Lately, it seems, we are sharing updates regarding the COVID-19 cell therapy product and clinical trial every other week. The developments seem to be coming at a breakneck speed, as is warranted when faced with a crisis like the COVID-19 pandemic. Our latest news comes from Brazil, a country that has seen one of the highest death rates as a result of COVID-19.
COVID-19 Stem Cell Clinical Trial
As many of you know, Personalized Stem Cells developed a cell therapy candidate for COVID-19 and procured FDA approval for a phase 1b clinical trial. We then outlicensed it to Sorrento Therapeutics who recently completed the first clinical trial. Preliminary safety and efficacy results were very promising. Ten patients who were hospitalized and required oxygen supplementation, were all discharged from the hospital shortly after completing treatment with stem cells. In addition, there were no infusion related adverse events reported in any of the patients. These promising results helped secure approval for the Phase 2 study in Brazil.
Brazilian Approval of COVID-19 Phase 2 Clinical Trial
The Brazilian Health Regulatory Agency (Anvisa) recently authorized a Phase 2 COVID-19 stem cell clinical trial. This trial will be a pivotal, multi-center, randomized, controlled study to evaluate the safety and efficacy of allogeneic mesenchymal stem cell therapy for the treatment of COVID-19 induced acute respiratory distress syndrome (ARDS). Sorrento expects to enroll 100 patients in the new study, with 33 placebo and 67 treated patients. The stem cell treatments will be administered every other day for a total of three infusions.
Sorrento Therapeutics expects that results from the Phase 2 clinical trial will mimic the successful results seen in the Phase 1b study. If that is the case, Sorrento plans to take the steps necessary to move the cell therapy candidate from the clinical trials stage to Emergency Use Authorization, in an effort to make this therapy more accessible to those suffering from COVID-19 induced ARDS.