StemCell Therapy

Scientists are tracking the SARS-CoV-2 virus that causes COVID-19 by sequencing the genome of virus samples collected from diagnostic testing. Using next generation sequencing on SARS-CoV-2 will help accurately diagnose the novel coronavirus, identify mutations and track its history.

A study by scientists at the UNC School of Medicine (Chapel Hill, NC, USA) has shown how next generation genetic sequencing can track mutations in the SARS-CoV-2 virus, which can in effect help with transmission tracing, diagnostic testing accuracy and vaccine effectiveness. This type of virus monitoring is also important in diagnostic testing. Much of the testing developed to diagnose COVID-19 looks for one portion of the gene sequence that causes the novel coronavirus. If that sequence mutates, the test is no longer accurate and results will be affected.

Their recent study is the largest to focus on suburban and rural communities in which the researchers were able to reconstruct the mutational landscape of cases seen at the UNC Medical Center. Within their study, the team of scientists did find variations in the virus genetic sequence, but fortunately none of the variations were located in the portion of the virus targeted in common diagnostic testing. 175 samples from confirmed COVID-19-positive patients were analyzed, out of which 57% carried the spike D614G variant noted in similar studies. The presence of this variant is associated with a higher genome copy number and its prevalence has expanded throughout the pandemic.

The researchers will continue using NGS to track the SARS-CoV-2 virus through the remainder of 2020. The goal is to enroll every patient at UNC Hospitals with flu or respiratory symptoms for COVID-19 diagnostic testing. These samples will be sequenced and compiled to form a comprehensive profile of any virus that these patients carry, information that will continue to help a community of researchers in their fight against SARS-CoV-2 and potentially novel coronaviruses.

We are concerned about future mutations though, said Dirk Dittmer, PhD, professor of microbiology and immunology at the UNC School of Medicine, and senior author of the study. It is inherent in a virus nature to mutate. Changes in other areas of the genetic sequence can not only disrupt testing, but hinder the effectiveness of vaccines.

Because we are only looking at one gene sequence for the virus, we have told the FDA that we will continually monitor for changes in this gene sequence so that we can be assured that our test is still reliable, said Melissa Miller, PhD, director of UNC Medical Center Microbiology and Molecular Microbiology Laboratories, and a co-author of the study. NGS will help us do that.

Related Links:UNC School of Medicine

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Use of Genetic Sequencing to Track SARS-CoV-2 Mutations Can Improve Diagnostic Testing Accuracy and Vaccine Effectiveness - HospiMedica

The American College of Medical Genetics currently recognizes a wide range of germline variants in the gene TP53 as pathogenic or likely pathogenic and causing the inherited disorder, Li-Fraumeni Syndrome.1 Cancers strongly associated with Li-Fraumeni syndrome include common and rare malignancies such as breast cancer, adrenocortical carcinoma, and osteosarcoma, and are normally diagnosed in patients at much younger ages than the average age of diagnosis for the general population.

In July 2020, a team of multidisciplinary researchers led by clinician-scientists at the Abramson Cancer Center at Penn Medicine, Philadelphia, added to the understanding of pathogenic TP53 variants with the publication of study in which they identified a rare, novel variant implicated in the development of Li-Fraumeni syndrome predominantly in families of Ashkenazi Jewish descent.2

Nonpathogenic p53 protein is composed of 4 major protein domains: transactivation, proline-rich, DNA-binding, and tetramerization, and is a transcription factor that activates transcription of genes encoding DNA repair machinery in healthy cells.1 Because p53 functions as a transcriptional regulator, pathogenic mutations in TP53 are most commonly observed in sequences encoding the DNA binding domain, causing the mutant p53 protein to lose its normal capacity to bind to target promoter sequences for transcriptional activation.1 Unlike more common pathogenic mutations in the DNA binding domain, the novel variant, c, 1000G>C;p. G334R, is a pathogenic missense mutation in the tetramerization domain of p53, resulting in disruption of the normal tetramerization of p53 polypeptides required to assume its native structure in wild-type carriers.2

A well-documented example of a pathogenic germline mutation in the tetramerization domain of p53 occurs in 0.3% of the general population in Southern Brazil, where a spectrum of early onset cancers was also observed in the population and confirmed as Li-Fraumeni Syndrome.3

Discovery of the novel pathogenic variant began with a research sequencing study at Abramsons Cancer Center aimed at identifying breast cancer susceptibility genes in patients with early-onset disease who were negative for germline pathogenic BRCA1/2 variants.4 Additional families with the TP53 c. 1000G>C; G334R variant were then identified from national databases and testing sites such as the National Society of Genetic Counselors ListServ and commercial genetic testing lab cases such as Ambry Genetics.

The researchers case-ascertainment database analyses resulted in a final total of 21 cases of early-onset cancer carrying the novel pathogenic TP53 variant.2 To further validate the pathogenicity of the novel variant, a team of multidisciplinary researchers utilized criteria in the 2015 ACMG/AMP Variant interpretation guidelines to evaluate predictive computational modeling of the mutant protein and in-vitro functional data of the mutant p53 in cells line.1,2

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Comprehensive Genomic Analysis in Some Patients With Breast Cancer Reveals Rare, Pathogenic TP53 Variant in Families of Ashkenazi Jewish Descent -...

At birth, Minette looked perfectly healthy, and her parents took their 7 pound, 9- ounce, brown-eyed baby girl home thinking all was well.

But her newborn screening test revealed something different.

The results indicated Minette had a rare lysosomal storage disease known as mucopolysaccharidosis type I, or MPS-1. Babies usually dont show any symptoms at birth, but the condition is progressively debilitating, eventually causing permanent damage to mental development, organ function and physical abilities.

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And at nine days old in January, 2019, after a series of tests run by the newborn screen follow up team in pediatric genetics at Michigan Medicine C.S. Mott Childrens Hospital, Minette was officially diagnosed with MPS-1.

There were no signs of this disease during pregnancy or after her birth, says her mother Samantha Mejia, of West Bloomfield, Mich.

It was so important that we identified it early so she could get treatment that would give her a better chance of living a more normal life.

MPS-1 means the body is missing or does not have enough of an enzyme needed to break down long chains of sugar molecules (glycosaminoglycans) within structures called lysosomes. Lysosomes are essentially the bodys recycling centers large molecules go in and come out small enough so the body can use them.

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When these molecules cant be broken down, they build up in the cell, causing many organs and tissues of the body to become enlarged, damaged and unable to work properly. Some children may develop mild to moderate mental impairment or learning difficulties, respiratory problems, sleep apnea and heart disease.

In severe cases like Minettes, children stop developing between ages 2-4, which is followed by progressive mental decline including loss of physical abilities and language skills.

MPS-1 was added to the Michigan newborn screen in August, 2017 just a little more than a year before Minette was born joining a list of more than 50 disorders that can now be detected through a simple blood test after birth.

Prior to being added to the newborn screen, many children were often diagnosed between ages one-and-a-half and three years old because they start losing developmental milestones or begin showing certain facial features as a result of glycosaminoglycans storage, such as thickened nostrils, lips or ears.

The clinical diagnosis of MPS-1 is often delayed because the symptoms tend to be non-specific early on. Newborn screening is crucial for making an early diagnosis and initiating treatment, which significantly alters the long term outcomes for patients, says Rachel Fisher, pediatric genetic counselor at Mott and a lysosomal storage disorder newborn screen coordinator for the state of Michigan.

Because of Minettes early diagnosis, her Mott care teams could quickly take next steps for treatment. She started enzyme therapy within six weeks, and at three months of age underwent four days of chemotherapy before ultimately getting a hematopoietic stem cell transplant to help replace the enzyme her body was missing.

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Baby Gets Early Stem Cell Transplant to Treat Rare Disease Thanks to Newborn Screening - University of Michigan Health System News

DUBLIN--(BUSINESS WIRE)--Oct 23, 2020--

The "Global Population Sequencing Market: Focus on Product, Method, Technology, Application, Country, and Competitive Landscape - Analysis and Forecast, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

The population sequencing market is projected to reach $64,047.6 million by 2030 from $21,730.4 million in 2020, at a CAGR of 11.41% during the forecast period, 2020-2030.

Growth in this market is expected to be driven by the rising adoption of large-scale sequencing to understand the genomics of susceptibility and resistance from COVID-19, increasing adoption of personalized medicine for the screening and diagnosis of genetic disorders, and a global surge in direct-to-consumer genetic testing.

However, there are significant challenges that are restraining the market growth, such as lack of infrastructure to maintain, store, and share sensitive genomic data, absence of sufficient funding for the development of high-throughput genomic software tools, and poor reducibility and transability of data in clinical practice.

The market is favored by the technological advancements in the sequencing, and computational analysis solutions for a large volume of genetic data enabling a deep understanding of the genetic variants for the development of diagnostics, drug discovery, and translational research.

Furthermore, several sequencing companies are focusing on the development of high-throughput sequence platforms and polymerase chain reaction platforms, with higher sensitivity and low turn-around time to benefit the patients, enabling patient-based outcomes and implementing genomic medicine.

Within the research report, the market is segmented on the basis of product type, application, methods, and technology. Each of these segments covers the snapshot of the market over the projected years, the inclination of the market revenue, underlying patterns, and trends by using analytics on the primary and secondary data obtained.

Competitive Landscape

The exponential rise in the application of precision medicine on the global level has created a buzz among companies to invest in the development of rapid diagnostics providing information on genetic mutation and optimal candidates for adjuvant chemotherapy or hormonal therapy. Due to the diverse product portfolio and intense market penetration, Illumina, Inc. has been a pioneer in this field and has been a significant competitor in this market.

The population sequencing market provided immense growth opportunities for the companies providing technology and infrastructure for large-scale health initiatives, such as Color Genomics, Inc., Helix Opco, LLC, and big data companies such as Genuity Science.

