We've updated our Privacy Policy to make it clearer how we use your personal data. We use cookies to provide you with a better experience. You can read our Cookie Policy here.


BioSenic Releases Details of Optimized Administration Approach Ahead of Planned Phase 3 Trial of OATO

Two scientists in a lab.
Credit: iStock.
Listen with
Register for free to listen to this article
Thank you. Listen to this article using the player above.

Want to listen to this article for FREE?

Complete the form below to unlock access to ALL audio articles.

Read time: 2 minutes

BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, announces the publication of an open-access article describing an optimized schedule for administration of oral arsenic trioxide (OATO) treatment for chronic graft-versus-host disease (cGvHD), based on an earlier post-hoc analysis of Phase 2 data. The schedule will play an important role in the protocol for BioSenic’s forthcoming pivotal Phase 3 clinical trial.


GvHD is a common occurrence following allogeneic hematopoietic stem cell transplantation, used to treat a range of blood and immune diseases, including several leukaemias and lymphomas. Standard treatment begins with corticosteroids, with mixed outcomes, and those with a chronic form of GvHD may need to continue treatment for years, highlighting the clear unmet need for better treatment. BioSenic previously conducted a Phase 2 clinical trial of intravenous ATO in cGvHD treatment following stem cell transplant, with results showing that the first-line use of ATO and corticosteroids in patients with moderate to severe disease is associated with both a high clinical response rate and less need for corticosteroids.

Want more breaking news?

Subscribe to Technology Networks’ daily newsletter, delivering breaking science news straight to your inbox every day.

Subscribe for FREE

Last year, BioSenic announced the results of an additional, observational post-hoc analysis of the full set of clinical data from the Phase 2 trial, improving the overall understanding of clinical response, safety (SAE/AE related to ATO) and cGVHD severity evolution after short cycle(s) of ATO treatment. It shows that the risk of loss of overall response over time is greater in patients who received only one cycle of ATO since they are in partial or complete remission at week 6 post-treatment compared to patients who received two cycles of second-line treatment. The use of 2 cycles of 4 weeks each, separated by a rest period of 4 weeks on ATO at 0.15mg/kg/day, should be optimal for the future treatment of cGvHD patients. The therapeutic schedule of the upcoming Phase 3 trial will be adapted thanks to a recent advance that allowed for an oral ATO formulation that can be taken at home.


François Rieger, PhD, Chairman and CEO of BioSenic, said: "Our careful analysis of the previous Phase 2 trial clinical data, obtained using a short sequence of administration of ATO to patients affected by chronic graft versus host disease, provides additional guidance for optimizing dosage and treatment timing of ATO. We are now focused on finalizing the submission package of our Phase 3 trial using our new oral formulation for ATO, to further confirm the positive therapeutic effects revealed by our first trial on a limited cohort of patients with moderate-to-severe disease. We are committed to demonstrate the exceptional therapeutic effect of ATO, in line with all previous preclinical and clinical recent data obtained in the field of autoimmunity. It is now clear that the strongest industrial positioning for BioSenic aligns with the recently revealed therapeutic power of arsenic trioxide, the main asset promoted by our company.”


BioSenic is committed to exploiting the immune modulating potential of ATO in new ways for a range of diseases. In oncology, intravenous treatment with ATO has made acute promyelocytic leukaemia (APL) the most curable blood cancer since 2002[1][2]. The company is now introducing an oral formulation of ATO under an exclusive licensing agreement from its partner Phebra for use in a one-month cycle treatment, repeated twice, which will significantly improve patient quality of life and compliance while reducing healthcare costs. BioSenic aims to better address the unmet medical need in cGvHD with this oral, take-at-home formulation, proven in earlier studies on APL patients to be safe and bioavailable compared to an intravenous delivered formulation. In addition, the company is developing other formulations to expand its potential applications into other immune-related disease areas.