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Ampio Receives feedback from the FDA on Ampio s Proposed Modifications to the special protocol asses

Search jobs 29-Dec-2020 Ampio Receives feedback from the FDA on Ampio s Proposed Modifications to the special protocol assessment for Ampion treatment of severe Osteoarthritis of the knee ENGLEWOOD, Colo., Dec. 29, 2020 /PRNewswire/ Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, announced today it has received guidance from the U.S Food & Drug Administration ( FDA ) regarding the impact of COVID-19 on its Phase III clinical trial for osteoarthritis of the knee ( OAK ). The COVID-19 health emergency has impacted clinical trials, with over 1,000 studies suspended as a result of the pandemic, including the Phase III clinical trial ( AP-013 ) for the intra-articular injection of Ampion for treatment of severe OAK. The AP-013 study is being conducted under a Special Protocol Assessment ( SPA ) which provides a

Ampion Demonstrates Safety In COVID-19 Patients And Initiates Global Clinical Trial For Intravenous Ampion

Share this article Share this article ENGLEWOOD, Colo., Dec. 17, 2020 /PRNewswire/  Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology based therapies for prevalent inflammatory conditions, announced today it has completed its Phase I clinical trial and has initiated the first steps for a global Phase II clinical trial for intravenous ( IV ) Ampion treatment in COVID-19 patients. The Phase I study was a randomized, controlled study of adults hospitalized with severe COVID-19. The primary endpoint for the study was evaluated after a 5-day treatment period, and safety was followed for an additional 3 months. Half of the patients received IV Ampion plus the standard of care ( SOC ) for COVID-19 while the other half received SOC alone. The following highlights were observed:

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