Brazilian Health Regulatory Agency (ANVISA) Authorizes Sorrento Phase 2 Pivotal Clinical Trial of COVI-MSC™ in Hospitalized COVID-19 Patients With Acute Respiratory Distress Syndrome
Brazil Phase 2 Pivotal clinical trial of COVI-MSC is now authorized to proceed.The study will compare therapy using mesenchymal stem cells to placebo (and standard of care) in 100 COVID-19 patients hospitalized due to acute respiratory distress syndrome (ARDS).Given the emergency status in Brazil, Sorrento has worked with ANVISA to obtain fast turn-around for the Phase 2 Pivotal clinical trial submission following positive Phase 1b results in the U.S.Maintaining an extreme sense of urgency, Sorrento anticipates commencing enrollment of patients in the study in June 2021. SAN DIEGO, May 20, 202...
Source: yahoo.com