BioSenic S.A. announced the final results of a new, detailed post-hoc analysis of the Company's previous Phase 2 clinical trial of ATO for the first-line curative treatment of cGvHD. The analysis will be used to determine the optimal posology of therapeutic oral ATO administration for BioSenic's upcoming clinical trial(s) and will be submitted for peer review prior to preparation of the necessary regulatory filings for trial approvals. BioSenic's new in-depth post-hoc clinical analysis of the Phase 2 clinical data now shows that in the group of patients who did not respond after first so-called induction cycle, more patients (20%) responded after a consolidation cycle of treatment.

As a result, BioSenic will continue to use this 2-cycle, time-limited regimen. This will consist of a double four-week course. In addition, BioSenic has determined that an increase in the number of weekly injections over a four-week course could significantly increase the positive effect of the treatment on the biological and cellular parameters of the disease, consistent with a full effect of the drug at levels determined to be very safe for patients.

BioSenic's goal is to finally select the best conditions for administering effective and safe doses of arsenic trioxide to achieve a convincing curative treatment of cGvHD, for which there is currently no alternative effective long-term therapy. In the field of oncology, intravenous (IV) ATO has been accepted as a first-line treatment for acute promyelocytic leukemia (APL) since 2002, with demonstrated safety and long-term remissions. Until now, ATO in APL has been administered daily by IV infusion for up to or more than one hundred cumulative doses.

IV administration requires hospitalization, is inconvenient for patients, results in reduced quality of life and is expensive. The anticipated introduction of an oral formulation of ATO in 2 cycles of four full weeks each, corresponding to an optimal dosing regimen, will significantly improve patient quality of life and compliance while reducing healthcare costs. This will be the next achievement in BioSenic's broader goal to contribute improved and potentially curative treatments for an autoimmune disease for which there are currently no satisfactory medical solutions.