Monthly Archives: June 2020

Ali Shilatifard

A pandemicespecially one caused by a mysterious or newly discovered infectious agentengenders a stark reminder that supporting fundamental research has been a prudent investment of public funds. Fundamental molecular research plays an essential role in the clinic to decipher infectious processes, develop therapeutic strategies, and guide physicians, nurses, and other hospital employees in implementing the most effective application of new knowledge. As the world begins the process of healing from the medical, social, and economic effects of coronavirus disease 2019 (COVID-19), public health is at the forefront of decision-making by lawmakers at both the federal and state levels. Daily news conferences and press releases illustrate the importance of scientists and physicians as major partners in pandemic task forces, guiding politicians in health policy decision-making. Basic molecular research plays a crucial role in helping the world overcome the current pandemic and prepare for the next one.

The first application of fundamental molecular research to COVID-19 was rapid sequencing of the SARS-CoV-2 RNA genome using a process known as next-generation sequencing (NGS). These data immediately delivered the scientific and clinical communities with insight into the singular properties of this coronavirus strain. NGS can provide billions of DNA reads in a single day, a process that was unfathomable only 15 years ago. Now an essential and nearly ubiquitous technology, NGS evolved through the research of biochemists, molecular biologists, and engineers who were supported by grants from publicly funded institutions such as the U.S. National Institutes of Health (NIH), National Cancer Institute (NCI), and their counterparts across the globe. The second major application of fundamental molecular research to COVID-19 was the development of an assay to identify infected individuals. The method of choice for high-sensitivity detection of the virus in people is reverse transcription followed by polymerase chain reaction (RT-PCR), which takes advantage of the viral genome sequence provided by NGS. A key component of this assay is the reverse transcriptase RNA-dependent DNA polymerase, which converts the viral RNA genome into a DNA molecule that can be amplified and detected. This enzyme was a Nobel prize winning discovery by NIH/NCI-supported researchers Howard Temin and David Baltimore. Although the PCR amplification methods and instruments were finalized in the private sector, much of the enzymology and nucleic acid chemistry that spurred PCR development was based on publicly funded fundamental molecular research.

Developing COVID-19 therapeutics requires an in-depth understanding of molecular processes involved in the viral life cycle. Antiviral therapies are needed to treat patients with mild to moderate symptoms. Additional therapies are needed for COVID-19 patients who suffer cytokine storm, which progresses to critical stages of respiratory failure, septic shock, and multiorgan dysfunction. Given that COVID-19 is within the family of RNA viruses, researchers are well positioned to begin development of antiviral therapies, as biochemists already have generated a plethora of molecular information about the atomic structures for the main enzyme required for viral replication, the RNA-dependent RNA polymerase, an enzyme which has no known host counterpart. In this case, biochemists and transcription biologists have already identified Remdesivir, an adenosine nucleotide analog that interferes with the action of viral RNA-dependent RNA polymerase activity. Clinical trials of the drug are currently underway, and early results are encouraging. As for the treatment of cytokine storm, again, basic biochemical research in immunology has paved the way for the development of several therapies, including interleukin-6 (IL-6) inhibitors that function by blocking the IL-6 receptor and ameliorate unwanted damage to tissues and organs caused by cytokine release as the result of viral infection.

The ultimate aim for the treatment of all viral infections, including COVID-19, is the development of host and herd immunity, which can be accomplished either through host infection or vaccination. To manage potential pandemics with the least number of casualties, researchers must develop vaccines that can be mass produced on a scale of hundreds of millions of doses within in a few months after a virus appears and that can be rapidly distributed across the globe. Traditional vaccines use either active or weakened virus or destroyed forms of viral particles as the immune responsegenerating agent. The use of attenuated and destroyed viral particles as vaccines is highly effective, but the manufacturing process is arduous and time-consuming. Recombinant RNA and DNA vaccines circumvent these shortcomings of traditional vaccine generation and are in clinical trial for COVID-19. In this case, humankind owes biochemists Paul Berg, Walter Gilbert, Frederick Sanger, and their colleagues a debt of gratitude for their Nobel prize winning fundamental research in developing recombinant DNA technologies. This work resulted from decades-long funding by U.S. and U.K. governmental agencies and, today, allows the design of recombinant RNA and DNA vaccines and many other life-saving medicines that take advantage of this revolutionary technology.

