Sensorion, a pioneering clinical-stage biotechnology company, announced that the first patient has been enrolled in its phase 2a proof of concept clinical trial of SENS-401 (Arazasetron) in patients suffering from cisplatin-induced ototoxicity.
Cisplatin and other platinum-based compounds are essential chemotherapeutic agents for many cancers. A serious side effect of these therapies is ototoxicity, or permanent and irreversible hearing loss, which occurs in up to 50-60% of adult patients and 90% of paediatric patients who survive cancer. This indication represents a very significant unmet need for patients and is a large potential market with an estimated incidence of more than 500,000 patients in the United States, the European Union and Japan.
The exploratory phase 2a, multicenter, randomized, controlled, open-label study, NOTOXIS, aims at evaluating the efficacy of SENS-401 to prevent ototoxicity induced by cisplatin in adult patients with a neoplastic disease.