Key Questions Answered in this Report:

Key Topics Covered:

Executive Summary

1 Product Definition

1.1 Definition by Product

1.1.1 Platforms

1.1.2 Kits and Assays

1.1.3 Software Tools

1.2 Inclusion and Exclusion

1.2.1 Inclusion and Exclusion for Country-Wise Market Estimation

1.3 Scope of Work

1.4 Key Questions Answered in the Report

2 Research Methodology

3 Introduction

3.1 Market Overview

3.2 Impact of COVID-19 on Population Sequencing

3.3 Future Potential

4 Global Population Sequencing Market Dynamics

4.1 Overview

4.2 Impact Analysis

4.3 Market Drivers

4.3.1 Rising Adoption of Large-Scale Sequencing to Understand the Genomics of Susceptibility and Resistance from COVID-19

4.3.2 Increasing Adoption of Personalized Medicine for the Screening and Diagnostics of Genetic Disorders

4.3.3 Global Surge in Direct-to-Consumer (DTC) Genetic Testing

4.4 Market Restraints

4.4.1 Lack of Infrastructure to Maintain, Store and Share Sensitive Genomic Data

4.4.2 Absence of Sufficient Funding for Development of High-Throughput Genomic Software Tools

4.4.3 Poor Reducibility and Translatability of Data in Clinical Practice

4.5 Market Opportunity

4.5.1 Advancing Precision Medicine with Blockchain-Powered Artificial Intelligence

4.5.2 Technological Advancements in Sample Preparation for Population Sequencing

4.5.3 Increased Population Engagement and Data Management

5 Competitive Landscape

5.1 Key Strategies and Developments

5.1.1 Product Approval

5.1.2 Product Launches and Upgradations

5.1.3 Synergistic Activities

5.1.4 Funding and Expansion

5.1.5 Acquisitions

5.1.6 Other

6 Industry Insights

6.1 Overview

6.2 Legal Requirements and Framework in the U.S.

6.3 Legal Requirements and Framework in Europe

6.4 Legal Requirements and Framework in Asia-Pacific

6.4.1 Japan

6.5 Market Share Analysis (by Company) 2019

6.5.1 Growth Share Analysis (Opportunity Mapping)

6.5.2 By Company

7 Global Population Sequencing Initiatives (by Country)

8 Global Population Sequencing Market (by Product), $Million, 2019-2030

8.1 Introduction

8.2 Kits and Assays

8.3 Platforms

8.4 Software Tools

9 Global Population Sequencing Market (by Methods), $Million, 2019-2030

9.1 Introduction

9.2 Whole Genome Sequencing

9.3 Whole Exome Sequencing

9.4 Single-Read Sequencing

9.5 Other Sequencing Methods

10 Global Population Sequencing Market (by Technology), $Million, 2019-2030

10.1 Introduction

10.2 Polymerase Chain Reaction (PCR)

10.3 Next Generation Sequencing (NGS)

10.4 Other Technologies

11 Global Population Sequencing Market (by Application), $Million, 2019-2030

11.1 Introduction

11.2 Human health

11.2.1 Clinical Applications

11.2.1.1 Diagnostics

11.2.1.1.1 Cancer Diagnostics

11.2.1.1.2 Infectious Disease Diagnostics

11.2.1.1.3 Rare Disease Diagnostics

11.2.1.1.4 Other Diagnostics

11.2.1.2 Drug Discovery and Development

11.2.2 Translational Research Sequencing

11.3 Molecular Forensics

11.4 Blockchain in Genomics

11.4.1 Data Sharing and Monetization

11.4.2 Data Storage and Security

11.4.3 Automated Health Insurance

12 Global Population Sequencing Market (by Country), $Million, 2019-2030

13 Company Profiles

13.1 Company Overview

13.2 Role of Agilent Technologies, Inc. in Global Population Sequencing Market

13.3 Financials

13.4 Key Insights About Financial Health of the Company

13.5 SWOT Analysis

Originally posted here:
Global Population Sequencing Markets, 2020-2030 - Rising Adoption of Large-Scale Sequencing to Understand the Genomics of Susceptibility and...

CHAPEL HILL, N.C., Oct. 22, 2020 /PRNewswire/ -- In the largest study of its kind, researchers from the University of North Carolina at Chapel Hill (UNC) have discovered a genetic variant that can be used to predict if patients will develop hypertension from the widely used cancer drug Avastin (generic name bevacizumab). The groundbreaking work is being presented this weekend by the lead researcher, Dr. Federico Innocenti, during a plenary session at the 32nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. The presentation can be viewed on Sunday, October 25th at 9:45 ET on the Conference website.

VEGF inhibitors like Avastin have revolutionized cancer treatment and have been used by millions of patients. Because they target blood vessel growth and regulation, the most common and severe side effects are usually cardiovascular-related. Currently, there is no way to predict who is likely to experience these serious and potentially fatal adverse events, which can develop quickly and often require stopping or modifying treatment.

After analyzing thousands of genomic variations from over 1,000 Caucasian cancer patients across five independent clinical trials the researchers identified a genomic variant that appears twice as often in patients with hypertension than without it, and is present in over a quarter of hypertension cases. These results suggest the return on testing for this variant is very high. When assessing how many people need to be tested to avoid one severe event, the number is only 34 for Caucasian patients. If confirmed in patients of African ancestry, the number drops to just 9, given the much higher occurrence of the variant (80%+) in this population.

William R. Sellers,Professor of Medicine at the Dana-Farber Cancer Institute, who is co-chairof the Conference and not involved with the research said, "Side effects from bevacizumab can be debilitating; a simple genetic test to identify which patients will experience toxicities could help provide better and more effective treatments for our patients." Dr. Federico Innocenti, Associate Professor at UNC who led the research added, "Early identification is a potential double win. It will first help doctors identify patients at a higher risk of hypertension induced by Avastin. Then, for example, these patients can receive closer monitoring or prophylactic treatment, allowing them to continue their cancer treatment uninterrupted."

With support from the research group Emerald Lake Safety, efforts are currently underway to start a prospective study that will provide doctors with a free test to screen patients and update their treatment regimens as necessary. "Interested clinicians should contact me," says Dr. Innocenti.

Press Contact:

FedericoInnocenti, MD, PhD[emailprotected](949) 257-2074

SOURCE Federico Innocenti, MD, PhD

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UNC Researchers Identify Genetic Variant Linked to Drug-Induced Hypertension with Avastin - PRNewswire

The cause of fragile X syndrome (FXS), the most common inherited intellectual disability, is easy to see in the lab. Under electron microscopy, an affected X chromosome exhibits a deformed tip that gives the disorder its name and pinpoints the causative gene malfunction. Theres no cure for the disease, whose symptoms include learning deficits and hyperactivity and which has been linked with autism. FXS occurs in 1 in 4,000 to 7,000 males and 1 in 8,000 to 11,000 females in the United States.

Most research on FXS has focused on the brains neurons, the cells that transmit electrical and chemical impulses. But for a decade Yongjie Yang, associate professor of neuroscience at Tufts University School of Medicine, has pursued a different path, investigating the involvement of glia cells, particularly astroglia, which support neuron function and make up more than half the brain. In the past month, hes published in the Proceedings of the National Academy of Sciences (PNAS) and Glia. Tufts Now spoke with Yang about his work.

Tufts Now: What do we know about FXS?

Yongjie Yang: Fragile X syndrome is caused by the mutation of a single gene, FMR1, that codes for the FMRP protein, which is found in all brain cells and is essential for normal cognitive development. The mutation doesnt actually change the genetic code. Instead it causes part of the gene, specifically the chemical bases CGG, to repeat. We all carry those repeats in different numbers. If you carry roughly 50 or fewer, your brain development will be normal, but if the repeats go beyond 200, you will have the full mutation and your brain will produce only 10 to 20 percent of the needed level of FMRP, especially if youre male. FXS was characterized in 1943 but the genetic mutation wasnt identified until 1991, almost half a century a later.

What is the relationship between autism spectrum disorder (ASD) and FXS?

The two are intermingled. ASD is much more common, occurring in 1 in 54 children according to new estimates. Its believed that 1 to 6 percent of people with ASD have the FXS mutation, and that mutation accounts for the largest genetic subset of those with ASD. Many people with FXS are also autistic. FXS is a learning and intellectual disability, while ASD includes a wide range of social and communications challenges.

What are the key findings of your most recent research?

The study in Glia shows that some physical symptoms of FXS can be induced in mice by eliminating FMRP from astroglia alone. So in thinking about gene therapy for FXS, we need to consider glia cells, not just neurons. Our PNAS paper is exciting because it defines a unique, distinct FMRP-dependent pathway in mouse and human astroglia that regulates communications from astroglia to neurons through mGluR5, an important receptor for glutamate, the neurotransmitter that triggers brain activity. Interestingly, this regulation pathway isnt found in neurons. Its also the first study to demonstrate how overall protein expression is changed in FMR1-deficient astroglia. Unveiling astroglia-specific molecular mechanisms involved in FXS development could give us new targets for potential therapeutics.

Whats next?

We want to better understand the pathophysiology of FXS and identify new avenues for drugs and other interventions to attenuate the effects of the disease. Of course gene therapy would be wonderful but it often takes a long, long time and carries a lot of risk. Most other studies have focused on the neuron side, and drug trials based on these studies have failed so far. Our glia/astroglia perspective gives a fresh view to search for new targets.

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Getting to the Roots of Fragile X Syndrome - Tufts Now

Two medical students at Weill Cornell Medicine-Qatar (WCM-Q) have conducted a systematic review of the latest medical literature to provide a clearer understanding of how the novel coronavirus affects pregnant women, new mothers and newborn babies.

Second-year students Reem Chamseddine and Farah Wahbeh reviewed 245 pregnancies that were complicated by maternal SARS-CoV-2 infection across 48 scientific studies published between the emergence of the pandemic in December 2019 and July 30, 2020. They found that 55.9 percent of the pregnant women with SARS-CoV-2 infection presented with fever and 36.3 percent with a cough. A total of 12.7 percent presented with shortness of breath, but only 4.1 percent developed respiratory distress.

The vast majority (89 percent) of the pregnant women with SARS-CoV-2 delivered their babies via cesarean section, compared with 15 percent in the general population, the study noted. Out of 201 newborns reported in the literature, 35.3 percent of babies born to mothers with SARS-CoV-2 were delivered pre-term (before 36 weeks), compared with 13 percent in the general population. There was a concerning 2.5 percent rate of stillbirth delivery or neonatal death, compared with less than one percent in the general population. However, the study indicated that the risk of death for pregnant women with SARS-CoV-2 is low, and that it does not appear that the infection is vertically transmitted from mother to fetus during pregnancy, although 6.45 percent of newborns tested positive for the disease. It is possible these newborns acquired SARS-CoV-2 infection in the hospital or at home after birth, according to the literature.

The study also found that SARS-CoV-2 does not appear to be passed from mother to baby in breast milk, but that there is still a risk the infection can be passed on via respiratory droplets during breastfeeding. As such, SARS-CoV-2-positive mothers are advised to take reasonable precautions during breastfeeding.

The study, titled Pregnancy and Neonatal Outcomes in SARS-CoV-2 Infection: A Systematic Review, has been published in theJournal of Pregnancy, a leading peer-reviewed open-access journal.

Student Reem Chamseddine, a member of WCM-Qs Class of 2023, said: In the early days of the pandemic, not much was known regarding pregnancy complications in the setting of SARS-CoV-2 infection. Naturally, it was important to understand the emerging data about this topic as the virus would affect thousands of pregnant women. As medical students, we are encouraged to be curious and to engage in the healthcare issues around us. Getting to work on this project is an example of the academic values instilled in us here at WCM-Q.

Farah Wahbeh, also a member of the Class of 2023, said: The role of a medical student does not stop at learning how to diagnose and treat medical conditions; it is also our responsibility to take action during such uncertain times and to contribute in every way we can. This experience has been unique given the urgency and time sensitivity associated with the project. It taught us valuable skills and embodied our role as active contributors to the scientific community.

