle. This can contribute to bone disease osteoporosis, says Cutler.

As good as Vitamin D is for you, it is possible to have too much of it. For example, you can experience Vitamin D toxicity if you take too much through supplements. "Vitamin D is in a group of vitamins, which are fat-soluble, unlike the more common vitamins like C and B, which are water-soluble," says Cutler.

If you take too many water-soluble vitamins, they'll go through your kidneys and be flushed out through urination. However, fat-soluble vitamins like vitamin D can get absorbed into your body's fatty tissue, liver, and even the brain, according to Cutler. So, your body has a harder time removing excess amounts. That's why it's important not to overdose on any fat-soluble vitamins, including vitamin D.

Signs of vitamin D toxicity include nausea, vomiting, weakness, confusion, and even kidney damage. Cutler says that this really only can happen from taking too many supplements. According to Mayo Clinic, the daily recommended amount of vitamin D for children and adults is 600 IU. A toxic level is around 4,000 IU. Your body will not produce toxic amounts of vitamin D from sun exposure.

Additionally, while some people believe vitamin D has anti-cancer properties, the opposite can be true. A study, published in the International Journal of Cancer in 2019, found a link between high levels of vitamin D with higher incidences of skin, prostate, and blood cancers, but a lower incidence of lung cancer.

If you're concerned that you're getting too little or too much vitamin D, speak to your doctor. Blood tests can be ordered to check the levels of the vitamin in your blood, and then you can determine what changes, if any, need to be made.

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What is vitamin D good for: Bone, brain, and immune system health - Insider - INSIDER

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Drink To Your Health With These 15 Immune-Boosting Cocktails – Forbes

March 9th, 2020 7:49 pm

Theres a whole lot of scary germs in the world. Stopping for a cocktail wont change that, but a little boost to the immune system via the right ingredients never hurt!

The Remedy

The Remedy at Even Keel Fish and Oyster in Fort Lauderdale, Florida.

I grew up in Jamaica where herbs and plants were used to cure everything, so I wanted to create an immune building, anti-inflammatory cocktail inspired by an old family remedy. I use an elixir of roasted, toasted garlic, black pepper, turmeric, ginger, rosemary, honey, lemon juice and Misunderstood Ginger Spiced Whiskey. Between the immune boosting power of ginger, antioxidant rich turmeric and the anti-inflammatory properties of black pepper this family recipe combines plants and herbs that are not only good for you but taste amazing together. Cheers to that! said Gregory Genias, beverage director at Even Keel Fish and Oyster in Fort Lauderdale, Florida.

5-Spice Old Fashioned

5-Spice Old Fashioned at Linger in Denver.

At Linger in Denver, thanks to the addition of Chinese 5-Spice, a powerful combination of spices including cinnamon, Szechuan peppercorns, star anise, fennel seed and clove, this twist on a classic Old Fashioned is a powerhouse of antioxidants, health-improving essential oils and minerals necessary for boosting the immune system. "While 5-Spice is traditionally used in cooking, it also serves as an excellent component in elevating cocktails and in this case, a boozy way to get your daily dose of antioxidants, says Jeff Wilkins, Bar Director at Linger restaurant in Denver, CO. The spice blend is combined with Bourbon, bitters and orange oil resulting in one of our favorite classic cocktails boosted with cold fighting powers, said Jeff Wilkins, bar director.

Giggle Water

Giggle Water at Brezza Cucina in Atlanta.

At Brezza Cucina in Atlanta, Georgia, Giggle Water is crafted with tequila, curacao, lemon, bubbles and a housemade pomegranate-papaya shrub. Don Pirone, Brezza Cucina's beverage director said: "Citrus, pomegranate and papaya are all known to offer immune-boosting benefits, which makes this drink a go-to for keeping germs at bay. Plus, our pomegranate-papaya shrub is made with apple cider vinegar, which also has been said to have a positive impact on immune health."

Mai Tai Cider

Mai Tai Cider at Plunge Beach Resort's Octopus Kitchen & Bar in Lauderdale-By-The-Sea, Florida.

