(AOF) – Sensorion, a pioneering clinical-stage biotechnology company dedicated to the development of innovative therapies to restore, treat and prevent hearing loss, announced that the initiation of a proof-of-concept (POC) clinical trial of SENS -401 (Arazasetron) in patients with cisplatin-induced ototoxicity (CIO) has been approved by regulatory authorities in France.
Cisplatin and other platinum compounds are essential chemotherapeutic agents for the treatment of many cancers. Platinum therapies cause a severe side effect which is permanent and irreversible ototoxicity or hearing loss in 50-60% of adult patients and 90% of pediatric patients who survive cancer. This indication represents a very significant unmet medical need for patients and a large market with more than 500,000 patients concerned in the United States, the European Union and Japan.
Authorization has been granted to start a Phase 2a trial with SENS-401 in the CIO. Following in-depth analysis of the results of the AUDIBLE-S study in early 2022, Sensorion has changed the design of this study to focus on the prevention of hearing loss.
Géraldine Honnet, Medical Director of Sensorion said: “Cisplatin is an essential chemotherapy that saves the lives of millions of cancer patients. Unfortunately, it has a harmful side effect for the majority of cancer survivors who receive this therapy. , which is permanent and irreversible hearing loss. We are pleased to have received approval for our clinical trial with the recently amended SENS-401, which we believe has the potential to preserve hearing in patients receiving cisplatin. . ”
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