Reem and Farah were mentored during the research process by Dr. Arash Rafii Tabrizi, Professor of Genetic Medicine in Obstetrics and Gynecology at WCM-Q, who is also a named author of the research paper.

Dr. Tabrizi, who is also Director of the Clinical Research Support Core at WCM-Q, said: I was really impressed by the desire of our students to be part of the fight against COVID-19. In the early stages of the emergence of a new virus and a new disease there is a tremendous fear of the unknown and therefore an urgent need for evidence-based information. As such, the work of Reem and Farah perfectly illustrates one of the most important elements of our mission as doctors: we have to provide accurate information to allow people to adopt the correct attitude and actions to protect themselves and others.

He added: The work was difficult as new information was coming in almost every day and Reem and Farah had to filter and organize it correctly. The final result is a great review that really illustrates the impact of COVID-19 on the pregnant women as well as their newborn babies.

The review can be read in full here:https://www.hindawi.com/journals/jp/2020/4592450/

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WCM-Q Student Researchers Probe Effects of COVID-19 on Pregnancy - Al-Bawaba

Dr Robert Nagourneyis the founder and medical director of Nagourney Cancer Institute, and clinical professor at the University of California, Irvine School of Medicine. Nagourney is having success investigating whether a unique combination of existing and approved cancer drugs might be more effective compared to off-the-shelf treatments. Technology Networks recently had the pleasure of speaking with Nagourney to learn more about his work focused on repurposing drugs. He discusses the challenges and benefits of exploring new uses for drugs that are outside the scope of their original indication. He also shares a case whereby a cancer patient was recently treated with a tailored drug combination and explains how it was possible to design an effective personalized treatment strategy.Laura Lansdowne (LL): Can you touch on the importance of physiological relevance when testing therapeutics inin vitrosystems, has there been any key advances in cell culture technologies that have been particularly effective at improving this?Robert Nagourney (RN): The wide use of genomic profiling by next-generation sequencing (NGS) has provided targetable mutations in a number of cancers including chronic myeloid leukemia (CML), several forms of lung cancer, kidney cancersand melanoma. However, the majority of human tumors do not reveal actionable mutations. Today these tumors are treated with cytotoxic chemotherapy or experimental drugs with no attempt to select among options and offer combinations that are patient specific. To address patients needs we developed the Ex Vivo Analysis of Programmed Cell Death or EVA/PCD platform.Two fundamental advances have led to the successful application of our EVA/PCD technology for the prediction of patient response over older technologies.

LL: Could you tell us more about your work repurposing drugs?RN: Drugs do not know what diseases they were invented for. This not only applies to drugs for cancer but to other drugs with biological effect that can influence cancer cell behavior.LL: In yourblogyoushare the story of a Stage 4 gastroesophageal cancer patient that was recently treated with a tailored drug combination. Could you elaborate on the genetic clue that helped design an effective combination therapy?RN: The patient was found sensitive to a drug that targets EGFR a cell signaling pathway. However,he did not have a mutation in EGFR. As such his doctors did not anticipate a likelihood of benefit from drugs that target EGFR and did not offer him these agents. In our EVA/PCD we found activity for these drugs. When we reviewed his gene profile it showed an EGFR amplification (not a mutation). Since EGFR amplificationis not considered a target, no drug was offered but with thediscriminating (functional) capability of the EVA/PCD assay, he indeed was that rare person with an EGFR amplification who would actually likely respond and when we gave it to him he did Completely!LL: When repurposing a drug, how careful do we need to be when considering existing safety and efficacy data? E.g. data that were obtained in previous studies, fordifferentindications, in adifferentstudy population (age/sex/ethnicity, etc.).RN: Any novel combination runs some risk, but many repurposed drugs are already in wide use, and very often are used in combination with many other drugs. I am not a proponent of random combinations (however many commercial firms do offer them) but instead like to examine the patient's likelihood of benefit when we do suggest a drug or combination.LL: What measures/approaches should be taken when considering off-label use of a drug?RN: Usually these drugs are well known for their modes of action and toxicity. The literature provides ample information on drugdrug interactions and usually can be consulted if an unusual combination is being considered.LL: There is currently no regulatory requirement to know the molecular target of a drug, as long the drug is shown to be safe and efficacious. How much of a drawback does this gap in knowledge present, in terms of repurposing existing drugs for other indications?RN: Actually, many new drugs come with companion diagnostics. That is, you can only get a TRK inhibitor if you are shown to carry and NTRK fusion. Where functional platforms can be immensely helpful is the vast amount of genomic regulation and cellular gene activity that cannot be identified at a genetic level.One perfect example in the oncogene MYC. This super-regulator that functions epigenetically is abnormally active in up to 70% of cancers, it regulates over 3600 individual human genes (15% of the human genome) and isalmost never mutated ever. Thus, it is only by probing its activities at a functional level that you know to target it therapeutically. Gene profiles are useless.Robert Nagourney was speaking with Laura Elizabeth Lansdowne, Senior Science Writer for Technology Networks.Interviewee BiographyDr Nagourney is a native of Connecticut and a graduate of McGill University School of Medicine and became disenchanted with the trial and error approach that he witnessed during fellowships at Georgetown and The Scripps Institute.Nagourney is currently a practicing oncologist and triple board certified in Internal Medicine, Medical Oncology and Hematology. Among his many accomplishments, as co-investigator on national cooperative trials. He is recognized for the introduction of Cisplatin/Gemcitabine doublets in the treatment of advanced ovarian and breast cancers.With more than 20 years of experience in human tumor primary culture analyses, Dr Nagourney has authored more than 100 manuscripts, book chapters and abstracts including publications in the Journal of Clinical Oncology, Gynecologic Oncology, the Journal of the National Cancer Institute and British Journal of Cancer.

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Repurposing and Combining Drugs An Effective Cancer Treatment Strategy - Technology Networks

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today positive results from the 6-month primary analysis of the ILLUMINATE-B Phase 3 pediatric study of lumasiran, an investigational, subcutaneously administered RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) the gene encoding glycolate oxidase (GO) in development for the treatment of adults and children with primary hyperoxaluria type 1 (PH1). Results were presented from ILLUMINATE-B, as well as new 12-month results from the ILLUMINATE-A pivotal Phase 3 study and the ongoing Phase 2 open-label extension (OLE) study, at the American Society of Nephrology (ASN) Kidney Week 2020 held as a virtual event on October 22-25.

Lumasiran is under review by the Food and Drug Administration (FDA) and received a Positive Opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 16, 2020. If approved, lumasiran will be marketed as OXLUMOTM.

We are delighted to present these positive data from ILLUMINATE-B that reinforce previously reported clinical study findings for lumasiran and underscore its potential to be an important treatment option for patients of all ages with PH1, a devastating and potentially fatal disease with no approved pharmaceutical treatment options, said Pritesh J. Gandhi, PharmD., Vice President and General Manager, Lumasiran Program at Alnylam. Based on longer term follow-up from the ILLUMINATE-A and Phase 2 open-label extension studies, investigators presented data showing enduring reductions of urinary oxalate the disease-causing metabolite in PH1. Moreover, we believe that newly presented results of exploratory endpoints provide preliminary evidence that reductions in urinary oxalate may lead to reduced rates of renal stone events and improve nephrocalcinosis in some patients.

Pathologic overproduction of oxalate by the liver is the root cause of morbidity and mortality associated with PH1. There is strong evidence in the literature to suggest that levels of urinary oxalate correlate with clinical outcomes in patients with this ultra-rare disease. With that in mind, I am pleased to see the reduction in urinary oxalate levels in response to lumasiran in all three studies presented at this years meeting. More broadly, I am encouraged by the promise that these findings hold for my patients living with this condition, said Jeffrey M. Saland, M.D., Professor and Chief, Pediatric Nephrology and Hypertension, Jack and Lucy Clark Department of Pediatrics, Mount Sinai Kravis Childrens Hospital, New York City, and Investigator on the ILLUMINATE-A trial. With the sustained reductions in urinary oxalate during long-term treatment and the exploratory renal stone and nephrocalcinosis data presented, I am hopeful about the potential of lumasiran to have a positive impact on the severe clinical manifestations that individuals with PH1 suffer.

ILLUMINATE-B 6-Month Results

Alnylam presented positive efficacy and safety results from the 6-month primary analysis (N=18) of the ILLUMINATE-B Phase 3 study of lumasiran in infants and children under the age of 6, with the youngest patient enrolled at 3 months of age. The efficacy results and safety profile of lumasiran were found to be similar to those observed in adults and children 6 years or older in the ILLUMINATE-A study. Treatment with lumasiran in ILLUMINATE-B led to a 72 percent mean reduction in spot urinary oxalate:creatinine ratio from baseline to Month 6, averaged across months 3 to 6 the primary endpoint of the study. Lumasiran also demonstrated positive results across secondary endpoints, including proportion of patients (9/18 or 50 percent) achieving urinary oxalate levels at or below 1.5 times ULNa.

Preliminary analysis of exploratory endpoints indicated improvements in nephrocalcinosis in 8 out of 18 patients (44 percent), while estimated glomerular filtration rates (eGFR) remained stable. At baseline, 14 of 18 patients had nephrocalcinosis. After 6 months of lumasiran treatment, no patients worsened, 10 remained stable, and eight showed bilateral (3 out of 8) or unilateral (5 out of 8) improvements in nephrocalcinosis. As expected, given the 6-month duration of the study, there was no change in the rate of renal stone events (RSEs)b .

Lumasiran had an acceptable safety profile in infants and young children under the age of six. There were no deaths, severe adverse events, discontinuations of treatment or withdrawals from the study. One patient had a serious adverse event (SAE) of viral infection that was considered not related to lumasiran by the study investigator. The most common drug-related adverse events (AEs) were mild and transient injection site reactions (ISRs) reported in 3 of 18 (17 percent) patients. No clinically relevant changes in laboratory measures (including liver function tests), vital signs, or electrocardiograms related to lumasiran were observed.

ILLUMINATE-A 12-Month Results

As of the data cut-off date of May 1, 2020, results from the extension period of the ILLUMINATE-A Phase 3 study showed that patients initially randomized to lumasiran in the 6-month double-blind (DB) period who continued treatment with lumasiran through Month 12 (lumasiran/lumasiran; N=24) maintained their reduction in 24-hour urinary oxalate excretion, with a 64 percent mean reduction relative to baseline. The majority (88 percent) of patients in this group reached normal or near-normal levels (at or below 1.5x ULN)a of urinary oxalate. In patients who were originally randomized to placebo in the DB period but crossed over to lumasiran (placebo/lumasiran; N=13), treatment with lumasiran led to a 57 percent mean reduction in 24-hour urinary oxalate excretion after six months of treatment; 77 percent of these patients reached urinary oxalate levels at or below 1.5 x ULN.