Located in the charming beachfront town of Lauderdale-By-The-Sea, Florida, the Mai Tai Cider is offered at Plunge Beach Resort's Octopus Kitchen & Bar, and delivers a much needed kick to the immune system. Enjoy the health-inducing goodness of mulled apple cider in a light, refreshing "beachy" cocktail. Made with some of the most powerful medicinal properties found in a cocktail, including fresh cranberries, ginger, cinnamon sticks and lime juice, the Mai Tai Cider also comes with an added punch of Bacardi Rum, maple syrup and Orgeat syrup to help take that edge off. After combining the ingredients with ice until chilled, strain into an old-fashioned glass, top with 151 Dark Rum, and garnish with fresh apple and cranberry - cheers to healthy living! When you infuse the warm, spicy flavors of apple, cinnamon and ginger into a cool, fun & refreshing drink like the Mai Tai, you get the Mai Tai Cider. The perfect drink to ward off any sickness during flu season! Take it one step further by jumping in the Atlantic Ocean after you've finished the cocktail for a true saltwater immune booster - we call that the Mai Tai Cider Plunge, said head bartender Abraham Millett.

Butterfly Effect

Butterfly Effect at Outpost Kitchen in Costa Mesa.

In Costa Mesa, Outpost Kitchen's entire bar program focuses on superfood-charged cocktails. Take the Butterfly Effect for example. This gin-based cocktail features a variety of immune-boosting ingredients like blueberries, fresh-pressed cucumber juice, lemon yogurt, honey, and spirulina - a potent superfood which is widely regarded as one of the most nutrient-dense superfoods in the world. Our entire cocktail program was designed to mirror the ethos of our kitchen. Our menu of superfood-infused drinks extracts bold flavors, vibrant colors, and immune-boosting properties from powerful all-natural ingredients like spirulina, moringa, beetroot, turmeric, and tarragon, said Outpost Kitchen founder Jay Lewis.

Masala Nights

Masala Nights At Dot Dot Dot in Charlotte, North Carolina.

At Dot Dot Dot in Charlotte, North Carolina, this drink is made with Topo spiced rum, chai, ginger, cinnamon, cardamom, coconut milk, and served warm. The cocktails base is a traditional chai with black tea and spices. They chose to use coconut milk to make the cocktail vegan. Black tea is known to improve digestion, keep your hormones balanced, and helps protect your cells from free-radicals. Ginger is known to have anti-nausea properties, while also helping reduce inflammation and strengthens the immune system Cardamom and Black Pepper have digestive superpowers, further boosting chais reputation as a potent stomach savior. "I wanted to create a great blustery, cold weather cocktail that warms you up and also makes you feel better. And Ive always loved tea, even since I was young. So I started with a chai (which is the Hindu word for tea) black tea base and added several ingredients and spices known to boost the immune system, like ginger and cardamom." "I used a local spiced rum from Topo Distillery. Their spirits are made exclusively from North Carolina-grown wheat, US-grown sugar cane, and every product is USDA-certified organic and 100% fermented and distilled in Chapel Hill, NC. Domaine de Canton is a French ginger liqueur made from organic Vietnamese baby ginger. The hot cocktail is topped with a fresh, ginger-infused coconut cream whipped topping to create a powerhouse, immune-boosting cocktail! said Brittany Clark, mixologist at Dot Dot Dot.

Pomegranate Nojito

Pomegranate Nojito at ATRIO Wine Bar & Restaurant in New York City.

At ATRIO Wine Bar & Restaurant in New York City, made with fresh pomegranate and blueberries, both rich in health-boosting nutrients, and then garnished with mint and lime this drink is as vibrant as it is flavorful and good for you. Kevin King, director of F&B said: Our Pomegranate Nojito tastes just like a true mojito. The drink features fresh blueberry, which is a fruit known for its fiber, potassium, vitamin C and more. Pomegranate is also loaded with important nutrients and has lots of natural antioxidants.

Thick as Thieves

Thick as Thieves at Madison on Park in San Diego.

At Madison on Park in San Diego, Thick as Thieves is crafted with 1776 Rye Whiskey, Cynar, Thieves Essential Oil and Lo Fi Gentian Amaro. The Thieves Essential Oil is a blend made with cinnamon, clove, eucalyptus radiata, rosemary and lemon essential oils. The combination is inspired by a legend about 15th-century French grave robbers who would use essential oils to protect themselves from diseases. "This is a warming cocktail, that is both spicy and earthy and Thieves is believed to have immune-supporting and antioxidant properties, said bar manager Danny Kuehner.

