Sorrento Therapeutics, Inc. announced 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.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento’s multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVIGUARD™, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.
Sorrento’s commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica.