Medsenic SAS, a biopharmaceutical company dedicated to the treatment of autoimmune diseases with arsenic derivatives, announces that it is now holding the authorization from ANSM (French National Security Agency for Medicines and Health Products) to start a Phase II clinical study for the treatment of chronic graft vs host disease (cGvHD). The company has also obtained an Orphan Drug Designation (ODD) for this indication from the European Medicines Agency (EMA).
François Rieger, Medsenic CEO, states:”This approval from ANSM is a necessary regulatory milestone to launch our phase II for the cGvHD, which is a key study for our development. The positive answer from the EMA to grant the Orphan Drug Designation for the cGvHD is also a further leap forward, with extended industrial and trade protection.”
Pr Mohammad Mohty, Head of the Haematology and Cell Therapy Service at the Saint-Antoine hospital and Principal Investigator of the study comments:”Patients and clinicians are waiting for the proper treatment and everything is done to progress in the struggle against the cGvHD. Pre-clinical data obtained by Medsenic have opened up new treatment opportunities and I am eager to begin the first patients’ enrolment.”
Medsenic develops arsenic trioxide-based medicines for the treatment of autoimmune diseases, specifically cGvHD, after a first success in a Phase 2a trial on systemic lupus erythematosus patients. The very encouraging results of this study were presented at the San Francisco ACR congress in November 2015.
About the cGvHD (chronic graft vs. host disease)
This disease occurs after an allogeneic hematopoietic stem cells transplant, when donor’s healthy stem cells – called graft – trigger an immune response against recipient’s cells – called host. Graft’s cells see host’s cells as foreign cells and begin to destroy them. Donor’s T-lymphocytes then attack host’s organs and tissues. There is no effective therapy at this time. Medsenic as thus sets its mission to find a remedy for this life-threatening disease and, doing so, to fulfill a critical and unmet medical need.
About Medsenic
Medsenic, a young and innovative company, was founded in 2010 by Prof. François Rieger and Véronique Pomi-Schneiter. François Rieger, CEO, is a CNRS-1st class former research director and author of more than 170 international scientific publications. Véronique Pomi-Schneiter, Executive Director, was the founder and managing director of ARC Consulting, a strategy, communication and human resources consulting firm. Medsenic innovates and exploits the new opportunities offered by the therapeutic use of arsenic trioxide for the treatment of autoimmune diseases. Its high-level scientific council is chaired by Jules Hoffman – Nobel Prize for Medicine. The company, already supported by private investors, has accelerated its development in 2016 with the arrival of professional investors: Capital Grand Est, Fa Dièse and Fist SA, a CNRS subsidiary. This allows the launch a Phase II human clinical study for the treatment of chronic graft vs. host orphan disease (cGvHD).
Contact: Véronique Pomi-Schneiter, Executive Director – 06 35 46 32 66 veronique.pomi@medsenic.com www.medsenic.com
Source: Mesenic