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DESCRIPTION (provided by applicant): Sensorineural hearing loss is a major medical problem with over 32 million Americans affected. The most common form is presbycusis or aging hearing loss. Other types of hearing loss include noise exposure, genetic losses, viral and bacterial infections, ototoxic medications, autoimmune, and idiopathic. The understanding of the molecular biology responsible for hearing loss is continuing to evolve. However, the pathophysiology of many common clinical conditions is still not completely understood. There is no FDA-approved pharmacological agent for treatment of sensorineural hearing loss. This Phase I SBIR proposal involves the fabrication of therapeutic treatments for sensorineural hearing loss, with a specific focus on autoimmune inner ear disease. The specific aims of this proposal present a roadmap towards the early stage development of biologic agent formulations for the round window administered treatment of autoimmune inner ear disease. The aims of this proposal are threefold: First, the development of prototype extended release composition of the therapeutic formulation to incorporate the desired therapeutic dose and release duration. Second, the activity of the release therapeutic will be analyzed utilizing cell culture analyses. Third, extended release implant formulations will be tested in animal models for safety and drug distribution in the middle and inner ear. This will yield prototype implants that will release actie therapeutic over the desired four week period. The team of investigators at O-Ray is uniquely qualified to perform the work proposed herein, and has expertise in otology, drug development and drug delivery for the successful development this product. O-Ray scientists have successfully developed therapeutic formulations that are currently being used in the clinic. This includes an intraocular sustained release steroid implant capable of maintaining anti-inflammatory intravitreal drug levels for periods of up to 3 years from a single implantation. Phase II of this project will involve completion of a final extended release infliximab formulation
for a scale up in manufacture, the testing of stability and sterility of these formulations, and safety and pharmacokinetic animal studies sufficient to lead to an Investigational New Drug Exemption. The completion of this work will ultimately facilitate a collaboration with a corporate partner for the licensing of our developed product.
