STRASBOURG, France–(BUSINESS WIRE)–Medsenic, a clinical stage biopharmaceutical company focusing on the discovery and development of new indications and formulations of arsenic salts for the treatment of severe autoimmune diseases, announced today a new publication in Transplantation and Cellular Therapy, – the official Journal of ASTCT (American Society for Transplantation and Cellular Therapy) – that provides insights from its drug Arscimed®, a GMP intravenous formulation of arsenic trioxide, in patients with Chronic Graft Versus Host Disease (cGvHD).
“This Phase II study shows a growing body of data demonstrating the robust response generated by the first-line combination of our arsenic product Arscimed and corticosteroids and how it is associated with a high clinical response rate and rapid CS sparing in cGvHD after previous allo-HSCT. These excellent results are a promising step forward to the management of patients with cGvHD, a rare, complex and extremely debilitating autoimmune disease affecting over 40,000 people worldwide and for which there is no satisfactory treatment. We look forward to confirming its efficacy in a Phase III study as well as its significant impact on improving the quality of life of cGvHD patients” said Prof. François Rieger, President and co-founder of Medsenic.
The primary endpoint of this prospective Phase II multicentre, non-randomised study was the improvement of treatment response, i.e., complete or partial disease remission 6 months after cGvHD diagnosis, with the active ingredient ATO in combination with prednisone, with or without cyclosporine.
Back in May 2022, Medsenic received positive pre-IND response from FDA to initiate a Phase III Clinical Study in cGvHD, with an oral formulation of ATO (OATO, chosen commercial name: ArsciCor).