SAMBA

SAMBA at The Tipsy Alchemist Austin.

At The Tipsy Alchemist Austin, the Samba includes mezcal, fresh lemon juice, honey cinnamon reduction, ginger reduction, and cayenne pepper. Pour all ingredients into your shaker tin, shake and pour into a snifter with round ice, Garnish with a blackened lemon wheel, and a blackened lemon wheel. Cut lemon into a wheel, dust with tajin and cayenne. Blackened with your torch.

Anti-Inflammatory

Anti-Inflammatory at Saffron NOLA in New Orleans.

At Saffron NOLA in New Orleans, inspired by a bedtime elixir of warm milk, honey and turmeric, the Anti-Inflammatory also plays off a New Orleans staple cocktail, the Brandy Milk Punch. The soothing drink luxuriously combines cognac with turmeric-infused coconut milk and honey syrup over crushed ice, garnished with a cilantro sprig and drops of chili oil. "During my upbringing, I was taught to always take care of my gut health to prevent obstruction of nutrients to the rest of my body. This way of thinking has been passed down in my family. Spices including ginger, turmeric, fennel, cinnamon, nutmeg, coriander, cumin and cayenne, are Ayurvedic spices that aid in digestion and metabolism. They also have the benefit of being natural anti-inflammatories. As a family, we used these spices not only for this organic benefit, but also because it enhanced the flavor of the food. We implement the same use of these spices both in our food and cocktail program at Saffron Nola, a true extension of our home kitchen, said Ashwin Vilkhu.

Think Spring

Think Spring at A.Lounge at the AKA Hotel in New York City.

At A.Lounge at the AKA in New York City, this is a refreshing, immune-boosting 'VOSStail' with Vitamin C and antioxidants, Think Spring is a blend of the AKAs own organic vodka (crafted exclusively for the AKA), simple syrup and VOSS Lemon Cucumber Sparkling Water, infused with fresh lemon and cucumber. "Customers are interested in seasonal beverages that are both refreshing and health conscious. The AKA 'Think Spring' VOSStail hits the palate in all the right ways crafted with vitamin-c rich lemon, nutrient dense cucumber, lemon cucumber flavored sparkling VOSS water, and our very own organic vodka (a.vod). This specialty drink satisfies the taste buds and the immune system alike. With the sweater weather behind us, this low calorie count makes it a happy hour favorite, said Kate W. Lewis, AKA mixologist.

Spill the Tea

Spill the Tea at Riot House Bar located inside the Andaz West Hollywood.

At Riot House Bar located inside the Andaz West Hollywood, this cocktail is made with rum, honey, lemon juice, chamomile tea, blackberries, and ginger beer. All the ingredients have their own medicinal qualities; ginger, lemon and blackberries have antioxidants, chamomile tea have flavonoids, type of nutrients, and combining them, create a calming and relaxing drink that can ease symptoms and boost immune system.

That's All, Folks

That's All, Folks At Beaker & Gray in Wynwood, Miami.

At Beaker & Gray in Wynwood, Miami, the cocktail is comprised of gin, carrots, ginger, lemon, cilantro, and a dash of salt for flavor. "The flavorful concoction combines a touch of gin with some healthful ingredients including carrot juice, ginger, and cilantro. Gin's health benefits are questionable, but the use of juniper for kidney-related health issues was widely used....about 200 years ago. Carrots, on the other hand, have Vitamin A, antioxidants, and fiber all of which are great. Ginger has anti inflammatory properties and citrus has Vitamin C. Cilantro is a mineral-rich herb and a dash of salt help give you the electrolytes. Makes for a great way to replenish some vitamins and nutrients," said Ben Potts, bar director.

Lady of Versailles

Lady of Versailles at Mister French NYC.

At Mister French NYC, the Lady of Versailles is your passport to the South of France with perfectly balanced Belvedere Vodka, Calvados and white wine mixed with fresh lime juice, fresh pressed ginger, pineapple juice, fresh pressed cucumber, organic cane reduction, winter melon bitters, and fresh thyme. Steve Mazzuca, the general manager and creative director of the bar program, says, "Here at Mister French when we say 'drink to your health', we actually mean it. So many of these components are powerful sources of antioxidants that also promote healthy digestion along with anti-inflammatory properties. They are soaring with vitamin C, which of course is vital for a strong immune system and if I might add...great cocktails as well. I usually joke with our guests saying, if you just take out the alcohol you have yourself a health drink!"

