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CD24Fc / OncoImmuneOncoImmune receives FDA approval for Covid-19 clinical trial (PipelineReview) - Apr 9, 2020 - "OncoImmune, Inc. has received a study-may-proceed letter from the FDA for its Phase III clinical trial testing the safety and efficacy of CD24Fc for the treatment of hospitalized COVID-19 patients (SAC-COVID). A cohort of 230 subjects with severe clinical symptoms will be randomized and administered a single dose of CD24Fc (480 mg IV infusion) or placebo and followed for a 14-day period to assess safety and efficacy in clinical improvement. The SAC-COVID trial consists of two interim analyses, respectively, for safety and therapeutic activity, and for therapeutic efficacy. This is a double blind, randomized, multi-center clinical trial."Actemra IV (tocilizumab) / Roche, JW PharmaChugai starts phase III clinical trial of Actemra for Covid-19 pneumonia in Japan (Chugai Press Release) - Apr 8, 2020 - "Chugai Pharmaceutical Co., Ltd....announced that it is working to start a Phase III clinical trial in Japan with the humanized anti-human IL-6 receptor monoclonal antibody, “Actemra® Intravenous Infusion 80 mg, 200 mg, and 400 mg” [generic name: tocilizumab (genetical recombination)] in COVID-19 pneumonia. Chugai filed a clinical trial notification with the Pharmaceuticals and Medical Devices Agency today to conduct a Phase III clinical trial of Actemra for the treatment of hospitalized patients with severe COVID-19 pneumonia in Japan. It is working to start enrolling as soon as possible after finalizing study details."ifenprodil (NP-120) / Algernon PharmaAlgernon Announces Positive Feedback from Health Canada for Ifenprodil Covid-19 Phase 2 Human Trial (GlobeNewswire, Algernon Pharmaceuticals) - Apr 8, 2020 - "Algernon Pharmaceuticals Inc....is pleased to announce that it has received positive feedback from Health Canada on the Company’s plan to conduct a phase 2 COVID-19 clinical study in Canada, with its repurposed drug NP-120 (Ifenprodil). The Company believes that Ifenprodil is a drug that could reduce both the severity and duration of a COVID-19 infection....In addition to advancing Ifenprodil towards a human trial approval in Canada, the Company is also working to support a planned investigator-led Ifenprodil COVID-19 clinical trial in South Korea, a sponsored trial in Australia and has also filed a pre-IND application for a phase 2 COVID-19 clinical trial with the U.S. FDA."NVX-CoV2373 / NovavaxNovavax Identifies Coronavirus Vaccine Candidate; Accelerates Initiation of First-in-Human Trial to Mid-May (GlobeNewswire, Novavax, Inc.) - Apr 8, 2020 - "Novavax, Inc....today announced it has identified a coronavirus vaccine candidate, NVX-CoV2373, a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology, and will initiate a first-in-human trial in mid-May....'NVX-CoV2373 produces high levels of neutralizing antibodies against SARS-CoV-2 in animal studies'....The NVX-CoV2373 clinical development plan combines a Phase 1/Phase 2 approach....The Phase 1 clinical trial is a placebo-controlled observer blinded study of ~130 healthy adults and includes assessment of dosage amount and number of vaccinations. The trial is expected to begin in mid-May with preliminary immunogenicity and safety results in July....Novavax entered into an agreement with Emergent BioSolutions to provide contract development and manufacturing services, supplying Novavax with GMP vaccine product for use in its clinical trials."Elpida (elsulfavirine) / ViriomViriom initiates phase 2 clinical study of elsulfavirine for treatment of Covid-19 (PRNewswire) - Apr 8, 2020 - "Viriom, Inc. today announced the initiation of a Phase 2 clinical study to evaluate the efficacy of elsulfavirine in adults with moderate manifestations of COVID-19 (novel coronavirus). This randomized, open-label, multicenter study will enroll approximately 240 patients at medical centers primarily across Russia and EAEU countries, as well as other countries globally with high numbers of diagnosed cases, beginning in May....The new clinical study expands the ongoing research into elsulfavirine..."Ryoncil (remestemcel-L) / Mallinckrodt, Mesoblast, JCR PharmaMesoblast partners with the cardiothoracic surgical trials network established by the U.S. National Institutes of Health’s National Heart, lung and Blood Institute to conduct randomized controlled trial of remestemcel-l for patients with acute respiratory distress syndrome due to Covid-19 (GlobeNewswire, Mesoblast Limited) - Apr 8, 2020 - "Mesoblast Limited...today announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials. Mesoblast...will provide investigational product for the trial."trabedersen (OT-101) / Autotelic, Mateon TherapeuticsMateon Achieves Milestone in its Development of OT-101, a Phase 3 Clinical Drug Candidate, Against COVID-19 (GlobeNewswire, Mateon Therapeutics) - Apr 6, 2020 - "Mateon Therapeutics, Inc....announced today that Mateon has delivered the requisite testing results to Golden Mountain Partners (GMP) confirming the applicability and potential use of OT-101 for the treatment of COVID-19. OT-101 exhibited potent activity against both COVID-19 and SARS with a robust safety index of >500....Mateon has submitted a Pre-Investigational New Drug (Pre-IND) application package to the Food and Drug Administration to allow the referencing of OT-101’s oncology IND in order to streamline the IND submission for OT-101 against COVID-19."Hope Biosciences receives FDA approval to commence first stem cell clinical trial for protection against Covid-19 (Odessa American) - Apr 6, 2020 - "Hope Biosciences...today announced that FDA has approved a Phase II clinical trial evaluating efficacy and safety of Hope Biosciences’ autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) to provide immune support against COVID-19....In COVID-19 patients, inflammation is a driving force behind disease progression, and it is critical to regulate the immune system as early as possible."Luminex receives FDA emergency use authorization for ARIES SARS-CoV-2 assay to detect virus responsible for Covid-19 disease (PRNewswire) - Apr 6, 2020 - "Luminex Corporation...today announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its ARIES® SARS-CoV-2 Assay for rapid detection of the virus that causes COVID-19. The assay runs on the ARIES® System, an FDA-cleared, sample-to-answer, automated, on-demand molecular diagnostic platform. The system is capable of running up to 144 tests per day, requiring no specialty training and minimal human interaction."WHO says coronavirus vaccine and treatment research has ‘accelerated at incredible speed’ (cnbc) - Apr 6, 2020 - "Research to develop vaccines and treatments to fight the coronavirus has 'accelerated at incredible speed,'...Dr. Tedros Adhanom Ghebreyesus said Monday....'The viral genome was mapped in early January and shared globally which enabled tests to be developed and vaccine research to start,' Tedros said at a news conference at WHO headquarters in Geneva."
