- First three patients discharged from Hospital ICU within 8 days from initial IV administration
- No infusion-related adverse events noted for any patient treated to date
GlobeNewswire, January 26, 2021
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today positive preliminary results from its Phase 1b 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). This ongoing study (PSC-CP-004) is a single arm, non-randomized Phase 1b study of the safety and preliminary efficacy of COVI-MSCs administered every other day for three infusions for a total of 1 x 106 cells/kg. The primary objective is to evaluate the safety of intravenous infusion of allogeneic adipose MSC cells in patients with COVID-19-induced ARD or ARDS. The secondary objective is to evaluate efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress.
The first three patients enrolled tolerated treatment well and improved rapidly. Each of the three patients was discharged from the hospital within a week of starting the patient’s COVI-MSC infusions and two patients were discharged on the day of their last infusion. One of the patients had been in the hospital for three weeks, unable to be weaned from significant oxygen support, and another patient with uncontrolled diabetes had been discharged previously but had to be readmitted due to recurrent ARD. Each of the infusions were well-tolerated and no patient reported any infusion-related adverse events. A fourth patient is currently at the beginning of a course of treatment, with no safety issues following the patient’s first infusion. Additional enrollment continues.
Dr. Eyad Almasri, Associate Professor of Medicine, Pulmonary, Critical Care and Sleep Medicine at UCSF Fresno, is the principal investigator in this ongoing study. Dr. Almasri stated, “I am excited to see how well-tolerated this promising treatment is to date and am very encouraged by the early signals we are seeing from the first few patients. I am looking forward to working with Sorrento in continuing to offer COVI-MSC treatments to patients in this study and in the proposed controlled phase 2 study.”
More information on the Phase 1 trial can be found at www.clinicaltrials.gov (NCT04486001). Information on the proposed Phase 2 trial is expected to be available soon.
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: BMC
Personalized Stem Cells, Inc. (PSC) is the GMP manufacturer partner for Sorrento’s COVI-MSC.
Source: Sorrento Therapeutics, Inc.