Kyuri

Kyuri at Azabu Miami Beach in Miami Beach.

At Azabu Miami Beach in Miami Beach, this cocktail is made with St Georges Gin, fresh muddled ginger, and fresh muddled cucumber. "Before it became popular as an alcoholic beverage, Gin was used to relieve and help improve digestive problems and juniper berries are also super berries that help our health systems overall. Ginger is a natural antibacterial/ antiviral, and also helps to boost our defenses. Cucumbers help to detox. Gin is a great alternative for someone that suffers from digestive problems caused by foods or other alcoholic beverages so its not all over for those that can not drink other spirits like rum, wine, etc, said head bartender Bryan Mayer.

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Coronavirus updates live: World markets tumble and all of Italy goes on lockdown – NBCNews.com

March 9th, 2020 7:49 pm

Monica Alba

10h ago / 2:00 PM UTC

There are few things President Trump says he enjoys more than a large-scale rally with thousands of cheering supporters. And while he has pledged to keep up the pace amidconcerns about large gatheringas thecoronavirus outbreakintensifies, his re-election campaign has not announced any upcoming rallies for the weeks ahead, marking the first time without one on the calendar this year.

Read more here.

Lucy Bayly

10h ago / 1:58 PM UTC

Trading on Wall Street's major averages was halted for 15 minutes Monday morning after the S&P 500 plunged by 7 percent, triggering a "circuit breaker."

The Dow Jones Industrial Average plummeted at the opening bell, sinking by more than 1,800 points as a fight over crude oil production created heightened pressure on a global economy already suffering the effects of the coronavirus epidemic.

Traders had anticipated a bloodbath on Monday, after oil prices cratered overnight by 30 percent when ongoing talks between OPEC members did not produce an agreement on output cuts.

Ahiza Garca-Hodges

10h ago / 1:54 PM UTC

Amazon has told its warehouse employees that they can take sick days in March without counting toward their unpaid time off, according to CNBC.

The change comes as labor experts have warned that hourly workers and those without sick leave could be at higher risk of both catching the coronavirus and suffering severe financial repercussions as a result.

"We continue to work closely with public and private medical experts to ensure we are taking the right precautions and have implemented a series of preventative health measures for employees, delivery and transportation partners at our sites around the world," an Amazon spokesperson said in a statement.

Stella Kim and Yuliya Talmazan

11h ago / 1:03 PM UTC

South Korea's president said Monday his nation could become "a model case" for dealing with the novel coronavirus if the number of new confirmed cases continued to decrease, but cautioned against being too optimistic about the progress being made.

"The number of new coronavirus confirmed cases peaked to 916 on Feb. 28 and has since been steadily decreasing to 248 on [Sunday]. This trend must continue, President Moon Jae-In said at a presidential staff meeting. As the number of new cases continues to grow in many countries around the world, if we continue with a decrease in the curve, South Korea can be regarded as a model case for good practice for COVID-19 protection.

But Moon said small group infections are still occurring in areas including Daegu and North of Gyeongsang province.

The continued small-scale infections can mean that infections can occur on a larger scale as well, he added. "We should not be relieved by the situation."

South Korea reported 7,478 confirmed cases and 53 virus-related deaths Monday.

Andy Eckardt and Yuliya Talmazan

11h ago / 12:47 PM UTC

A NATO staff member working at the Brussels headquarters has tested positive for coronavirus, the alliance said Monday.

The staff member came back from a holiday in northern Italy, felt unwell at the end of last week and was tested after getting fever-like symptoms, according to a statement from NATO.

"Within minutes of receiving the result, all the immediate work colleagues were informed," the statement added.

The staff member, who wasn't named,is currently working from home, where they are in self-isolation.

NATO said it has already taken preventative measures at its headquarters to reduce the risk of virus spread, includingtemporary suspension of travel for some staff and group visits to NATO headquarters in Brussels.

Amin Hossein Khodadadi and Yuliya Talmazan

12h ago / 12:13 PM UTC

Health officials in Iran reported nearly 600 new coronavirus cases, increasing the total to7,161 as the country struggled to contain the outbreak.