In an exploratory analysis, reductions in oxalate levels were associated with lower rates of RSEb in lumasiran treated patients in both lumasiran/lumasiran and placebo/lumasiran groups.

The safety profile of lumasiran remained consistent with ongoing dosing (233 doses) and 9.9 months of mean exposure (range 2.8-15.1 months). There were no deaths, SAEs, treatment interruptions or discontinuations related to lumasiran. One patient had an SAE of urosepsis that was not related to study drug. Mild ISRs were the most common drug-related AE reported in at least 10 percent of patients. Most common ISR symptoms included erythema, pain, pruritus, or swelling at the injection site. No clinically relevant changes in laboratory measures (including liver function tests), vital signs, and electrocardiograms related to lumasiran were observed.

Phase 2 OLE Results

Additional positive data were also presented from the ongoing Phase 2 OLE study of lumasiran demonstrating the long-term efficacy and safety of lumasiran with up to 22 months of exposure (range: 11-22 months; median: 15 months). As of January 30, 2020, data cut-off date, patients continued to experience sustained reductions in urinary oxalate excretion, with similar responses across dosage regimens. Specifically, ongoing treatment with lumasiran resulted in 74 percent (range: 35.788.3 percent) mean maximal reduction in urinary oxalate relative to Phase 1/2 baseline (N=17), and 17/18 (94 percent) of patients achieved normal or near-normal levels of urinary oxalate. Mean eGFR levels remained stable over time.

Lumasiran had an acceptable safety profile. There were no deaths, severe AEs, or AEs leading to discontinuation of treatment. There were no drug-related SAEs. The most common drug-related AEs were mild ISRs. No clinically significant laboratory changes related to lumasiran were reported.

Post-hoc analysis of renal stones showed that long-term treatment with lumasiran resulted in a decline in the number of patients experiencing renal stones. In the 12 months prior to study entry, 6/20 patients (30 percent) reported renal stones. In the Phase 1/2 Part B study where renal stones were captured as AEs, 4/20 patients (20 percent) reported AEs of renal stones during the initial 5-month period, and no patients (0/20) reported AEs of renal stones during the Phase 2 OLE with up to 22 months of treatment.

Additional findings on real-world disease manifestations and healthcare resource use among patients with PH1 were also presented based on a retrospective multinational study of physician chart reviews.

To view all data presented by Alnylam at ASN Kidney Week, please visit http://www.alnylam.com/capella.

Lumasiran has received U.S. and EU Orphan Drug Designations, Breakthrough Therapy and Rare Pediatric Disease Designations from the FDA, and a Priority Medicines (PRIME) designation from the EMA. Alnylam has filed a New Drug Application (NDA) for lumasiran with the FDA, which has granted a Priority Review for the NDA and has set an action date of December 3, 2020 under the Prescription Drug User Fee Act (PDUFA). Following the recent Positive Opinion from the CHMP, the Company plans to initiate commercialization of lumasiran in the EU under the tradename OXLUMO, upon marketing authorization from the European Commission.

The Company is also conducting ILLUMINATE-C a global open-label Phase 3 study of lumasiran in PH1 patients of all ages with advanced renal disease, including patients on dialysis, with topline results expected in 2021.

a Upper limit of normal or ULN = 0.514 mmol/24 hr/1.73m2; 1.5 x ULN = 0.771 mmol/24 hr/1.73 m2b A renal stone event (RSE) is defined as an event that includes at least one of the following: visit to healthcare provider because of a renal stone, medication for renal colic, stone passage, or macroscopic hematuria due to a renal stone

About ILLUMINATE-A Phase 3 Study

ILLUMINATE-A (NCT03681184) is a six-month randomized, double-blind, placebo-controlled, global, multicenter Phase 3 study (with a 54-month extension period) to evaluate the efficacy and safety of lumasiran in 39 patients, age six and older, with a documented diagnosis of PH1. Patients were randomized 2:1 to receive three monthly doses of lumasiran or placebo followed by quarterly doses at 3 mg/kg. The primary endpoint was the percent change in 24-hour urinary oxalate excretion from baseline to the average of months 3 to 6 in the patients treated with lumasiran as compared to placebo. Treatment arms were stratified at randomization based upon mean 24-hour urinary oxalate during screening (1.7 or >1.7 mmol/24hr/1.73m2). Key secondary and exploratory endpoints were designed to evaluate additional measures of urinary oxalate, plasma oxalate, estimated glomerular filtration rate (eGFR), nephrocalcinosis, renal stone events, safety and tolerability.

About ILLUMINATE-B Phase 3 Study

ILLUMINATE-B (NCT03905694) is a single arm, open-label, multicenter Phase 3 trial to evaluate the efficacy and safety of lumasiran in 18 patients with PH1 under the age of six (range: 3-72 months), with an estimated glomerular filtration rate (eGFR) of greater than 45 mL/min/1.73 m2 or normal serum creatinine if less than 12 months old, at nine study sites, in five countries around the world. Lumasiran was administered according to a weight-based dosing regimen. The primary efficacy endpoint of the study was the percent change from baseline to Month 6 in spot urinary oxalate:creatinine ratio averaged across Months 3 to 6. At six months, relative to baseline, lumasiran demonstrated a clinically meaningful reduction in spot urinary oxalate:creatinine ratio. Reduction of urinary oxalate relative to baseline was consistent across all three body weight categories (less than 10 kg; 10 kg to less than 20 kg, and 20 kg or higher).

About Lumasiran

Lumasiran is an investigational, subcutaneously administered RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) in development for the treatment of primary hyperoxaluria type 1 (PH1). HAO1 encodes glycolate oxidase (GO). Thus, by silencing HAO1 and depleting the GO enzyme, lumasiran inhibits production of oxalate the metabolite that directly contributes to the pathophysiology of PH1. Lumasiran utilizes Alnylam's Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate technology, which enables subcutaneous dosing with increased potency and durability and a wide therapeutic index. Lumasiran has received both U.S. and EU Orphan Drug Designations, Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA). Lumasiran is under review by the U.S. FDA and received a Positive Opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMA.

About Primary Hyperoxaluria Type 1 (PH1)

PH1 is an ultra-rare disease in which excessive oxalate production results in the deposition of calcium oxalate crystals in the kidneys and urinary tract and can lead to the formation of painful and recurrent kidney stones and nephrocalcinosis. Renal damage is caused by a combination of tubular toxicity from oxalate, calcium oxalate deposition in the kidneys, and urinary obstruction by calcium oxalate stones. Compromised kidney function exacerbates the disease as the excess oxalate can no longer be effectively excreted, resulting in subsequent accumulation and crystallization in bones, eyes, skin, and heart, leading to severe illness and death. Current treatment options are very limited and include frequent renal dialysis or combined organ transplantation of liver and kidney, a procedure with high morbidity that is limited due to organ availability. Although a small minority of patients respond to vitamin B6 therapy, there are no approved pharmaceutical therapies for PH1.

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as a major scientific breakthrough that happens once every decade or so, and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines, known as RNAi therapeutics, is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, function upstream of todays medicines by potently silencing messenger RNA (mRNA) the genetic precursors that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam

Alnylam (Nasdaq: ALNY) is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare genetic, cardio-metabolic, hepatic infectious, and central nervous system (CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach for the treatment of a wide range of severe and debilitating diseases. Founded in 2002, Alnylam is delivering on a bold vision to turn scientific possibility into reality, with a robust RNAi therapeutics platform. Alnylams commercial RNAi therapeutic products are ONPATTRO (patisiran), approved in the U.S., EU, Canada, Japan, Brazil, and Switzerland, and GIVLAARI (givosiran), approved in the U.S, EU, and Brazil. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its Alnylam 2020 strategy of building a multi-product, commercial-stage biopharmaceutical company with a sustainable pipeline of RNAi-based medicines to address the needs of patients who have limited or inadequate treatment options. Alnylam is headquartered in Cambridge, MA. For more information about our people, science and pipeline, please visit http://www.alnylam.com and engage with us on Twitter at @Alnylam or on LinkedIn.

Alnylam Forward Looking Statements

Various statements in this release concerning Alnylam's future expectations, plans and prospects, including, without limitation, Alnylams views with respect to the safety and efficacy of lumasiran as demonstrated in the ILLUMINATE-B Phase 3 study in children under the age of six, including infants, as well as in the 12-Month extension period of the ILLUMINATE-A pivotal study and in results from the ongoing Phase 2 OLE study, the potential for lumasiran to have a favorable impact on PH1 disease manifestations and overall disease progression and management across all ages, Alnylam's expectations with respect to the review timelines for the lumasiran NDA by the FDA and expectations regarding EMA approval following the Positive Opinion from the CHMP, Alnylams plans, assuming favorable regulatory reviews, to bring lumasiran to patients with PH1 around the world under the tradename OXLUMO, expectations regarding the timing of topline results from ILLUMINATE-C, and expectations regarding the continued execution on its Alnylam 2020 guidance for the advancement and commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation: the direct or indirect impact of the COVID-19 global pandemic or any future pandemic, such as the scope and duration of the outbreak, government actions and restrictive measures implemented in response, material delays in diagnoses of rare diseases, initiation or continuation of treatment for diseases addressed by Alnylam products, or in patient enrollment in clinical trials, potential supply chain disruptions, and other potential impacts to Alnylams business, the effectiveness or timeliness of steps taken by Alnylam to mitigate the impact of the pandemic, and Alnylams ability to execute business continuity plans to address disruptions caused by the COVID-19 or any future pandemic; Alnylam's ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for its product candidates, including lumasiran, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates for a specified indication or at all; actions or advice of regulatory agencies, which may affect the design, initiation, timing, continuation and/or progress of clinical trials or result in the need for additional pre-clinical and/or clinical testing; delays, interruptions or failures in the manufacture and supply of its product candidates, including lumasiran, or its marketed products; obtaining, maintaining and protecting intellectual property; intellectual property matters including potential patent litigation relating to its platform, products or product candidates; obtaining regulatory approval for its product candidates, including lumasiran, and maintaining regulatory approval and obtaining pricing and reimbursement for its products, including ONPATTRO and GIVLAARI; progress in continuing to establish a commercial and ex-United States infrastructure; successfully launching, marketing and selling its approved products globally, including ONPATTRO and GIVLAARI, and achieving net product revenues for ONPATTRO within its revised expected range during 2020; Alnylams ability to successfully expand the indication for ONPATTRO in the future; competition from others using technology similar to Alnylam's and others developing products for similar uses; Alnylam's ability to manage its growth and operating expenses within the ranges of guidance provided by Alnylam through the implementation of further discipline in operations to moderate spend and its ability to achieve a self-sustainable financial profile in the future without the need for future equity financing; Alnylams ability to establish and maintain strategic business alliances and new business initiatives; Alnylam's dependence on third parties, including Regeneron, for development, manufacture and distribution of certain products, including eye and CNS products, Ironwood, for assistance with the education about and promotion of GIVLAARI, and Vir for the development of ALN-COV and other potential RNAi therapeutics targeting SARS-CoV-2 and host factors for SARS-CoV-2; the outcome of litigation; the risk of government investigations; and unexpected expenditures; as well as those risks more fully discussed in the "Risk Factors" filed with Alnylam's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam's views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

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Alnylam Presents Positive Results from ILLUMINATE-B Phase 3 Study in Pediatric Patients with Primary Hyperoxaluria Type 1 at the American Society of...

