San Diego, CA (GLOBE NEWSWIRE) - Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today 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 CEO 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. Additional information about the clinical trial can be found at www.clinicaltrials.gov.
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 agents1. 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.
1Landier et al., Journal of Clinical Oncology, 2014.
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.
Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery in pediatric patients, and has achieved positive pivotal trial results in patients with acute otitis externa. OTO-104 is a steroid in development for the treatment of Ménière's disease and other severe balance and hearing disorders. Two Phase 3 trials in Ménière's disease patients are underway with results expected during the second half of 2017, and a Phase 2 trial has been initiated in patients at risk for cisplatin-induced hearing loss. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. Otonomy’s proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. For additional information please visit www.otonomy.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, the number of patients expected to participate in the Phase 2 clinical trial for OTO-104 in cisplatin-induced hearing loss, and the timing of results for the two OTO-104 Phase 3 clinical trials in Ménière's disease. Otonomy's expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to obtain additional financing; Otonomy's dependence on the commercial success of OTIPRIO and the regulatory success and advancement of additional product candidates, such as OTO-104 and OTO-311, and label expansion indications for OTIPRIO; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the preclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy's product candidates; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct preclinical studies and clinical trials; the timing and outcome of hospital pharmacy and therapeutics reviews and other facility reviews; the impact of coverage and reimbursement decisions by third-party payors on the pricing and market acceptance of OTIPRIO; Otonomy's dependence on third parties for the manufacture of OTIPRIO and product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to OTIPRIO and its product candidates in the United States and throughout the world; expectations regarding potential market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 3, 2016, and Otonomy's future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.
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