Once the dust from the COVID-19 pandemic settles and the U.S. Congress is back in session, I hope that lawmakers will recognize our societys dependence on thorough, methodical, mechanistic science and the medicines it provides and ask themselves how many more people might have perished from COVID-19 without the modern methods that arose from the basic molecular research described above. This catastrophe should be a reminder that a healthy investment in all institutes of the NIH and NCI and other federal science agencies will be life-saving when future pandemics arise.

This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial license, which permits use, distribution, and reproduction in any medium, so long as the resultant use is not for commercial advantage and provided the original work is properly cited.

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Medicine in the time of corona: Fundamental molecular research is essential - Science Advances

Alterations that cause skipping of exon 14 on the MET gene (METex14) are drivers of a type of lung cancer with a poor prognosis, but that is treatable with a recently approved MET inhibitor

Foundation Medicine, Inc. and Dana-Farber Cancer Institute presented new data highlighting the utility of comprehensive genomic profiling (CGP) to guide treatment decisions in patients with advanced non-small cell lung cancer (NSCLC) whose tumors also have an alteration that leads to MET exon 14 skipping (METex14). The results underscore the feasibility of tissue and liquid biopsy CGP to characterize common alterations that may be critical for predicting responses to MET inhibitors in patients with NSCLC. These data were presented in a clinical science symposium at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program.

NSCLC accounts for approximately 85% of lung cancer diagnoses, approximately 3% of which have MET exon 14 skipping.1,2 While METex14-altered NSCLC is sensitive to MET inhibition, alterations that co-occur with METex14 may cause treatment resistance to MET inhibitors.

In this analysis of more than 60,000 cases of advanced NSCLC, researchers characterized a subset of 1,387 of patients (2.3%) with METex14-altered NSCLC a prevalence consistent with previous research and identified multiple co-occurring alterations that may cause resistance to MET inhibitors.3,4,5,6 The study also identified six different subclasses of METex14 skipping alterations based on their location, illustrating the complexity of this cancer, which has a poor prognosis.7

"Diverse, co-occurring alterations in METex14 non-small cell lung cancer may correlate with primary or acquired resistance to treatment, so detecting these various alterations using comprehensive genomic profiling may be critical to predicting response to MET inhibitors," said lead study author Mark Awad, M.D., assistant professor of medicine at Harvard Medical School and clinical director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute. "These data underscore the urgent need to identify effective strategies to delay or overcome resistance to targeted therapies in METex14 mutant NSCLC."

Among 36 patients with paired tissue and liquid samples, potential resistance mechanisms to MET inhibition included 25% of patients with secondary MET alterations, 8% of patients with MET amplification and individual cases with acquired alterations in the EGFR, ERBB2, KRAS and the PI3K pathway were identified. Co-alterations and potential acquired resistance mechanisms appear largely independent of primary METex14 alteration subtype.

"This study emphasizes the importance of comprehensive genomic profiling in patients with METex14-altered NSCLC to facilitate precision medicine both earlier and throughout a patients treatment," said Brian Alexander, M.D., M.P.H, chief medical officer at Foundation Medicine and study co-author. "The study also adds more evidence that genomic testing through both tissue and liquid biopsy can be an important tool for monitoring for resistance alterations during treatment."

A full list of data being presented by Foundation Medicine and its collaborators, and more information about Foundation Medicines portfolio of CGP tests are available at http://comprehensivegenomicprofiling.com.

About METex14-altered Non-Small Cell Lung Cancer

NSCLC accounts for 80-85% of lung cancer diagnoses.1 Mutations that lead to skipping METex14, called skipping alterations, are oncogenic drivers in NSCLC. Approximately 3% of patients with NSCLC have MET exon 14 skipping.2 These tumors produce an altered form of the MET protein, which is a receptor tyrosine kinase that activates a wide range of cellular signaling pathways that can lead to cancer growth.

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

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Foundation Medicine is a registered trademark of Foundation Medicine, Inc.

