Otonomy, a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, has announced the enrollment of the first patients in a phase 2 clinical trial evaluating OTO-104 for the prevention of hearing loss in cancer patients undergoing chemotherapy with platinum-based agents. This multicenter trial is designed to assess the feasibility, safety and exploratory efficacy of OTO-104 given by intratympanic administration in subjects at risk for Ototoxicity from cisplatin chemotherapy.
“The clinical evaluation of OTO-104 for the prevention of cisplatin-induced hearing loss is a priority for us based on the high unmet medical need, especially in the pediatric and young adult patient populations where hearing is essential to speech development, learning and socialization,” said David A. Weber, Ph.D., president and chief executive officer of Otonomy. “The preclinical proof-of-concept study we published last year provides support for the protective effects of OTO-104 when administered prior to both acute and repeat administration of cisplatin.”
The phase 2 trial is expected to enroll up to 60 subjects at 8-10 leading oncology centers in the United States. Patients will receive an administration of OTO-104 in one ear prior to each of the first three cisplatin treatment cycles, with the contralateral ear as an untreated control. Safety and hearing will be assessed throughout the trial.
This study is part of a broader development program for OTO-104 as a treatment of various severe balance and hearing disorders. Otonomy is also conducting two phase 3 clinical trials for OTO-104 in Ménière's disease patients, with results expected in the second half of 2017.