Palm Beach, FL – May 1, 2020 – America’s public-private sector collaboration on the global health crisis appears to have borne fruit… very quickly. The government has streamlined regulations and the public sector has responded with unheard of speed. On April 29 White House health advisor Dr. Anthony Fauci said that data from a coronavirus drug trial testing Gilead Sciences’ antiviral drug remdesivir showed “quite good news” and sets a new standard of care for Covid-19 patients. Speaking to reporters from the White House, Fauci said he was told data from the trial showed a “clear-cut positive effect in diminishing time to recover.” Said a report on CNBC. Fauci said the median time of recovery for patients taking the drug was 11 days, compared with 15 days in the placebo group. He said the mortality benefit of remdesivir “has not yet reached statistical significance.” The results suggested a survival benefit, with a mortality rate of 8% for the group receiving remdesivir versus 11.6% for the placebo group, according to a statement from the National Institutes of Health released later Wednesday. Active healthcare stocks in news today include: BioSig Technologies, Inc. (NASDAQ: BSGM), Gilead Sciences, Inc. (NASDAQ: GILD), CytoDyn Inc. (OTCQB: CYDY), AstraZeneca PLC (NYSE: AZN), Mesoblast Limited (NASDAQ: MESO).
“This will be the standard of care,” Fauci, director of the National Institute of Allergy and Infectious Diseases, added. “When you know a drug works, you have to let people in the placebo group know so they can take it… What it has proven is a drug can block this virus,” he said. U.S. health officials are expected to release the full results of a drug trial conducted by the National Institute of Allergy and Infectious Diseases later Wednesday. Gilead Sciences announced earlier in the day that the study had met its primary endpoint but did not provide further details.
The FDA, in the meantime, has been in “sustained and ongoing” discussions with Gilead to make remdesivir available to Covid-19 patients “as quickly as possible, as appropriate,” said FDA senior advisor Michael Felberbaum.
BioSig Technologies, Inc. (NASDAQ:BSGM) BREAKING NEWS – ViralClear Submits In Vitro Data on Merimepodib and Remdesivir Synergistic Activity Against the COVID-19 Novel Coronavirus to a Peer-Reviewed Journal – BioSig Technologies, this week announced that 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 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. The work was started with Trek Therapeutics and after merimepodib was acquired by ViralClear continued with ViralClear.
“The concentrations of merimepodib and remdesivir used in this article are achievable by our oral merimepodib and intravenous remdesivir.” said Dr. Zeldis, ViralClear’s Executive Chair and co-founder. “We look forward to starting our first Phase II clinical trial with merimepodid in COVID-19 patients upon receipt of FDA permission.”
Merimepodib, a broad-spectrum anti-viral candidate, demonstrated strong activity against COVID-19 in cell cultures in laboratory testing. The molecule is currently undergoing extensive pre-clinical antiviral testing. Upon receipt of FDA permission of its IND, ViralClear intends to pursue development of this molecule for the treatment of COVID-19 through clinical trials in Q2 2020.
Remdesivir is an adenosine analogue that displays broad-spectrum antiviral activity against RNA viruses and has been developed by Gilead Pharmaceuticals for the treatment of Ebola. Recent evidence is mounting for this clinical activity of Remdesivir for treating COVID-19 patients. Read more news for BSGM by visiting: https://ir.biosig.com/press-releases
Also read an article recently published interviewing the BioSig Technologies CEO with regards to ViralClear Developments: https://www.benzinga.com/general/biotech/20/04/15897608/biosigs-ceo-on-why-the-medtech-company-bought-an-antiviral-candidate-to-fight-coronavirus-this-dr
In other healthcare news of note:
Gilead Sciences, Inc. (NASDAQ: GILD) recently announced topline results from the open-label, Phase 3 SIMPLE trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalized patients with severe manifestations of COVID-19 disease. The study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course (Odds Ratio: 0.75 [95% CI 0.51 – 1.12] on Day 14). No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.
“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”
CytoDyn Inc. (OTCQB: CYDY) recently announced updates on 49 COVID-19 patients who have received leronlimab under the U.S. Food and Drug Administration’s (FDA) emergency Investigational New Drug (eIND) program.
Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostics company and an advisor to CytoDyn, expanded on these findings by stating, “We are excited that patients are responding extremely well to leronlimab as expected from the novel mechanism of COVID-19 pathogenesis we discovered and will be reporting in the coming days.”
AstraZeneca PLC (NYSE: AZN) and the University of Oxford reportedly have teamed up to develop and manufacture a coronavirus vaccine, with the goal of producing as many as 100 million doses by the end of 202, if it’s proven to work.
The Financial Times reported the company and the university have struck a deal where AstraZeneca will be responsible for the development and worldwide manufacturing and distribution of the vaccine, known as ChAdOx1 nCov-19.
Currently being developed by Oxford, the vaccine candidate entered phase-one testing last week, the FT reported, with data potentially available as early as next month. If successful, clinical-stage trials would potentially take place by the middle of this year.
Mesoblast Limited (NASDAQ: MESO) a global leader in cellular medicines for inflammatory diseases, recently announced a Phase 2/3 randomized, placebo-controlled trial to rigorously confirm whether its allogeneic mesenchymal stem cell therapy remestemcel-L provides a survival benefit in moderate/severe acute respiratory distress syndrome (ARDS) due to COVID-19 has commenced enrollment.
More than 20 medical centers across the United States will participate in the trial which is expected to complete enrollment within three to four months, with interim analyses planned which could result in stopping the trial early for efficacy or futility.
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