Source: Foundation Medicine

1 American Cancer Society. About Lung Cancer. Available at https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed May 11, 2020.2 G.M. Frampton, S.M. Ali, M. Rosenzweig, et al.Activation of MET via diverse exon 14 splicing alterations occurs in multiple tumor types and confers clinical sensitivity to MET inhibitors. Cancer Discov, 5 (2015), pp. 850-8593 Characterization of 1,387 NSCLCs with MET exon 14 (METex14) skipping alterations (SA) and potential acquired resistance (AR) mechanisms. Abstract 9511.4 Sadiq AA, Salgia R. MET as a possible target for non-small-cell lung cancer. Journal of Clinical Oncology. 2013;31:1089-1096.5 Smyth EC, et al. Emerging molecular targets in oncology: clinical potential of MET/hepatocyte growth-factor inhibitors. Onco Targets and Therapy. 2014;7:1001-1014.6 Salgia R. MET in Lung Cancer: Biomarker Selection Based on Scientific Rationale. Molecular Cancer Therapeutics. 2017;16(4):555-565.7 Tong JH, et al. MET Amplification and Exon 14 Splice Site Mutation Define Unique Molecular Subgroups of Non-Small Cell Lung Carcinoma with Poor Prognosis. Clin Cancer Res 2016;22:3048-56.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200529005273/en/

Contacts

Lee-Ann Murphy, 617-245-3077pr@foundationmedicine.com

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Foundation Medicine and Dana-Farber Present Data at ASCO20 Showing that Comprehensive Genomic Profiling Identified Co-Occurring Alterations that May...

A recently approved first-in-class antipsychotic appears to have fewer adverse cardiometabolic effects compared with standard care with risperidone, new research suggests.

In post hoc analyses of two short-term randomized controlled trials plus an open-label long-term study, patients with schizophrenia on lumateperone (Caplyta, Intra-Cellular Therapies Inc) had reduced rates of metabolic syndrome compared with their counterparts taking placebo or the antipsychotic risperidone.

In the short-term studies, rates of metabolic syndrome were similar between groups at baseline, but by the end of 4 and 6 weeks of treatment, 25% of patients taking lumateperone no longer met criteria for metabolic syndrome. A similar finding occurred in 36% of patients in the 1-year open label study.

Dr Andrew Satlin

"One of the major advantages that we found during the drug's development was that it has a very favorable profile with regard to changes in weight, and other [parameters] associated with cardiovascular disease risk, such as elevated glucose and lipids," study investigator Andrew Satlin, MD, chief medical officer at Intra-Cellular Therapies, New York City, told Medscape Medical News.

"So we went back to our data and looked to see whether the changes that we saw had an impact on either the development or the resolution of metabolic syndrome in the patients who came into our studies," he said.

The findings were presented at the American Society of Clinical Psychopharmacology (ASCP) 2020 Virtual Conference.

As reported by Medscape Medical News, lumateperone was approved in December by the US Food and Drug Administration (FDA). The drug acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems.

The short-term studies included 511 patients randomly assigned to receive lumateperone 42 mg (n = 256 patients) or risperidone 4 mg (n = 255 patients).

At baseline, rates of metabolic syndrome were 16% in the lumateperone group and 19% in the risperidone group. At the end of treatment, metabolic syndrome was less common in the lumateperone group (13%) vs those receiving risperidone (25%).

In addition, 46% of lumateperone patients with metabolic syndrome at baseline no longer had it at the end of the study period. This compared with 25% of patients on risperidone.

More patients taking risperidone than on lumateperone developed metabolic syndrome during treatment (13% vs 5%).

The differences in metabolic syndrome conversion rates appeared to be driven by greater reductions in total cholesterol with lumateperone compared with risperidone (2.8 mg/dL with lumateperone vs 4.8 mg/dL with risperidone) and triglycerides (0.7 mg/dL with lumateperone vs 20.4 mg/dL with risperidone).

Greater increases in blood glucose were also seen with risperidone (7.7 mg/dL) than with lumateperone (0.9 mg/dL).

The long-term study included 602 patients with stable schizophrenia. All received lumateperone 42 mg, and 197 patients (33%) had metabolic syndrome at baseline.

At the end of the 1-year study, 72 of these patients (36%) no longer met criteria for metabolic syndrome.

"Lumateperone seems to be the safest antipsychotic we have seen so far," Christoph Correll, MD, professor of child and adolescent psychiatry, Charit Universitatsmedizin, Berlin, Germany, who was also involved in clinical trials of lumateperone, told Medscape Medical News.

