FDA Authorizes Athersys to Initiate a Pivotal Clinical Trial Evaluating MultiStem® Cell Therapy in Patients With COVID-19 Induced Acute Respiratory Distress Syndrome
Athersys, Inc. (ATHX)
Last athersys, inc. earnings: 11/6 04:05 pm
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Source: Business Wire
In a Phase 1/2 study of MultiStem therapy for the treatment of ARDS, favorable tolerability data and meaningful potential benefits in mortality, ventilator-free days and ICU-free days observedCompany plans to initiate a Phase 2/3 pivotal study in patients with COVID-19 induced ARDS this quarterAdvancement of key Athersys program with FDA Fast Track designation for the treatment of ARDS CLEVELAND--(BUSINESS WIRE)--Athersys, Inc. (NASDAQ: ATHX) announced today that the U.S. Food and Drug Administration (FDA) has authorized the Company to initiate a Phase 2/3 pivotal study to assess the safety and efficacy of MultiStem® therapy in subjects with moderate to severe acute respiratory distress syndrome (ARDS) induced by the novel coronavirus disease (COVID-19). This program falls under the current Investigational New Drug (IND) application for the Company’s completed MUST-ARDS study and, therefore, a new IND does not need to be filed. The Company plans to open the first clinical sites fo
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