LA JOLLA, Calif., Oct. 22, 2020 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it plans to initiate a multi-center, placebo-controlled, randomized Phase 2b trial to evaluate MN-166 (ibudilast) in chemotherapy-induced peripheral neuropathy (CIPN).

The clinical trial is a collaborative effort between MediciNova, the University of Sydney, and the Australasian Gastro-Intestinal Trials Group (AGITG). Dr. Janette Vardy, Professor of Cancer Medicine, University of Sydney in Australia, will be the lead principal investigator. The proposed clinical trial will evaluate MN-166 (ibudilast) as a potential treatment to reduce acute neurotoxicity severity and CIPN in patients with metastatic colorectal cancer. AGITG will provide funding for this study and MediciNova will provide study drug and regulatory support.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc. commented, We are excited to collaborate with Dr. Vardy on this grant-funded study to further explore the potential of MN-166 as a pharmacotherapy for CIPN. As we recently reported, our first clinical trial in CIPN showed that half of participants reported improved symptoms in the acute period and showed improved neurological parameters on clinical assessment with ibudilast treatment. There is a large unmet medical need for patients with this disorder.

Dr. Janette Vardy, the Principal Investigator for this study, commented, The findings from our initial study were encouraging, and with the support of AGITG and MediciNova, we plan to explore further the potential clinical utility of ibudilast in a larger sample of patients who experience oxaliplatin-induced acute neurotoxicity and chronic CIPN.

About the Chemotherapy-induced Peripheral Neuropathy Trial

This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial to determine whether MN-166 (ibudilast) can decrease acute neurotoxicity symptoms and CIPN, and to determine whether ibudilast treatment results in fewer neurotoxicity-induced dose reductions in patients with metastatic colorectal cancer receiving oxaliplatin up to six months. We plan to enroll a total 100 patients in a 1:1 (ibudilast:placebo) ratio. Treatment (MN-166 (ibudilast) 60 mg/day or matching placebo) will commence two days prior to the first cycle of oxaliplatin chemotherapy and will continue for the duration of the oxaliplatin chemotherapy.

About Chemotherapy-induced Peripheral Neuropathy

Peripheral neuropathy is a set of symptoms caused by damage to the nerves that are outside of the brain and spinal cord. These distant nerves are called peripheral nerves. Some of the chemotherapy and other drugs used to treat cancer can damage peripheral nerves that carry sensations to the hands and feet. This damage results in chemotherapy-induced peripheral neuropathy (CIPN) and is a common side effect of cancer chemotherapy. Most commonly, people complain of pins and needles in their toes and fingers. CIPN may affect cancer outcomes due to reductions in chemotherapy dosing and/or premature treatment discontinuation and have a profound impact on quality of life and survivorship. According to a meta-analysis which included more than 4,000 patients, CIPN prevalence was 68% when measured in the first month after chemotherapy, 60% at 3 months, and 30% at 6 months or more (Seretny et al., 2014). Long-term neurotoxicity is an important issue for the growing number of cancer survivors, with the highest number of affected patients having been treated for breast and/or colon cancer.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. Our earlier human studies demonstrated significant reductions of serum MIF level after treatment with MN-166 (ibudilast). It also attenuates activated glial cells, which play a major role in certain neurological conditions. MN-166 (ibudilast)'s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical studies, which provide the rationale for treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (MS) and other neurological diseases such as glioblastoma (GBM), and substance abuse/addiction. MediciNova is developing MN-166 for ALS, progressive MS and other neurological conditions such as degenerative cervical myelopathy (DCM), glioblastoma, substance abuse/addiction, and chemotherapy-induced peripheral neuropathy, as well as prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19. MediciNova has a portfolio of patents which covers the use of MN-166 (ibudilast) to treat various diseases including ALS, progressive MS, and drug addiction.

About MediciNova

MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a primary commercial focus on the U.S. market. MediciNova's current strategy is to focus on BC-PIV SARS-COV-2 vaccine for COVID-19, MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), degenerative cervical myelopathy (DCM), substance dependence (e.g., alcohol use disorder, methamphetamine dependence, opioid dependence) and glioblastoma (GBM), as well as prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19, and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). MediciNovas pipeline also includes MN-221 (bedoradrine) and MN-029 (denibulin). For more information on MediciNova, Inc., please visit http://www.medicinova.com.

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of BC-PIV SARS-COV-2 vaccine, MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," considering, planning or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of BC-PIV SARS-COV-2 vaccine, MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2019 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

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MediciNova, in Collaboration with the University of Sydney and the Australasian Gastro-Intestinal Trials Group, Announces Plans for a Multi-center,...

Market Report Summary

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Reaching the revenues of over US$ 6 Bn at the end of 2019, the globalneuropathic pain management marketis projected for a healthy CAGR during the forecast period (2019 2029). Increasing prevalence of neuropathic pain disorders and growing awareness about pain medication are boosting the demand for pain management drugs.

Pipeline strategies by manufacturers are focused on introducing advanced drugs with minimum side effects to increase market share. For instance, Pfizer sponsored drug Pregabalin, effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma that is in phase 3 clinical trials. Increasing research and development activities to develop medications for indications such as post-herpetic neuralgia are creating significant opportunities for manufactures to flourish in the market.

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Key Takeaways Neuropathic Pain Management Market Study

Increasing prevalence of diabetic neuropathy and availability of approved neuropathy pain medications have significantly added to the opportunities for market growth, thereby fostering the rate of adoption of neuropathic pain management drugs.

Increasing R&D Spending by Pharmaceuticals Companies Shaping Future

One of the key factors observed to impact the neuropathic pain management market growth is the development of new drugs for treatment of neuropathic and chronic pains. Companies are focusing on clinical trials to develop drugs for efficient treatment of neuropathic pain. For instance, Eli Lilly and Company developed Duloxetine (LY248686) for Diabetic Peripheral Neuropathic Pain (DPNP) that is under phase 4 clinical trial.

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At the same time, companies are focused on expanding therapeutic applications of drugs such as opioids and steroids for neuropathic pain management without causing any serious side effects to patients. Currently, more than 100 clinical trials are been carried out for pain management. Among those clinical trials, nearly half of the clinical trials are for various indications of neuropathic pain such as diabetic neuropathy and post-herpetic neuralgia.

What Does the Report Cover?

The neuropathic pain management market, a new study from Persistence Market Research, provides unparalleled insights on evolution of the neuropathic pain management market during 2014 2018 and presents demand projections during 2019 2029 on the basis of drug class (tricyclic anti-depressants, anticonvulsants, SNRIs, capsaicin cream, local anesthesia, opioids, steroids, and others), indication (diabetic neuropathy, trigeminal neuralgia, post-herpetic neuralgia, chemotherapy-induced peripheral neuropathy and others), distribution channel (retail pharmacies, hospital pharmacies, and online pharmacies) across prominent regions (North America, Latin America, Europe, Asia Pacific and MEA).

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Consumers Opting For To Help The Neuropathic Pain Market Cross US$ 10414.0 Mn Between 2024 - The Think Curiouser

A new research study from JCMR with title Global Diabetic Peripheral Neuropathy Treatment Market Research Report 2029 provides an in-depth assessment of the Diabetic Peripheral Neuropathy Treatment including key market trends, upcoming technologies, industry drivers, challenges, regulatory policies & strategies. The research study provides forecasts for Diabetic Peripheral Neuropathy Treatment investments till 2029.

The report does include most recent post-pandemic market survey on Diabetic Peripheral Neuropathy Treatment Market.

Competition Analysis : Achelios Therapeutics Inc, Celgene Corp, Commence Bio Inc, Grunenthal GmbH, Immune Pharmaceuticals Inc, KPI Therapeutics Inc, Medifron DBT Co Ltd, Mitsubishi Tanabe Pharma Corp, Novaremed Ltd, Reata Pharmaceuticals Inc, Relief Therapeutics Holding AG, ViroMed Co Ltd

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Commonly Asked Questions:

At what rate is the market projected to growThe year-over-year growth for 2020 is estimated at XX% and the incremental growth of the market is anticipated to be $xxx million.

Get Up to 40 % Discount on Enterprise Copy & Customization Available for Following Regions & Country: North America, South & Central America, Middle East & Africa, Europe, Asia-Pacific

Who are the top players in the market?Achelios Therapeutics Inc, Celgene Corp, Commence Bio Inc, Grunenthal GmbH, Immune Pharmaceuticals Inc, KPI Therapeutics Inc, Medifron DBT Co Ltd, Mitsubishi Tanabe Pharma Corp, Novaremed Ltd, Reata Pharmaceuticals Inc, Relief Therapeutics Holding AG, ViroMed Co Ltd

What are the key market drivers and challenges?The demand for strengthening ASW capabilities is one of the major factors driving the market.

How big is the North America market?The North America region will contribute XX% of the market share

Enquiry for segment [emailprotected] jcmarketresearch.com/report-details/1142321/enquiry

This customized report will also help clients keep up with new product launches in direct & indirect COVID-19 related markets, upcoming vaccines and pipeline analysis, and significant developments in vendor operations and government regulations

Geographical Analysis:

North America: United States, Canada, and Mexico.

South & Central America: Argentina, Chile, and Brazil.

Middle East & Africa: Saudi Arabia, UAE, Turkey, Egypt and South Africa.

Europe: UK, France, Italy, Germany, Spain, and Russia.

Asia-Pacific: India, China, Japan, South Korea, Indonesia, Singapore, and Australia.