Dr Christoph Correll

"It seems to be very safe when it comes to cardiometabolic parameters, and it shows similar reduction in symptoms as risperidone. It is certainly an agent one should consider, particularly when a patient cannot tolerate other medications or may not be in full adherence," said Correll, who has a joint appointment as professor of psychiatry and molecular medicine at the Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York.

The drug's safety and efficacy profile would make it a good candidate in patients initiating antipsychotic treatment, but reimbursement issues may be a barrier, at least for now, he added.

He said that the drug may prevent the onset of metabolic side effects and added that once payers are willing to reimburse the drug it should become the "first-line standard of care."

It is well known that atypical antipsychotics are associated with adverse and rapid metabolic changes. Correll noted that particularly early-phase and first-episode patients can be "very sensitive" to the side effects of these drugs and often experience rapid weight gain and other adverse metabolic changes. Lumateperone, he added, may help avoid some of this cardiometabolic risk.

Commenting on the findings for Medscape Medical News, Jessica M. Gannon, MD, a psychiatrist at the University of Pittsburgh in Pennsylvania, said the drug's favorable metabolic profile has previously been reported.

She also noted that there has been some interest in lumateperone due to possible "downstream effects on NMDA-type glutamate receptor activity, a larger binding ratio at D2:5HT1A receptors than other atypical antipsychotics, and presynaptic D2 partial agonism and a postsynaptic D2 antagonism."

"This latter feature may explain the reported low extrapyramidal symptom incidence in the clinical trials," she said .

"While I think future studies and clinical use can help determine how clinically efficacious this medication will be for our patients when compared to others on the market, its favorable metabolic and EPS profile do make it of interest," added Gannon, who was not involved in researching the drug.

The study was funded by Intra-Cellular Therapies. Satlin is chief medical officer of Intracellular Therapies. Correll has been a consultant or advisor to and has received honoraria from Acadia, Alkermes, Allergan, Angelini, Axsome, Gedeon Richter, Gerson Lehrman Group, Intra-Cellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, Medscape, Neurocrine, Noven, Otsuka, Pfizer, Recordati, Rovi, Sumitomo Dainippon, Sunovion, Supernus, Takeda, and Teva.

American Society of Clinical Psychopharmacology (ASCP) 2020: Abstract 3002348. Presented May 30, 2020.

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First-in-Class Antipsychotic Linked to Lower Cardiometabolic Risk - Medscape

SAINT-PREX, Switzerland & VALENCIA, Spain--(BUSINESS WIRE)--Ferring Pharmaceuticals and Igenomix today announced a two-year research collaboration aimed at the discovery of novel targets and disease mechanisms in infertility and pregnancy-related conditions, including preeclampsia, with the goal of developing innovative diagnostic and therapeutic strategies in these areas of high unmet need.

A new research hub will be created in Boston, bringing together scientists and expertise from both companies. The hub will focus on investigating molecular signatures, developing novel functional genomic systems and creating translational tools to study for embryo implantation, endometrial microbiome interaction and decidualization biology to drive innovative solutions for patients.

Today, 1 in 6 couples worldwide are affected by fertility issues, with embryo implantation being a critical step to improving success rates in assisted reproduction technologies (ART) such as IVF. Furthermore, between 3 and 5% of all pregnancies are affected by preeclampsia,1 a severe complication which increases the morbidity and mortality of both mother and baby, said Joan-Carles Arce, Senior Vice President of Reproductive Medicine and Maternal Health, Ferring. Through this collaboration, we aim to advance diagnostic testing and the discovery of candidate drug targets in these areas of high unmet need and ultimately help more people build healthy families worldwide.

This new research hub will connect Igenomixs unique diagnostic capabilities with Ferrings deep therapeutic expertise, said Professor Carlos Simn, Head of Scientific Board of Igenomix Foundation and Project Lead for the new hub. We believe this collaboration will accelerate scientific findings and improve conception rates at a time when significant progress is needed in preimplantation science to help more women and families experience healthy pregnancies.

ENDS

About Fertility Issues

The World Health Organization defines infertility as a disease of the reproductive system defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse. Today, 1 in 6 couples worldwide are affected by fertility issues. Assisted Reproductive Technologies (ART) such as In Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI) can help couples who have problems conceiving naturally.

About Preeclampsia

Preeclampsia is a common and severe complication of pregnancy characterised by high blood pressure and multiple organ failure. It affects between 3% and 5% of all pregnancies in the US.1 There is a significant unmet need for an effective treatment for preeclampsia; currently the only treatment is delivery of the baby.