Health ministry spokesman Kianoush Jahanpour said a total of 237 people have died from the virus since the epidemic began, with 43 new deaths reported Monday.

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Coronavirus updates live: World markets tumble and all of Italy goes on lockdown - NBCNews.com

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Concerned about getting sick? Here’s what you should eat to boost your immunity – WTSP.com

March 9th, 2020 7:49 pm

TAMPA, Fla. You've probably been focusing on the basics to keep from getting sick washing your hands and disinfecting your home and work areas.

But staying healthy isn't just about cleanliness and hygiene. What you put in your body is just as important because eating right can help maintain your immune system.

"There's no one specific diet that is an immune booster," Dr. Crystal Jacovino said. She's an Assistant Professor of Internal Medicine and Endocrinology at USF Health.

That's because the immune systemis exactly that a network of cells, tissues, proteins and organs working together with a common mission. Jacovino says maintaining the immune system is more of a lifestyle.

"It is a marathon, not a sprint. We are preparing our bodies, preparing our immune systems the whole year long. It doesn't do any good to all the sudden eat your vegetables during cold and flu season," Jacovino said.

"We want to train ourselves for the whole year by making healthy choices."

So, what should we be eating?

"I recommend lots of fresh fruits and vegetables, lean proteins. I also recommend avoidance of certain foods, such as fried or fatty foods, red meats, sodas, juices, things like that," Jacovino said.

Here are five things to think about adding to your diet right now:

And of course drink lots of water to stay hydrated!

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UT Southwestern researchers help identify human protein that inhibits coronavirus – The Dallas Morning News

March 9th, 2020 7:49 pm

Researchers at UT Southwestern have helped identify a human protein they say inhibits the coronavirus.

The protein LY6E is produced naturally by the human immune system, and the researchers say it impairs the ability of several coronaviruses to initiate infection, including the one fueling the current COVID-19 outbreak.

This protein seems to be able to stop the ability of the virus to ... [cause infection], or at least hinder it pretty significantly, said Dr. John Schoggins, associate professor in UT Southwesterns microbiology department.

The group which also includes researchers from New York and Switzerland detailed their findings in a report published Saturday, but the report has yet to be peer-reviewed.

Schoggins first researched the protein several years ago in a lab in New York. At the time, he discovered that LY6E enhanced influenza infection.

Another researcher at the lab used Schoggins screening technology in 2017 and determined LY6E inhibited coronavirus infection.

The team of scientists had worked for years on its study of the protein before the current outbreak, Schoggins said.

As the new coronavirus spread in Wuhan, China, and beyond, researchers in Switzerland worked to figure out whether the protein was effective against it, he said. They determined it was.

Meanwhile, UT Southwestern researchers examined the protein in mice and determined they are more susceptible to coronavirus when their cells lack the protein.

Schoggins noted however that coronavirus in mice is different from coronavirus in humans. The illness infects the liver in mice, causing hepatitis. Meanwhile, coronavirus causes a respiratory illness in humans.

In spite of those differences, its widely accepted as a model for understanding basic concepts of coronavirus replication and immune responses in a living animal, Schoggins said in a written statement. Our study brings new insight into how critical these antiviral genes are for controlling viral infection and mounting proper immune responses against the virus.

He cautioned that the researchers arent claiming to have found a cure for the virus. The work is simply focused on how a naturally occurring protein interacts with the virus.

The team will need more time to see whether the information can be used to advance therapeutic options for COVID-19.

This is sort of natures antiviral defense system, he said of the LY6E protein. We figured out how nature figured out how to inhibit these viruses. Can we do something as scientists to do the same thing?

He added that its still not certain whether the protein has helped infected people recover during the current outbreak. But he noted that the majority of people survive the illness.

Its key for the public to remember that, in general, our immune systems handle viruses pretty well," he said. "It remains to be seen if in humans our protein contributes to that. But at least in the mouse, the datas very clear that the immune system is very reliant on this ... protein to control the mouse coronavirus.

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UT Southwestern researchers help identify human protein that inhibits coronavirus - The Dallas Morning News

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Augmenting the immune system is key to eliminating COVID-19 – Prof Duncan – Ghana News Agency

March 9th, 2020 7:49 pm

ByChristabel Addo, GNA

Accra, March 9, GNA- Professor Samuel Ato Duncan, Executive President, Centre of Awareness (COA)Global Peace Mission, on Monday, called for an urgent global partnership inconducting research on its products to ascertain their clinical effectivenessagainst the COVID-19.

