Medsenic Publishes an Article in Transplantation and Cellular Therapy, Unveiling High Response Rate and Corticosteroid Sparing With Arsenic Trioxide-based First-line Therapy in cGvHD after allo-HSCT

• First-line combination of arsenic trioxide and prednisone in cGvHD showed an Overall Response Rate (ORR) at 6 months of 75%, allowing rapid corticosteroid tapering.
• Skin and eating disorders significantly improved whereas other dimensions of quality of life did not change.
• In murine models of cGvHD, arsenic trioxide (ATO) increases oxidative stress and regulates T and B cell populations and macrophage polarization.

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).

High response rate and corticosteroid sparing with arsenic trioxide-based first-line therapy in cGvHD after allo-HSCT - Transplantation and Cellular Therapy, Official Publication of the American Society for Transplantation and Cellular Therapy (astctjournal.org)

"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).