SAN DIEGO, CALIFORNIA — Otonomy, Inc., a US-based biopharmaceutical firm, announced the enrollment of its first patients in a Phase 2 clinical trial evaluating OTO-104 for prevention of hearing loss in cancer patients undergoing chemotherapy with platinum-based agents, such as cisplatin. This multicenter trial is designed to evaluate the feasibility, safety and efficacy of OTO-104, through intratympanic administration, in subjects at risk for ototoxicity from cisplatin chemotherapy.
OTO-104, a sustained-exposure formulation of the steroid dexamethasone, has already been under investigation by the company for addressing Ménière’s disease symptoms, which include acute vertigo attacks, tinnitus, fluctuating hearing loss and feelings of of aural fullness.
This latest study, says the company, is part of a broader development program for OTO-104 to treat severe balance and hearing disorders. Otonomy is also in the process of conducting two Phase 3 clinical trials for OTO-104 in Ménière’s disease patients, with results expected in the second half of 2017.
“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. 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.” –David A. Weber, Ph.D., Otonomy President and CEO
According to the company, the Phase 2 trial will 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.