Preeclampsia is responsible for approximately 20% of all preterm births2 and increases the morbidity and mortality of both mother and baby, especially in developing countries. An effective treatment would bring significant improvements in global infant and maternal health.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at http://www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

About Igenomix

Igenomix is a biotech company based in Valencia, Spain, specialized in reproductive genetics. Its expertise in fertility and its advanced research capacity situates the company as a worldwide referent in this area. Igenomix has 23 laboratories across the world and employs more than 400 professionals. Since the company launch in 2010, Igenomix has published more than 450 scientific papers and its communications have taken place during high level congresses such as ESHRE (European Society of Human Reproduction) or ASRM (American Society for Reproductive Medicine). Igenomix researchers have received numerous awards recognizing research and many of them share their knowledge and knowhow in leading US universities such as Stanford or Harvard.

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Ferring and Igenomix Collaborate to Advance Care in Reproductive Medicine and Maternal Health - Business Wire

Structural Biology and Molecular Modeling Techniques Market: Overview

The global structural biology and molecular modeling techniques market is a novel conception in the global healthcare sector and has already made key contributions in obtaining remedies to a number of diseases. The structural biology and molecular modeling field is concerned with how various molecules in biological compounds are arranged and how the peculiarity of the arrangement affects the nature of the compound. The field also studies how alterations in the structure of the compounds affect their nature and how the position of each part of the structure is linked to the overall nature of the compound.

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The structural biology and molecular modeling techniques market has significant potential due to the rising prevalence of chronic diseases. Improving the quality of medicine and healthcare in general has been a key focus of governments across the world in recent years due to the rising volume of patient demographics and the growing geriatric population. This has driven consistent investment in the medical research in recent years, making steady development of the structural biology and molecular modeling techniques market likely in the near future.

North America is likely to remain the leading regional market for structural biology and molecular modeling techniques in the coming years due to the strong emphasis on the widespread incorporation of healthcare IT and the presence of strong investment channels for the medical research field as well as several key healthcare industry players. The presence of advanced technological framework supporting research in complementary areas of the structural biology and molecular modeling techniques market, such as genomics, is also likely to be a key driver for the North America structural biology and molecular modeling techniques market in the coming years.

Global Structural Biology and Molecular Modeling Techniques Market: Snapshot

The global structural biology and molecular modeling techniques market has been thriving due to the high prevalence of chronic diseases. The market is also gaining a strong foothold across the globe as treating these diseases is becoming increasingly difficult due to the acquired drug resistance. In the light of these developments, research and development activities using structural biology and molecular modeling techniques have been in full swing. The increasing focus on improving the quality of medicines and ensuring patient recovery and safety has augmented the demand for various structural biology and molecular modeling techniques. The demand for these techniques is projected to soar as the need to reduce drug failure is an immense one amongst healthcare institutes.

The report answers questions pertaining to the size of the global market by the end of the forecast period, leading segments, and players amongst others. The report is a comprehensive outlook of the global market and it presents key market insights for readers with absolute objectivity.

Global Structural Biology and Molecular Modeling Techniques Market: Drivers and Trends

The rapid pace of technological developments and innovations have been exceptionally supportive of the global market over the past few years. Both these aspects have authenticated the sophisticated models that help in the accurate determination of cellular interactions and function, which in turn helps in identifying the problem area and a subsequent solution. The wide range of structural biology and molecular modeling techniques are expected to find tremendous scope in the area of drug discovery. These techniques will prove to be important in identifying the missing pieces that limit the process of drug discovery, thereby resulting in high success rates.

Adoption of these techniques in pharmacogenomics and pharmacogenetics are also expected to prove beneficial to the overall growth of the market. Analysts project that increasing incidences of diseases where several drugs cannot be administered to the patient will prove to be a lucrative ground for the global structural biology and molecular modeling techniques market.

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Global Structural Biology and Molecular Modeling Techniques Market: Regional Outlook

Spread over regions such as North America, Asia Pacific, the Middle East and Africa, Europe, and Latin America, the global structural biology and molecular modeling techniques market has truly made its market in North America. The higher understanding of diseases and empathy toward managing them with supportive regulatory policies has been North Americas winning strategy for the past few years. Increasing funding for research and development of novel drugs is expected to favor this regional markets growth in the coming years as well.