Market Analysis by Types: Antimunocel, ASP-8477, BNV-222, Capsaicin, CBX-129801, Others

Market Analysis by Applications: Hospital, Clinic, Others

Some of the Points cover in Global Diabetic Peripheral Neuropathy Treatment Market Research Report is:

Chapter 1: Overview of Global Diabetic Peripheral Neuropathy Treatment Market (2013-2025) Definition Specifications Classification Applications Regions

Chapter 2: Market Competition by Players/Suppliers 2013 and 2018 Manufacturing Cost Structure Raw Material and Suppliers Manufacturing Process Industry Chain Structure

Chapter 3: Sales (Volume) and Revenue (Value) by Region (2013-2018) Sales Revenue and market share

Chapter 4, 5 and 6: Global Diabetic Peripheral Neuropathy Treatment Market by Type, Application & Players/Suppliers Profiles (2013-2018) Market Share by Type & Application Growth Rate by Type & Application Drivers and Opportunities Company Basic Information

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Diabetic Peripheral Neuropathy Treatment Market to Witness Huge Growth by 2028 | Achelios Therapeutics Inc, Celgene Corp, Commence Bio Inc - Eurowire

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Neuropathy Pain Treatment Market 2020 SWOT Analysis By Major Eminent Vendors: Pfizer, Depomed, Eli Lilly - The Think Curiouser

Q3 2020 NeuroMetrix Inc Earnings Call WALTHAM Oct 22, 2020 (Thomson StreetEvents) -- Edited Transcript of NeuroMetrix Inc earnings conference call or presentation Thursday, October 22, 2020 at 12:00:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Shai N. Gozani NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary * Thomas T. Higgins NeuroMetrix, Inc. - Senior VP, CFO & Treasurer ================================================================================ Conference Call Participants ================================================================================ * Jarrod M. Cohen JM Cohen & Company - MD * William Church ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good morning, and welcome to the NeuroMetrix Third Quarter 2020 Earnings Call. My name is Shannon, and I will be your moderator on the call. On this call, the company may make statements which are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are predictive in nature that depend upon or refer to future events or conditions are forward-looking statements. Any forward-looking statements reflect current views of NeuroMetrix about future results of operations and other forward-looking information. You should not rely on forward-looking statements because actual results may differ materially as a result of a number of important factors, including those set forth in the earnings release issued earlier today. Please refer to the risks and uncertainties, including the factors described under the heading Risk Factors in the company's periodic filings with the SEC available on the company's Investor Relations website at neurometrix.com and on the SEC's website at sec.gov. NeuroMetrix does not intend and undertakes no duty to update the information disclosed on this conference call. I'd now like to introduce the NeuroMetrix Senior Vice President and Chief Financial Officer, Mr. Thomas Higgins. Mr. Higgins? -------------------------------------------------------------------------------- Thomas T. Higgins, NeuroMetrix, Inc. - Senior VP, CFO & Treasurer [2] -------------------------------------------------------------------------------- Thank you, Shannon. I'm joined on the call by Dr. Shai Gozani, our President and Chief Executive Officer. NeuroMetrix develops and commercializes neurostimulation-based medical devices for the diagnosis and treatment of chronic health conditions. Our commercial products are DPNCheck, ADVANCE and Quell. DPNCheck is a point-of-care test for the detection of peripheral neuropathies. ADVANCE is a point-of-care device that provides neuro conduction studies as an aid in diagnosing and evaluating patients suspected of having focal or systemic neuropathies. And Quell is a wearable mobile app-enabled neurostimulation device indicated for symptomatic relief and management of chronic pain. It is available over the counter. Q3 was a good quarter for the company, particularly considering the larger economic environment and the operating constraints imposed by managing the business with employee safety as the top priority. We experienced a rebound in customer orders from the second quarter of 2020. Production was busy throughout Q3 and facility utilization was necessarily high to address customer needs. Our operating activities, that is R&D, sales and marketing and G&A, were all tightly managed. The forward outlook remains unclear. We appreciate the customer demand levels, raw material supply and staffing issues all have a high degree of uncertainty. However, the business performance in Q3 leaves us with a sense of optimism as we enter the last quarter of the year. Turning to our operating results in Q3, which we reported earlier today. Total revenue was about $2 million. DPNCheck orders were strong in the quarter for both devices and biosensors. Demand in the Medicare Advantage sector from new accounts as well as long-standing customers led the way. Our Japanese business with Fukuda Denshi also contributed meaningfully to the quarter results. The ADVANCE diagnostic business rebounded from the depressed levels of Q2, and Quell contributed revenue and product line profitability. Our gross profit on revenue was $1.5 million. This was a gross margin rate of 73.6%. The strong margin level was an encouraging outcome from our efforts at targeting a sustainable margin of 70% plus going forward. Lower indirect production costs and higher throughput contributed to the margin. OpEx spending totaled just under $1.8 million. This level of spending has been consistent over the past 2 quarters, and it's about 1/3 below Q3 of 2019. The current spending level is sustainable going forward. R&D spending of $652,000 was about flat with the prior quarter and 37% higher than Q3 2019. It reflected R&D activity with a primary focus on the next-generation DPNCheck technology for release next year 2021. Sales and marketing spending of $340,000 was down 47% from Q3 of last year. And G&A spending of $762,000 was down 48% from Q3 of last year and reflects reduced professional services. Our net loss for the year was -- for the quarter was $257,000. This was an improvement of $1.1 million or 82% improvement versus Q3 2019 net loss of $1.4 million. On a per share basis, the Q3 2020 loss was $0.07 per share versus a loss of $1.44 per share in Q3 last year. Cash at the end of Q3 was $4.9 million, an amount sufficient to fund the company's operations into and likely through Q4 of 2021. Our capital structure is debt-free. There are about 3.8 million common shares outstanding. With that, let me turn this over to Dr. Gozani, who will now address our overall strategy. -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [3] -------------------------------------------------------------------------------- Thank you. As Tom outlined, we are pleased with the company's performance in the third quarter. So I'll take this opportunity to review our business strategy, which is built around 3 principles. The first is that we have prioritized attainment of profitability. This past quarter was encouraging in this respect as we reported an operating loss of about $250,000. We have established an efficient cost structure throughout the business. This covers headcount, manufacturing, marketing and distribution, which has led to lower operating expenses and improving gross margins. I should point out that our ability to realize these efficiencies is a testament to the commitment and talent of our employees. Because of the overall economic uncertainty and the need to get more experience with our business initiatives, we are not currently positioned to state a specific crossover quarter into profitability at this time. The second principle in our strategy is innovation. Our corporate mission is to bring innovative health care products to our customers that improve their health and quality of life. Our products are unquestionably the most advanced in their categories, whether that is neuropathy diagnostics or TENS devices. We have and will continue to maintain our historical focus and investment in R&D. The recent example is our launch of the Quell Watch app, the first smartwatch app to control a wearable pain relief device. Also, as we have previously announced, we are updating all elements of the DPNCheck system, which includes the device itself, the consumable biosensor and the associated reporting software. We recently launched the updated biosensor and expect to release the new software, which includes enterprise and data security features that our large Medicare Advantage customers are requesting. We expect to launch that before the end of the year. And the last principle in our strategy is maintaining a dynamic market strategy. We believe that achieving profitability and leveraging our industry-leading innovation requires a flexible strategy. By that, I mean that we need to be nimble in finding the best opportunities for our products. This is most clearly manifested in Quell, where we have defined 4 core clinical indications. The current application for Quell is lower extremity chronic pain, primarily knee pain, which affects up to 25% of adults in the U.S. Quell is particularly well suited to this application because of its typical placement near the knee and its novel wearable design that enables user activity. We have identified 3 additional indications that we plan to develop: fibromyalgia, chemotherapy-induced peripheral neuropathy or CIPN and restless leg syndrome or RLS. In combination, these conditions represent a market of 10 million to 20 million individuals in the U.S. We have pilot or randomized controlled trial data on all 3 with our fibromyalgia program the furthest along. We hope to announce program updates in the second half of next year. In summary, NeuroMetrix has novel products that are targeting large markets. We are committed and operationally efficient organization that is structured to support growth and move towards profitability. That completes our prepared comments, and we'd be happy to take any questions at this point. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) Our first question comes from Jarrod Cohen with JM Cohen & Company. -------------------------------------------------------------------------------- Jarrod M. Cohen, JM Cohen & Company - MD [2] -------------------------------------------------------------------------------- Yes. Just a quick question. It's been, I guess, what, 5 years since you've launched the Quell. And I'm just curious what your opinion is in terms of why haven't you seen more reoccurring revenue from the gel packs. Since I think you have, what, a little over 200,000 -- you sold a little bit over 200,000 Quell devices in the 5 years since then. -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [3] -------------------------------------------------------------------------------- Yes. That's correct, Jarrod. We have -- we've shipped around 200,000 devices over -- it's about 5.5 years now. Yes, I think there's -- we do have a recurring revenue stream from our Quell customers. And as you might expect in a consumer-oriented product, you are going to have churn and trail off of customers over time. Many customers use our product for a period of time. It helps them. They move -- they potentially don't need it anymore or they come back and forth or they go on to alternative therapy. So it's a fairly dynamic situation. I would say, overall, I would agree with you that we're not -- we're a little bit disappointed overall in the consistency of the recurring revenue stream from the consumables and are -- in fact, I think our moving-forward strategy is somewhat reflective of that, where we're focused on more specific indications that I think we can build better connections to the consumers and better serve their needs to get a stronger recurring revenue and more consistent recurring revenue stream. But I think, overall, the answer to your question is there are many reasons, some of which are expected and some of which I think we're somewhat disappointed. But we do have a consistent revenue stream from those customers and continue to see that, but we need to improve on it. -------------------------------------------------------------------------------- Jarrod M. Cohen, JM Cohen & Company - MD [4] -------------------------------------------------------------------------------- Okay. Because you don't give an exact -- but do you see from the existing installed base, about 25% of them coming back to you or even less than that? You don't give an exact number, I know that, but I'm just curious at this point in the life cycle. -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [5] -------------------------------------------------------------------------------- Yes. I don't have a good number to give you in that respect, and I think it's kind of a complicated situation. So I don't want to quote a number. Also for competitive reasons, we tend to be fairly subdued on what we describe. But it really depends. I mean, there's a wide variation among customers. I think it needs to be improved, clearly. And again, by being more focused on specific indications that allow us to build more specific services and support setting to the app and to our customer service for those applications, I think we'll strengthen that going forward. -------------------------------------------------------------------------------- Operator [6] -------------------------------------------------------------------------------- (Operator Instructions) Our next question comes from Bill Church with Tgra. -------------------------------------------------------------------------------- William Church, [7] -------------------------------------------------------------------------------- DPNCheck, how much market share growth is in front of us that we see going forward? -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [8] -------------------------------------------------------------------------------- Well, we have no -- so that's a good question. I mean the -- there is no competition, so we're the only player in peripheral neuropathy diagnostics at the point of care. So I think there's tremendous opportunity in terms of what the overall market. I mean we're at a fairly early stage, even in terms of our core effort in Medicare Advantage. So I would say that there is significant growth opportunities. We're probably at less than, I would say, what, 5% to 10% of the -- even Medicare Advantage opportunity, which is our core focus in the U.S. and even at lower percentages in international markets, so tremendous growth. Now I want to point out, I mean, this is an emerging concept for many plans and insurers to screen for peripheral neuropathy. So while the opportunity is quite large, there's a lot of education that has to go along with that, but the opportunity is quite impressive. -------------------------------------------------------------------------------- William Church, [9] -------------------------------------------------------------------------------- So how do we realize that? Or I know you've got the new software update coming and that sort of thing. But it's just getting the word out, I guess, or be improved for insurance plans and so forth? -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [10] -------------------------------------------------------------------------------- Well, in the U.S., our core focus is on Medicare Advantage accounts. We are in the 2 largest Medicare Advantage insurers in the country. So we've -- over the last 4, 5 years have become sort of standard of care within those insurers. And as they are expanding their footprint, as they are implementing programs, we tend to go along with that. It's not -- it's difficult to push the growth at the rate we'd like to see, because we're dealing with very large organizations, and they tend to develop relatively slowly. So it is getting the word out. It's providing the right kind of software to integrate into their enterprise solutions, and it's growing along with them and growing along with the Medicare Advantage business overall. So to your point, I mean, yes, we try to get the word out. We try to provide the right support. We'd obviously like to see it grow faster, but there is a pace to it that we have to appreciate. -------------------------------------------------------------------------------- Operator [11] -------------------------------------------------------------------------------- (Operator Instructions) I'm currently showing no further questions at this time. I'd like to turn the call back over to Dr. Gozani for closing remarks. -------------------------------------------------------------------------------- Shai N. Gozani, NeuroMetrix, Inc. - Founder, Chairman, CEO, President & Secretary [12] -------------------------------------------------------------------------------- Thank you, and we appreciate you joining us on this call today and look forward to updating you early next year. -------------------------------------------------------------------------------- Operator [13] -------------------------------------------------------------------------------- Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

