Sorrento Therapeutics, Inc. Announces Positive Results of Phase 1b Study of COVI-MSC Treatment of ICU Covid-19 Patients, Achieving 100% (10 out 10) Discharge Rate
April 20, 2021 at 09:00 am EDT
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Sorrento Therapeutics, Inc. announced the completion of enrollment in its Phase 1b study of human allogeneic adipose-derived mesenchymal stem cells (COVI-MSC) infusions to treat COVID-19 induced acute respiratory failure (ARD) or acute respiratory distress syndrome (ARDS). This current study (MSC-COV-101) is a single arm, non-randomized Phase 1b study of the safety and preliminary efficacy of COVI-MSCs administered every other day for up to three infusions for a total of 1 x 106 cells/kg, with patients being followed for 28 days following the final infusion. A total of 10 patients (8 males/2 females; age range 24-65 years; 8 Caucasian/2 Asian; 7 Hispanic/Latino/3 non-Hispanic/Latino; height 64 to 70 inches; weight 66 to 130 kg) were enrolled and all were discharged from the hospital to home within three days of their last infusion. At baseline, all patients required oxygen supplementation and had PaO2/FiO2 ratios ranging from 135 to 256 (normal ? 400). All patients had various medical co-morbidities in addition to obesity. The 10th patient had been under treatment for nearly 2 weeks without improvement and was discharged after the 2nd COVI-MSC infusion with oxygen saturations in the high 90s on room air. On follow up days later, the patient was still doing well. The study met its primary objective: to demonstrate the safety of intravenous infusion of allogeneic adipose MSC cells in patients with COVID-19-induced ARD or ARDS. Dr. Eyad Almasri, Associate Professor of Medicine, Pulmonary, Critical Care and Sleep Medicine at UCSF Fresno, is the principal investigator of this study. Sorrento will be working with the FDA in the near future once the full dataset is available to plan a placebo-controlled pivotal study to support an emergency use authorization (EUA) submission. The study is expected to be conducted across multiple sites in the United States and Brazil.
Sorrento Therapeutics, Inc. is a clinical and commercial stage biopharmaceutical company. The Company is engaged in developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune diseases and COVID-19. The Companyâs segments include Sorrento Therapeutics and Scilex. The Sorrento Therapeutics segment is organized around its Immune-Oncology therapeutic area, leveraging its G-MAB antibody library and targeted delivery modalities to generate the next-generation of cancer therapeutics. The Scilex segment is organized around its non-opioid pain management operations and clinical pipeline. The Companyâs immuno-oncology platforms, including its fully human antibodies (G-MAB library), ACEA small molecule library, immuno-cellular therapies (DAR-T), antibody-drug conjugates (ADCs) and oncolytic virus (Seprehvec). The Company is also developing potential antiviral therapies against COVID-19, including FUJOVEE (Abivertinib) and its rapid diagnostic test, including COVIMARK.
Sorrento Therapeutics, Inc. Announces Positive Results of Phase 1b Study of COVI-MSC Treatment of ICU Covid-19 Patients, Achieving 100% (10 out 10) Discharge Rate