Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today the start of enrollment in its Phase 2 efficacy study of human allogeneic adipose-derived mesenchymal stem cells (COVI-MSC™) for patients suffering from COVID-19-induced acute respiratory distress (ARD) or acute respiratory distress syndrome (ARDS) in Brazil.
This study (MSC-COV-202BR) is a multi-arm, randomized, placebo-controlled Phase 2 study of the efficacy and safety of three infusions of COVI-MSC administered on varying schedules in the setting of standard of care treatments for COVID-19 in 100 subjects. The primary objective of this study is to evaluate the efficacy of COVI-MSCs in patients with COVID-19-induced ARD or ARDS.
Additionally, Sorrento will soon begin enrollment for two additional Phase 2 studies with COVI-MSC:
- A parallel Phase 2 placebo-controlled Phase 2 safety study to be conducted across multiple sites in the United States.
- A pulmonary long-hauler Phase 2 safety and efficacy study across multiple sites in Brazil.
Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, stated, “It brings us great pleasure to see our MSC treatments for COVID-19-induced ARD/ARDS and post-COVID pulmonary long-haul syndrome rapidly move forward in clinical trials and towards a potential emergency approval of this promising therapy globally. We believe that COVI-MSC can help save lives, which is our primary goal at Sorrento.”
More information on the three Phase 2 trials can be found at www.clinicaltrials.gov (NCT04903327, NCT04905836 and NCT04992247).
Mesenchymal stem cells have been demonstrated to support resolution of symptoms in multiple disease settings and have the potential to reduce the long-term effects associated with pulmonary tissue damage. More information on the potential use and benefits of MSCs for patients with COVID-19 can be found in the recently published review at: https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02380-2.
Personalized Stem Cells, Inc. (PSC) is Sorrento’s GMP manufacturing partner for COVI-MSC.