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Edited Transcript of NURO.OQ earnings conference call or presentation 22-Oct-20 12:00pm GMT - Yahoo Finance

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Fact.MR Report: What is the impact of Coronavirus on Diabetic Neuropathy Market Growth - The Cloud Tribune

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The Cardiac Autonomic Neuropathy Treatment market study is a well-researched report encompassing a detailed analysis of this industry with respect to certain parameters such as the product capacity as well as the overall market remuneration. The report enumerates details about production and consumption patterns in the business as well, in addition to the current scenario of the Cardiac Autonomic Neuropathy Treatment market and the trends that will prevail in this industry.

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key players in Cardiac autonomic neuropathy treatment market are Pfizer Inc., Roche Holding AG, Novartis, Amgen Inc., Privi Pharma Limited, Silverline Chemicals Limited, Anthem Biopharma, Praxis Pharmaceutical.

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Cardiac Autonomic Neuropathy Treatment Market Is Expected To Experience An Impressive CAGR Growth Of XX% Through 2017 2025 - TechnoWeekly

INDIANAPOLIS and CAMBRIDGE, Mass., Oct. 15, 2020 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY) today announced a definitive agreement to acquire Disarm Therapeutics, a privately-held biotechnology company creating a new class of disease-modifying therapeutics for patients with axonal degeneration. Disarm has discovered novel, potent SARM1 inhibitors and is advancing them in preclinical development, with the goal of delivering breakthrough treatments to patients with peripheral neuropathy and other neurological diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis.

Axonal degeneration is a common, yet unaddressed, pathology in a broad range of neurological diseases and is known to cause severe sensory, motor, and cognitive symptoms. Disarm's scientific founders, Dr. Jeffrey Milbrandt and Dr. Aaron DiAntonio of Washington University School of Medicine in St Louis, discovered that the SARM1 protein is a central driver of axonal degeneration. Disarm's SARM1 inhibitors are designed to directly prevent the loss of axons.

Under the terms of the agreement, Lilly will acquire Disarm for an upfront payment of $135.0 million. Disarm equityholders may be eligible for up to $1.225 billion in additional future payments for potential development, regulatory and commercial milestones should Lilly successfully develop and commercialize new medicines resulting from the acquisition.

"Lilly continues to seek medicines to treat the debilitating pain and loss of function associated with nerve damage," said Mark Mintun, M.D., vice president of pain and neurodegeneration research at Lilly. "The scientific team at Disarm discovered an important and highly promising approach to combat axonal degeneration. We will move quickly to develop their SARM1 inhibitors into potential medicines for peripheral neuropathy and neurological diseases, such as ALS and multiple sclerosis."

"Disarm's innovative approach to treating axonal degeneration holds tremendous promise for addressing a wide spectrum of neurological diseases, and we have made significant strides toward enabling potentially transformative therapies," said Alvin Shih, M.D., Chief Executive Officer of Disarm. "Lilly is ideally suited to advance this exciting new approach to treating axonal degeneration, and we look forward to seeing patients benefit from the work that Disarm initiated." Disarm was founded by Atlas Venture, Drs. Milbrandt and DiAntonio of Washington University School of Medicine in St. Louis, and Atlas Entrepreneurs-in-Residence Dr. Rajesh Devraj and Dr. Raul Krauss. Lightstone Ventures and AbbVie Ventures co-invested with Atlas to support the foundational work at Disarm.

This transaction will be reflected in Lilly's reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly's 2020 non-GAAP earnings per share guidance as a result of this transaction.

Aquilo Partners, L.P. acted as financial advisor and WilmerHale LLP as legal advisor to Disarm on this transaction.

About Disarm TherapeuticsDisarm Therapeutics is a biotechnology company that is creating a new class of disease-modifying therapeutics for patients with axonal degeneration, a central driver of neurological disability and disease progression. By inhibiting the SARM1 protein, identified by the company's scientific founders as the central driver of axonal degeneration, these therapeutics may prevent the loss of axons in chronic and acute diseases of the central, ocular, and peripheral nervous systems. For a broad range of diseases including multiple sclerosis, amyotrophic lateral sclerosis, glaucoma, and peripheral neuropathies, the therapeutic goal is to prevent further degeneration, stabilize disease, and allow for functional recovery.

AboutEli Lilly and CompanyLilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at http://www.lilly.com. C-LLY

Lilly Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the benefits of Lilly's acquisition of Disarm Therapeutics ("Disarm"), and reflects Lilly's current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in implementing the transactionand in the process of drug development and commercialization. Among other things, there can be no guarantee that the transaction will be completed in the anticipated timeframe, or at all, or that the conditions required to complete the transaction will be met, that Lilly will realize the expected benefits of the acquisition, or that the acquisition will yield commercially successful products. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Refer to:Mark Taylor; [emailprotected]; (317) 276-5795 (Lilly Media)Kevin Hern; [emailprotected];(317) 277-1838 (Lilly Investors)Stephanie Simon; [emailprotected]; (617) 581-9333 (Disarm Media)

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Lilly Announces Agreement to Acquire Disarm Therapeutics - PRNewswire

Several late-phase results were shared during the European Society of Medical Oncology (ESMO) Virtual Congress in gynecologic malignancies, but the data presented generated excitement about the number of novel options for patients after initial treatment.

Updated findings in ovarian cancer demonstrated continued benefit for PARP inhibition as maintenance therapies following frontline treatment in advanced ovarian cancer in the phase 3 SOLO-1 trial (NCT01844986) using the PARP inhibitor olaparib (Lynparza) and in the phase 2 PRIMA/ENGOT-OV26/GOG-3012 ([PRIMA], NCT02655016), which utilized the PARP inhibitor niraparib (Zejula).

Enthusiasm also surrounded a potential new approach in cervical cancer from the phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 study ([innovaTV], NCT03438396), which explored treatment with the investigational antibody-drug conjugate tisotumab vedotin.

The longest duration of follow-up for any PARP inhibitor in the previously untreated advanced ovarian cancer setting was performed in the phase 3, randomized, double-blind, placebo-controlled, multicenter SOLO-1 trial, in which olaparib maintenance was given to patients with BRCA mutations. The 5-year follow-up results were presented at ESMO by Susan Banerjee, MD, PhD, FRCP, consultant medical oncologist and research lead for the Gynecology Unit at The Royal Marsden.1

The updated analysis after 5 years of follow-up shows that the benefit of olaparib continues substantially beyond the end of treatment, Banerjee told Targeted Oncology in an interview.

Out of the 391 patients assessed, 260 received olaparib maintenance and 131 received placebo for up to 2 years or until progressive disease (PD). Olaparib maintenance first demonstrated an improvement in progression-free survival (PFS) in the primary analysis with the median PFS not yet reached in the olaparib arm at this timepoint compared with 13.8 months in the placebo arm (HR, 0.30; 95% CI, 0.23-0.41).

The median follow-up for the updated analysis was 4.8 years in the olaparib arm compared with 5.0 years in the placebo arm. The results showed PFS events in 45% of the olaparib-treated population versus 76% of the placebo population. The median PFS observed with olaparib maintenance was 56.0 months compared with 13.8 months in the placebo arm (HR, 0.33; 95% CI, 0.25-0.43).

These are very encouraging results that will help us explain the potential benefits of maintenance olaparib in patients with BRCA mutations, said Banerjee.

A new analysis of the phase 3 randomized, double-blind, placebo-controlled, multicenter PRIMA trial presented during ESMO by GiorgioValabrega, MD, investigated the potential difference in efficacy and safety by age of niraparib maintenance after chemotherapy in patients with advanced ovarian cancer.

The key findings of our trial were that there is no difference in terms of safety and efficacy by adding niraparib to chemotherapy. Also, the [adverse events] that were observed in patients above 65 and 75 [years of age] in comparison to younger patients are not different, Valabrega, associate professor, University of Torino School of Medicine, told Targeted Oncology in an interview.

The subanalysis included 444 patients from the original PRIMA study who were 65 years of age or younger. Of the patients included in this analysis, 297 received niraparib and 147 received placebo.2

A second cohort from the analysis included 289 patients aged 65 or older. Among this group, 76 patients were 75 years or older. One hundred ninety of the patients received niraparib maintenance while 99 received placebo in the younger cohort and of those 75 years or older, 54 patients received niraparib and 22 received placebo.

Demonstrating consistency with the primary analysis which showed a median PFS on 13.8 months with niraparib compared with 8.2 months in the placebo arm, niraparib maintenance prolonged PFS compared with placebo in this subanalysis. In the patients under the age of 65, the median PFS was 13.9 months with niraparib versus 8.2 months with placebo (HR, 0.61; 95% CI, 0.47-0.81). Patients aged 65 or older had a median PFS of 13.7 months with niraparib versus 8.1 months with placebo (HR, 0.53; 95% CI, 0.39-0.74). In the 75 years of age or below group, niraparib led to a median PFS of 13.8 months compared with placebo, which had a median PFS of 8.2 months (HR, 0.62; 95% CI, 0.50-0.77). Finally, in patients aged 75 of older, the median PFS was 13.8 months with niraparib versus 5.6 months with placebo (HR, 0.37; 95% CI, 0.17-0.81).

Both ages groups were similar in terms of the number percentage of treatment-emergent adverse events (TEAEs) observed. The most common treatment-emergent TEAEs were anemia, leukopenia and hypertension. Notably, patients aged 65 years or older experienced a small increase in thrombocytopenia during treatment as did those aged 75 years of age or older. The rates of 3 TEAEs were also similar between the age groups.