He said COA FS,which is a dietary supplement, has proven to boost the immune system to fight avariety of diseases and repair compromised tissues for full recovery.

Prof Duncan appealedto Government, World Health Organisation (WHO), affected and unaffectedcountries worldwide, the Noguchi Memorial Institute for Medical Research,University of Ghana, and other local and international research institutions tojoin hands with the Centre of Awareness to conduct the study as soon aspossible.

Prof Duncan, who wasaddressing a press conference in Accra, said augmenting the human immune systemwas key to eliminating the COVID-19.

He explained thatall diseases affecting mankind these days took seat in the body when the immunesystem was suppressed.

He said on the otherhand, if the immune system was functioning properly, it identifies a variety ofdisease-causing organisms including viruses, bacteria, fungi, moulds and otherparasites, and distinguished them from the bodys own healthy tissues fordestruction.

Dr Duncan said theCentre believes and hopes that there would be positive results from the trials,and when that occurs, then Ghana and the rest of the world could adopt theformula and the product as the antidote to the COVID-19.

He said the fastrate at which the COVID-19 was spreading across the globe, poses a seriousthreat to global peace, hamper supply chains, lead to stigma, mistrust andviolations of the principles of the International Health Regulations.

Dr Duncan said inthe quest to find an antidote to the CODVI-19, the Centre, about two weeks agosent some of its COA products to China via an individual, to be tried onpatients infected with the virus.

He said informationreaching us indicates that there has been a significant improvement in thecondition of some infected patients who were given COA products.

He said even thoughthis was good news, it was not scientific and not conclusive, and that was whyit was calling for further collaborative research for wider empirical evidence.

He said the visionof the Centre is to be a selfless Non-Governmental Organisation with a divinemission poised at looking at the total welfare and wellbeing of humanity onearth.

The Center alsoseeks to ensure a peaceful world, free from wars, political, and socialinjustice, ethnic conflicts, religious rivalry, discrimination, racism,poverty, immorality, selflessness, and greediness.

It also seeks tofind cure for diseases that has no cure like HIV, cancers and renal failures.

GNA

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Covid-19 Biologic Therapies Reviewed – Science Magazine

March 9th, 2020 7:49 pm

Friday I looked over the small-molecule landscape in this post, which has been updated and will continue to be as more news comes along. Today lets look at the biologics landscape. One thing that I want to emphasize up front, as I did in the earlier post, is that none of these things are available right now, and that its very likely that none of them will be available for many months even if things run as quickly and perfectly as possible.

The anti-corona biologics field divides into several smaller categories (well get to those) and two large ones, antibodies and vaccines. The way to think of that is that the former would be dosing external antibodies that have already been targeted to some part of the coronavirus, while the latter would encourage your own immune system to raise such antibodies itself. There is an overview list here at BioCentury, open-access.

Where do you get such external antibodies? Takeda has an effort underway to isolate them from the plasma of people who have already developed immunity (immunoglobulin therapy). This program (TAK-888) would take around a year, give or take some months, to start treating high-risk patients. But how many? One recovered-patients worth of plasma might only be enough to treat one other person; we just dont know. It might be a bit better; it could be worse. So this is going to be something for people who are in bad shape and need something immediate. This technique gets broken out during severe epidemics, and has already been tried on an emergency basis in China, but we really dont have any well-controlled data to work with yet. The hope is that such a therapy could skip Phase I (immunoglobulin therapy has a long history of clinical use) and go straight into Phase II, then perhaps skip an actual Phase III and let clinical evidence accumulate in real-world use. Well see.

The isolate-from-plasma route has the advantage of being polyclonal (a mixture of antibodies to several different features of the viral proteome), but that has a potential disadvantage as well, as pointed out here. Antibody-dependent enhancement is a concern for this sort of therapy and for vaccines as well in general, the antibodies developed against one virus can actually make later infections with later viruses even worse. If the antibodies bind to the new viral proteins but do not actually neutralize them, they can enhance cellular uptake of them, which is exactly what you dont want.

