COVID-19 Top News – March 30, 2020

March 30, 2020

Coronavirus Therapy / Cocrystal Pharma
Cocrystal Pharma reports 2019 financial results and outlines expected value-driving milestones for 2020 (GlobeNewswire, Cocrystal Pharma, Inc.) – Mar 30, 2020 – “Advancing preclinical COVID-19 Coronavirus program leveraging patent rights recently acquired from Kansas State University Research Foundation (“KSURF”)….Q2 2020: File patent application….Q2/Q3 2020: Develop COVID-19 inhibitors using proprietary platform technology….H2 2020: Initiate preclinical studies of COVID-19 inhibitors.”


Kevzara (sarilumab) / Asahi Kasei, Regeneron, Sanofi
Sanofi: First patient outside U.S. treated in global Kevzara (sarilumab) clinical trial program for patients with severe Covid-19 (GlobeNewswire) – Mar 30, 2020 – “The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the United States – all countries that have been impacted by COVID-19….This is the second multi-center, double-blind, Phase 2/3 trial as part of the Kevzara COVID-19 program….The trial outside of the U.S. will assess the safety and efficacy of adding a single intravenous dose of Kevzara to usual supportive care, compared to supportive care plus placebo. The trial has an adaptive design with two parts and is anticipated to enroll approximately 300 patients.”


GC LabCell to develop Covid-19 treatment using NK-cell (Korea Biomedical Review) – Mar 30, 2020 – “Green Cross LabCell said that it has begun research into a COVID-19 medication, with a hope to start a clinical trial by the second half of 2020 in Korea and the United States….The company will begin to develop the COVID-19 treatment through a joint study with a biotechnology company, KLEO Pharmaceuticals….One of them is to develop a COVID-19 treatment with its NK cell therapy….The other one uses ARMs, which acts as a neutralizing antibody of NK treatment, to develop COVID-19 treatment. The companies will conduct the research with the National Institute of Allergy and Infectious Disease of the National Institutes of Health and a research team led by Choi Young-ki of the Chungbuk National University College of Medicine.”


hydroxychloroquine / Generic mfg.; chloroquine phosphate / Generic mfg.
FDA issues emergency use authorization of Trump-touted drug to treat coronavirus (The Daily Wire) – Mar 30, 2020 – “Food and Drug Administration (FDA) issued an emergency use authorization for hydroxychloroquine and chloroquine…in the fight against the China-originated novel coronavirus….The United States Department of Health & Human Services (HHS) announced in a statement…that the FDA will allow the drugs to be ‘donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible,’ a Politico report said.”


IMV Inc. provides updates on the development of DPX-COVID-19 vaccine and ongoing business and clinical operations (Businesswire) – Mar 30, 2020 – “In collaboration with Gary Kobinger, Ph.D….preclinical assays in animal models are also planned in April through May of this year….In collaboration with Joanne Langley, M.D. at the Canadian Center for Vaccinology (CCfV) and the Canadian Immunization Research Network (CIRN) the design of a Phase 1 clinical study in 48 healthy subjects has been completed and clinical sites identified in both Nova Scotia and Quebec. IMV has initiated discussions with Health Canada in preparation for a Clinical Trial Application (CTA). A meeting is being scheduled in the week of April 20, 2020 with the goal to initiate the clinical study in the summer of 2020.”


bucillamine / Revive Therap
Revive Therapeutics provides corporate update on its covid-19 and infectious diseases programs (GlobeNewswire, Revive Therapeutics Ltd.) – Mar 30, 2020 – “The Company is finalizing its regulatory package and clinical study plan for Bucillamine in the treatment of COVID-19 and it will submit for regulatory approval, by way of an IND application submission to the U.S. FDA, to investigate Bucillamine in a proposed Phase 2 clinical study. Revive will also seek to expand the clinical investigation of Bucillamine for COVID-19 in APAC regions, with a particular interest in Japan and South Korea.”


AdCOVID (COVID-19 vaccine) / Altimmune
Altimmune and the University of Alabama at Birmingham to collaborate on development of single-dose, intranasal Covid-19 vaccine (GlobeNewswire, Altimmune, Inc.) – Mar 30, 2020 – “Altimmune, Inc….today announced that it is launching a collaboration with the University of Alabama at Birmingham (UAB) on the development of its single-dose, intranasal COVID-19 vaccine, named AdCOVID. In response to the urgent demand posed by the COVID-19 global pandemic, Altimmune has created a COVID-19 vaccine candidate and is currently preparing for immunogenicity studies and manufacture of Phase 1 clinical trial material. Initially, Altimmune will work with UAB investigators on preclinical animal studies and characterization of the vaccine immunogenicity with the goal of enabling a Phase 1 trial in Q3 of this year.”


Avigan (favipiravir) / Fujifilm Holdings
Russia now has three drugs that can help treat Covid-19 – Russian Academy of Sciences (UrduPoint) – Mar 30, 2020 – “Three antiviral drugs that can be used to treat COVID-19 were developed in Russia…Chekhonin stated that the antiviral drug triazavirin was created several years ago…now being tested by Chinese scientists for its ability to treat COVID-19….The leading academician also stated that another drug, based on the Japanese-made antiviral treatment favipiravir….Another viral drug, fortepren, has also passed clinical trials and should be assessed for its ability to treat COVID-19, the academician stated.”


Coronavirus Vaccine / J&J, Beth Israel Deaconess Medical Center
Johnson & Johnson announces a lead vaccine candidate for Covid-19; Landmark new partnership with U.S. Department of Health & Human Services; And commitment to supply one billion vaccines worldwide for emergency pandemic use (PRNewswire) – Mar 30, 2020 – “Johnson & Johnson…today announced the selection of a lead COVID-19 vaccine candidate from constructs….The significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA)….The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021…”


FDA warns against use of Prodex-B as antiviral treatment for Covid-19 (GMA News) – Mar 30, 2020 – “The Food and Drug Administration (FDA)…warned the public against the use of Prodex-B as an antiviral treatment for coronavirus disease 2019 (COVID-19). In an advisory, the FDA said the drug cocktail composed of Procaine, Dexamethasone, and Vitamin B is not registered. The use of such unregistered drug may harm the patient, it added….Earlier in the day, the Department of Health also warned that other approved off-label drugs for COVID-19 treatment shall only be administered at hospitals and shall not be used for self-medication.”


Pluristem treated first three Covid-19 patients in Israel under compassionate use (GlobeNewswire, Pluristem Therapeutics, Inc.) – Mar 30, 2020 – “Company is in discussions with regulators in the U.S. and Europe to define its clinical strategy for COVID-19….Pluristem Therapeutics Inc….it has dosed three patients in two different hospitals in Israel under a compassionate use program for the treatment of COVID-19, as approved by the Israeli Ministry of Health. Pluristem expects to enroll additional patients in Israel in the coming days and anticipates providing updates on clinical outcomes once significant data has been gathered.””

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