Results from the single-arm, multicenter, international phase 2 study innovaTV were presented during ESMO by Robert Coleman, MD, FACOG, FACS, chief scientific officer of The US Oncology Network. The result of the study was that treatment with tisotumab vedotin led to antitumor activity in patients with previously treated recurrent or metastatic cervical cancer.3

We basically confirmed the responses that we saw in the first-in-human phase 1 and 2 study with a 24% response rate, Coleman told Targeted Oncology.

Importantly, 7% of those patients had complete response, which, for those of who have treated this disease, these are not common findings, he added.

As Coleman shared, the objective response rate observed in the trial was 24% (95% CI, 15.9%-33.3%), with complete responses in 7% of the population, partial respondes in 17%, and stable disease in 49%. In terms of PD, 24% of patients progressed on treatment. The median duration of response observed with tisotumab vedotin was 8.3 months (95% CI, 4.2 to not reached). Notably, the treatment also led to a decrease in target lesion size in 79% of the patients who received tisotumab vedotin when compared with their baseline measurements.

Among the confirmed responders, the median time to response was 1.4 months (range, 1.1-5.1). It was also noted during Colemans ESMO presentation that responses were seen across the subgroup populations explored, regardless of tumor histology, lines of prior therapy, or responses to prior treatment.

The median PFS achieved with tisotumab vedotin was 4.2 months (95% CI, 3.0-4.4). At 6 months, the PFS rate was 30% (95% CI, 20.8%-40.1%). The median overall survival with the agent was 12.1 months (95% CI, 9.6-13.9) and the 6-month OS rate was 79% (95% CI, 69.3%-85.6%).

Treatment-related AEs (TRAEs) occurred in greater than 10% of the study population. The majority of the (TRAEs) observed in this study were grade 1 and 2 in severity. The most TRAEs of any grade were alopecia (38%), epistaxis (30%), nausea (27%), conjunctivitis (26%), and fatigue (24%). One patient in the died as a results of treatment-related septic shock.

Ocular, bleeding, and neuropathy TRAEs were also assessed in the study and bleeding TRAES were most prevalent, with grade 1 events having observed in 34% of patients. Ocular TRAEs were the second most prevalent with grade 1 events having occurred in 25% of patients. Finally, grade 1 peripheral neuropathy occurred in 17% of patients.

Data from this study led to the conclusion that tisotumab vedotin is a potential new treatment option for patients with previously treated recurrent of metastatic cervical cancer.

References:

1. Banerjee S, Moore KN, Colombo N, et al. Maintenance olaparib for patients (pts) with newly diagnosed, advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): 5-year (y) follow-up (f/u) from SOLO1. Presented at: 2020 ESMO Virtual Congress; September 19-21, 2020. Virtual. Abstract 811M0.

2. Valabrega G, Pothuri B, Oaknin A, et al. Efficacy and safety of niraparib in older patients (pts) with advanced ovarian cancer (OC): Results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Presented at: 2020 ESMO Virtual Congress; September 19-21, 2020; Virtual. Abstract 819P.

3. Coleman RL, Larusso D, Gennigens C, et al. Tisotumab vedotin in previously treated recurrent or metastatic cervical cancer: results from the phase 2 innovaTV 204/GOG-3023/ENGOT-cx6 study. Presented at: 2020 ESMO Virtual Congress; September 19-21, 2020; Virtual. Abstract LBA32.

Original post:
Updated Findings Show Continued Benefit of PARP in Ovarian Cancer, New Agent on the Scene in Cervical Cancer - Targeted Oncology

When it comes to exercise for arthritis, even simple moves like stretching can help ease joint pain and stiffness.

Image Credit: kali9/E+/GettyImages

If you have arthritis, going for a jog may seem like it would do your joints more harm than good. But as counterintuitive as it seems, physical activity may be just what the doctor ordered.

About 54 million people in the U.S. have been diagnosed with arthritis, an inflammatory condition that causes joint pain and swelling.

These symptoms can also prevent people from exercising: Almost 24 percent of people with arthritis don't do any physical activity (compared to about 18 percent of those without the condition), according to the Centers for Disease Control and Prevention (CDC).

"In general, people with arthritis tend to want to take it easy or not exercise as much," Brian Andonian, MD, a rheumatologist and assistant professor of medicine at Duke University School of Medicine, tells LIVESTRONG.com. "But exercise, done right, is probably one of the most beneficial things they can do to help their joints."

Osteoarthritis, the most common type of arthritis in the U.S., occurs when the cartilage surrounding the ends of bones (such as those of the knees and hands) break down which is partly why it's known as "wear and tear" arthritis. But in some ways, that definition can be misleading.

"The 'wear and tear' component is really much more specific," says Joseph Garry, MD, a visiting professor of clinical family medicine at the University of Illinois College of Medicine Rockford. "It's not so much moving or exercising."

Rather, he explains, osteoarthritis can be caused by overloading the joint, by being overweight, maybe, or by carrying lots of heavy objects at work. Joint injuries, such as those sustained by playing a sport, may also increase the risk for osteoarthritis, he says.

Exercise, however, can help ease pain from osteoarthritis as well as from other inflammatory types of arthritis, including rheumatoid and psoriatic arthritis, says Dr. Andonian.

Ready to get started? Here's a closer look at why exercise is so beneficial for people with arthritis, and how to start working out safely.

Why Exercise Is Good for Arthritis

Exercise can reduce pain, improve joint function and boost the quality of life of people with arthritis, according to the CDC.

One early investigation into exercise and arthritis, published January 2008 in the journal Arthritis & Rheumatism, found that people with arthritis who participated in an exercise program felt less pain and fatigue at the end of eight weeks than those who didn't work out. Plus, they continued to feel less pain and fatigue six months later.

Newer research has confirmed those findings, concluding that even short periods of activity can help prevent joint pain from worsening. In a study published May 2019 in the American Journal of Preventive Medicine, people with joint pain who performed one hour of moderate-to-vigorous activity a week were less likely to develop a disability after four years as those who weren't as active.

"Any exercise for somebody with arthritis who's sedentary is going to be helpful. Every little bit adds up, even a few minutes here and there."

Exercise can help ease joint pain in a few ways, says Dr. Andonian. For starters, he says, physical activity can strengthen the muscles that surround the joint, which helps take some of the pressure off the joint itself. It also helps you sleep better, which can also help ease pain.

Another way exercise can help ease arthritis symptoms is by lowering the levels of inflammation in the body, which is a characteristic of arthritis, he says.

"I think of exercise as being an anti-inflammatory treatment," says Dr. Andonian. "We know that exercise has pretty powerful ways of [regulating] the way the immune system works."

Specifically, he explains, fat is more pro-inflammatory than lean muscle mass, which tends to be more anti-inflammatory and beneficial for arthritis.

The Best Types of Exercise for Arthritis

Yoga is a great way to improve your balance and range of motion when you have arthritis.

Image Credit: Ridofranz/iStock/GettyImages

Because both aerobic exercise and strength training improve body composition, doing either one and ideally both can help improve arthritis symptoms, Dr. Andonian says.

Other types of activity that you may want to try include range-of-motion and body awareness exercises, according to the American College of Rheumatology.

Here are some examples of these four main types of exercise, plus good options for people with arthritis:

3. Range-of-Motion Exercises

4. Body Awareness Workouts

If you're just starting an exercise program, one of the best things you can do is commit to an activity that you like to do, and one that's also compatible with your schedule and lifestyle.

"Keeping up a program in the long-term has got to be enjoyable," Dr. Andonian says.

The CDC recommends adults get at least 150 minutes of moderate-intensity aerobic exercise or 75 minutes of vigorous exercise each week, but if you haven't been exercising very much (if at all), try working up to that goal slowly, over time, says Dr. Andonian.

"Any exercise for somebody with arthritis who's sedentary is going to be helpful," he says. "Every little bit adds up, even a few minutes here and there."

Are There Any Risks to Exercising With Arthritis?

Before you start a new exercise program, it's a good idea to let your doctor know what you're doing, says Dr. Andonian. Your provider may be able to refer you to another health care professional, like a physical therapist, who can design a workout plan for you and even help coach you through the movements.

After you start exercising, you'll probably feel some stiffness or swelling, possibly for six to eight weeks, according to the CDC. But that's OK.

"A little bit of soreness isn't necessarily a bad thing, especially if you're starting to get some gains over time," Dr. Andonian says.

That said, you may want to modify certain exercises to make them more comfortable for you, he says. For example, if you have knee osteoarthritis, you can try starting a walking program, but avoid climbing a lot of hills. Or, if you want to try cycling but have arthritis in your spine or hip, he recommends sitting on a bike in a reclined position, which can be more comfortable.

Even if you're having a flare-up of arthritis, it's still a good idea to try to do some exercise.

"A lot of people just completely stop all activities," he says. "I recommend that people try to stay active as much as they can within their comfort zone, even just doing light activities like range-of-motion type exercises."

If you happen to feel any sharp, stabbing and constant pain, pain that causes you to limp or pain in your joints that are red or feel "hot," the CDC recommends calling your doctor.

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The 4 Best Types of Exercise to Ease Arthritis Pain and Stiffness - LIVESTRONG.COM

Arthritis leads to inflammation and pain in joints. It reduces mobility and make it difficult to perform day to day activities. Here are some foods that you should avoid if suffering from arthritis.

Arthritis diet should include foods anti-inflammatory foods

Arthritis is a condition that affects the joints of an individual. It leads to pain, stiffness and inflammation in the joints. The symptoms of arthritis worsen with age. There are several types of arthritis that can affect a person. Pain, stiffness, swelling, reduced range of motion and redness near the joints are some typical symptoms of this condition. Arthritis diet includes foods that can help ease inflammation and joint pain. It is usually suggested to add anti-inflammatory foods to an arthritis diet. Therefore, people with arthritis are often advised to avoid foods that can trigger inflammation. Here's a list of foods that people with arthritis should be avoiding.

Consumption of sugar in excess can result in inflammation as per studies. It can also lead to weight gain which can make it hard to manage this condition. Sugar is usually hidden in several foods and drinks. You should also avoid foods with added sugar.

Consuming too much sugar can contribute to weight gainPhoto Credit: iStock

Ultra-processed foods may also contain inflammatory ingredients that can worsen the symptoms of arthritis. Highly processed foods are generally high in salt and sugar which are harmful to your health when consumed in excess.

Also read:Arthritis Diet: 5 Anti-Inflammatory Foods That Should Be A Part Of Your Diet

Studies have shown that drinking too much alcohol can increase the severity of gout which is a type of arthritis. It can also increase inflammation. Too much alcohol consumption is also linked with several health conditions.

Also read:These Remedies Can Help Relieve Arthritis Pain Naturally

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Studies have also highlighted that consuming processed meat regularly may demonstrate high levels of inflammation.

Disclaimer: This content including advice provides generic information only. It is in no way a substitute for qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.

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Arthritis Diet: Avoid These Foods And Drinks To Fight Inflammation Effectively - Doctor NDTV