December 8, 2020 -- Citius Pharmaceuticals subsidiary NoveCite has released data from a proof-of-concept large animal study of its proprietary induced mesenchymal stem cell (i-MSC) therapy for acute inflammatory respiratory conditions including acute respiratory distress syndrome (ARDS) related to COVID-19 disease.
The results of the study show improvement in clinical parameters such as oxygenation, less systemic shock, and reduced lung injury compared to the control group. The therapy is believed to secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with ARDS in patients with COVID-19. The allogenic MSC product exhibits superior potency and high cell viability in vitro.
NoveCite's mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell line generated using a proprietary messenger RNA-based (nonviral) reprogramming process. The product's process of robust expansion of uniform MSCs overcomes challenges with human donor-derived MSCs, according to the company.
Citius previously signed an exclusive worldwide licensing agreement with Novellus Therapeutics to develop and commercialize Novellus' i-MSC platform. To execute the agreement, Citius established NoveCite to develop, manufacture, and commercialize the therapies.
NoveCite has already filed a preinvestigational new drug application with the U.S. Food and Drug Administration and has received feedback from the agency.