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Otonomy's OTO-104 Demonstrates Hearing Loss Protection and Hearing Recovery in Preclinical Studies
Date:2/22/2011

SAN DIEGO, Feb. 22, 2011 /PRNewswire/ -- Otonomy, Inc., a developer of innovative therapeutics for diseases and disorders of the ear, today announced positive results for the company's lead product candidate, OTO-104, in multiple preclinical models of hearing loss.  Data demonstrated that a single intratympanic (IT) injection of OTO-104, a sustained release gel formulation of the corticosteroid dexamethasone, provided significant protection against both noise-induced and chemotherapy-induced hearing loss when administered prior to trauma.  The treatment was also shown to promote recovery from noise-induced hearing loss when administered several days following trauma.  These findings were presented at this week's 34th MidWinter Meeting of the Association for Research in Otolaryngology (ARO).

"The most compelling aspect of these findings is the breadth of therapeutic effect that we were able to demonstrate.  The fact that a single injection of OTO-104 was protective against both noise-induced and chemotherapy-induced hearing loss, when dosed either before or after trauma is an impressive result," stated Carl LeBel, Ph.D., chief scientific officer of Otonomy.  "Most importantly, these results lend support to the potential utility of OTO-104 in protecting cancer patients from a damaging side effect of chemotherapy, and hold the promise for treating individuals exposed to excessive noise on the battlefield or in the workplace. We look forward to advancing OTO-104 into clinical trials for these patients."

Researchers administered one of three OTO-104 doses or an inactive control via a single IT injection and measured therapeutic activity in the preclinical hearing loss models.  Data demonstrated a significant reduction in hearing loss with higher doses of OTO-104 administered prior to noise exposure, and a significant increase in the level of hearing recovery when administered up to two days after the acoustic trauma.  
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