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.
Otonomy president and CEO David Weber said: “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.”
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.
About Cisplatin-Induced Hearing Loss
Cisplatin and other platinum-based chemotherapeutic agents are routinely used in treating numerous tumor types with approximately 500,000 patients including 2,000 children treated each year in the United States. While the use of platinum agents has contributed to improved patient survival, ototoxicity and associated permanent hearing loss is well documented in the clinical literature.
In particular, hearing loss has been reported in up to 90% of children and young adults treated with platinum-based agents. This adversely affects speech and language development and has been associated with academic and social difficulties. At this time, there is no FDA-approved drug treatment to protect against platinum-based ototoxicity.
About OTO-104
OTO-104 is a sustained-exposure formulation of the steroid dexamethasone in development for the treatment of various severe balance and hearing disorders. The first indication being pursued is Ménière's disease, which is a chronic condition characterized by acute vertigo attacks, tinnitus, fluctuating hearing loss and a feeling of aural fullness.
Based on supportive results from a Phase 2b trial, Otonomy is conducting two Phase 3 trials, AVERTS-1 in the United States and AVERTS-2 in Europe.
Results of both Phase 3 trials are expected in the second half of 2017. OTO-104 has been granted Fast Track designation for this indication by the FDA. Otonomy has also initiated a Phase 2 clinical trial for OTO-104 in a second indication, the prevention of hearing loss associated with cisplatin chemotherapy.