SAN DIEGO, Oct. 12, 2020 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that it has entered into an exclusive license agreement with Personalized Stem Cells, Inc. (PSC) to acquire global rights to its adipose derived mesenchymal stem cells (MSCs) for patients suffering from acute respiratory distress syndrome (ARDS) associated with COVID-19, which have been cleared for a Phase 1 clinical trial by the FDA.
The study is a single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of an adipose-derived allogeneic MSC product candidate. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients. The primary objective is to evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 and in respiratory distress. The secondary objective is to evaluate a set of safety and efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress.
More information on the Phase 1 trial can be found at:
Sorrento will be assuming responsibility for executing the Phase 1 trial, which is targeted to enroll about 20 hospitalized COVID-19 patients in California. Pending the results of the Phase 1 trial, Sorrento expects to expand into Phase 2 trials in multiple relevant geographies as may be determined in consultation with applicable regulatory authorities.
Stem cells have been demonstrated to support