There are also a number of organizations working on monoclonal antibodies to particular coronavirus proteins (heres another recent summary of this area, PDF here). As youll see in that papers Table 1 and Table 2, there are a number of epitopes that were targeted for the SARS and MERS coronaviruses (an epitope, for those just jumping into this subject, is an exposed region on a protein that you can potentially raise an immune response to). This new coronavirus, like the others, bristles with spike proteins that interact with human cell receptor proteins, so those are high on the list. Were seeing similar work being done right now on 2019-nCoV; see the bottom of the page on that BioCentury list linked in the first paragraph).

When would these come on line? Monoclonal antibody production is a big industrial field, and theres a lot of expertise out there. Regenerons CEO (Lenny Schleifer) said last week that the company could get 200,000 doses/month coming from their own production in August, but we have to remember that he was saying that in front of President Trump at a White House meeting. To my eyes, thats about as optimistic an estimate as one could possibly commit to; I would expect things to take longer (and note that Schleifer appears to be just talking about the production aspect, not the demonstration of efficacy and safety in the clinic).

Now to vaccines. That list Ive been referring to has a long string of people working in this area, and thats a good thing, because a vaccine is probably the best long-term solution. A safe and effective vaccine, let me amend that, while noting that proving both of those is what makes vaccine development the field it is. You have the antibody-enhancement problem mentioned above, you have the potential for a pathogen to mutate its way out of efficacy, and you always have the risk of immunological side effects. Readers my age and older will recall the 1976 swine flu debacle, in which a huge campaign was launched to vaccinate the public against an epidemic that never actually materialized, while also setting off hundreds of well-publicized cases of Guillain-Barr syndrome. That is a well-known immune disorder that usually occurs after a mild viral infection, where the nervous systems myelin sheaths come under attack. It generally resolves, but not always, and can land patients in intensive care. The swine flu vaccine (a live-attenuate-virus preparation) is the largest vaccine-driven GBS incident that Im aware of, and we do not want to repeat that.Vaccines by definition are being given to large numbers of healthy people its vital that you do not cause more trouble than youre trying to prevent.

That said, I have little doubt that a good 2019-nCoV vaccine can be realized. But that too is going to take time, and its definitely not going to be coming on in time to help us right now. No one knows if were going to be seeing this pathogen as a regular feature in human disease or if it will disappear like some others have. Its reasonably likely that the virus will decrease in the currently affected areas during the warmer months (perhaps becoming more of a problem in parts of the Southern hemisphere?), but we dont know that for sure, either. If its going to be with us, though, we will be vary glad of a vaccination program.

What that vaccine will look like is anyones guess. There are a lot of traditional development programs underway, along with some that we havent had available in the past. Moderna and others are working on RNA- and DNA-derived vaccines, which have the advantage of being potentially faster to develop, but the disadvantage of never having been all the way through human trials yet for anything. Its a field with a lot of promise, but it needs a lot of proof, too. This Stat article has some interesting info on synthetic biology approaches to a vaccine (nanoparticles, etc.), but those also remain unproven. It may well be that more tried-and-true vaccine development (immune response via proteins, rather than via DNA/RnA) blows all of these things from the landscape eventually, but for now Im glad to have a lot of approaches going on.

Past antibodies and vaccines we get to more exotic stuff like direct siRNA treatments, which Alnylam and others have announced work on. No disrespect to some good researchers and companies there, but I have these on a lower rung than the other possibilities. I dont see these things as having any shorter path to development than the more well-worked-out antibody and vaccine routes, and they have more uncertainties around them. Not least in dosing getting good systemic levels of something like an siRNA therapeutic is very much nontrivial. The oligonucleotide vaccine idea at least has the potential for a smaller dose needed, since its just trying to prime the immune system in general.

Ive no doubt missed some other approaches, and Ill update this post with more information as I have been doing for the small-molecule one. Final thoughts? I think that the biologic agents are likely to be the main line of defense against this coronavirus; there is every reason to believe that we can get an effective therapy out of one or more of these approaches. But none of them are going to be coming on in time to help the crisis were looking at right now. As I said before, look around you: we are fighting this epidemic with the tools we have on hand at the moment, and the chances of anything new and dramatic arriving shortly are very, very low. Months, many months, maybe a year or two, and thats if everything goes really, really well. Thats when the good stuff will be arriving.

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Covid-19 Biologic Therapies Reviewed - Science Magazine

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