On the other hand, increasing expenditure on IT, healthcare infrastructure, and research organizations in Asia Pacific is also expected to open up new avenues for growth for the overall market. Furthermore, the rising standard of living of people in developing countries, improving GDPs, and better access to healthcare are also expected to fuel the demand for structural biology and molecular modeling techniques in Asia Pacific.

Global Structural Biology and Molecular Modeling Techniques Market: Competitive Landscape

The key players identified by the research analysts are Dassault Systemes, Agile Molecule, Acellera Ltd., Bioinformatic LLC, Affymetrix, Agilent Technologies, Inc., Illumina, Bruker Daltonics Inc., Biomax Informatics AG, Chemical Computing Group, and CLC bio. The report points out that the global market is expected to witness intense competition in the coming years. However, to stay ahead of the competition, several players are expected to focus on mergers and acquisitions, investments for novel drug development, and technological advancements.

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TMR Research is a premier provider of customized market research and consulting services to busi-ness entities keen on succeeding in todays supercharged economic climate. Armed with an experi-enced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Structural Biology and Molecular Modeling Techniques Market Size, Application, Region and Growth Forecast 2017-2025 - 3rd Watch News

Westport, CT, June 01, 2020 (GLOBE NEWSWIRE) --

BioSig Technologies, Inc. (Nasdaq: BSGM) (BioSig” or the Company”) and its subsidiary, ViralClear Pharmaceuticals, Inc., today announced that it will host a call to discuss the Phase II clinical trials of merimepodib, its broad-spectrum oral anti-viral candidate for the treatment of COVID-19 in adult patients.

The format will be a management presentation updating recent developments followed by a Q&A session with select call attendees.

Conference Call Details: Date: Tuesday, June 9, 2020 Time: 11:00 AM Eastern Time (ET) Dial in Number for U.S. Callers: 1-877-407-8293 Dial in Number for International Callers: 1-201-689-8349

A replay will be available for two weeks starting on June 9, 2020 at approximately 2:00 PM ET. To access the replay, please dial 1-877-660-6853 in the U.S. and 1-201-612-7415 for international callers. The conference ID# is 13704617.

On May 14, 2020, an article titled, "The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro" was published by F1000 Research, an online peer-reviewed life sciences journal publishing program in biology and medicine. The article cites that merimepodib in combination with remdesivir decreases viral production of SARS-CoV-2 to undetectable levels in pre-clinical testing.

On May 18, 2020, ViralClear announced the FDA’s clearance of its IND to proceed with a proposed Phase II study of merimepodib in COVID-19 patients. The human clinical trial is planned to be conducted under the leadership of Dr. Andrew D. Badley, Professor and Chair of the Department of Molecular Medicine and the Enterprise Chair of the COVID-19 Task Force at Mayo Clinic.

About BioSig Technologies BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

About Merimepodib (MMPD) Merimepodib, a broad-spectrum anti-viral candidate, has demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials conducted (including 315 chronic hepatitis C patients, 24 psoriasis patients, and 98 healthy volunteers) and an extensive preclinical safety package completed.

A manuscript titled, The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro”, was submitted to an online peer-reviewed life sciences journal. This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr. Jerome Zeldis of ViralClear Pharmaceuticals, Inc. (ViralClear”) as a corresponding author. This article highlights pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch.

About ViralClear BioSig’s subsidiary, ViralClear Pharmaceuticals, Inc., is seeking to develop a novel pharmaceutical to treat COVID-19. Merimepodib is intended to be orally administered, and has demonstrated broad-spectrum in vitro antiviral activity, including strong activity against COVID-19 in cell cultures. Merimepodib has been previously studied in 12 clinical trials, including 5 in patients with hepatitis C (1 Phase 1b, 1 Phase 2, 2 Phase 2a, and 1 Phase 2b), 1 in patients with psoriasis (Phase 2), and six in healthy volunteers (Phase I).

Forward-looking Statements This press release contains forward-looking statements.” Such statements may be preceded by the words intends,” may,” will,” plans,” expects,” anticipates,” projects,” predicts,” estimates,” aims,” believes,” hopes,” potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

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ViralClear to Host Conference Call on June 9th to Discuss Upcoming and Recent Developments for Phase II Human Clinical Trials of its Broad-Spectrum...