Navigation Links
Otonomy's OTO-104 Demonstrates Hearing Loss Protection and Hearing Recovery in Preclinical Studies

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.  Pre-treatment with OTO-104 was also shown to provide nearly complete protection against hearing loss induced by cisplatin, a standard anti-cancer drug.  In each of these studies, hearing loss was evaluated using auditory brainstem response (ABR) which is a quantifiable measure of hearing function.

OTO-104 is a sustained release dexamethasone gel designed for direct injection into the middle ear as a potential treatment for hearing loss and balance disorders.  Otonomy's proprietary formulation is intended to overcome the limitations associated with short acting solutions which include the need for multiple IT injections and large variability of delivered dose.  In addition to its work in the area of hearing loss, the company is also currently conducting a prospective, randomized, placebo-controlled, multicenter, Phase 1b study of OTO-104 given as a single IT injection for the treatment of unilateral Meniere's disease.  While the primary endpoint of the study is safety and tolerability, a number of additional endpoints are being monitored, including the frequency of vertigo attacks experienced by patients pre- and post-treatment.  

According to the National Institute on Deafness and Other Communication Disorders (NIDCD), approximately 17 percent (36 million) of American adults report some degree of hearing loss.  Furthermore, the NIDCD estimates that approximately 15 percent (26 million) of Americans between the ages of 20 and 69 have high frequency hearing loss due to noise exposure at work or during leisure activities.  In addition, there are more than 1 million cancer patients, including children, treated each year with chemotherapeutic agents known to cause irreversible hearing loss according to the United Kingdom's Royal National Institute for Deaf People (RNID).

About OtonomyOtonomy is a clinical stage biopharmaceutical company developing novel drug therapies for diseases and disorders of the inner and middle ear.  The company's core technology is a sustained release formulation developed for optimal delivery of drugs from a single intratympanic (IT) injection. Broad applicability of this delivery and formulation technology has been established across a range of therapeutic classes and two products based on this platform are in active development.  Otonomy's lead product candidate, OTO-104, is a sustained release formulation of the steroid dexamethasone.  A Phase 1b clinical trial is ongoing in Meniere's disease patients, and future studies are being planned for acute onset hearing loss.  OTO-201, the company's second product candidate, is a novel sustained release antibiotic being developed for the treatment of chronic otitis media.  OTO-201 clinical trials are expected to begin in 2011.  Additional product candidates are expected to target acute and chronic forms of hearing loss, balance disorders, and tinnitus.

For more information visit: Communication (On behalf of Otonomy)Stephanie Diaz (investors)

Tim Brons (media)415-675-7400

SOURCE Otonomy, Inc
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. SAFC Hitech(TM) Successfully Demonstrates Device-Quality GST Precursors For Phase Change Memory Applications
2. SuperGens MP-470 Demonstrates Clinical Tumor Regression When Combined with Standard of Care Chemotherapy
3. EntreMeds ENMD-2076 Demonstrates Tumor Regression in Human Colon Cancer Model
4. Vaxart Demonstrates Efficacy of Oral Avian Flu Vaccine in Preclinical Studies
5. Study From the University of Texas M.D. Anderson Cancer Center Demonstrates That AHCC(R) is Safe in Combination With Most Chemotherapeutic Agents
6. RVX-208 Data Demonstrates Increase in Functional HDL Particles
7. Antheras Varespladib Demonstrates Significant Anti-Inflammatory Effect and LDL Reduction in Patients With Coronary Heart Disease
8. Human clinical study demonstrates superior Neptune Krill Oil NKO(R) pharmacokinetic profile
9. Sparta Systems Demonstrates Global Enterprise Quality Management Leadership at TrackWise(R) Connection User Conferences
10. Epilepsia Study Demonstrates New Add-on Antiepileptic Drug Vimpat(R) (lacosamide) Significantly Reduces Partial-Onset Seizures in Adults With Epilepsy
11. First Multiple Dose Clinical Trial of TorreyPines Therapeutics Oral Compound NGX426 Demonstrates Compound Is Safe and Well-Tolerated
Post Your Comments:
(Date:11/24/2015)... Inc., a worldwide provider of clinical research services headquartered in ... has set a new quarterly earnings record in Q3 of 2015.  ... Q3 of 2014 to Q3 of 2015.   ... the establishment of an Asia-Pacific office to ... and Mexico , with the establishment ...
(Date:11/24/2015)... Massachusetts , November 24, 2015 SHPG ... will participate in the Piper Jaffray 27 th Annual Healthcare ... Tuesday, December 1, 2015, at 8:30 a.m. EST (1:30 p.m. GMT). ... , Chief Financial Officer, will participate in the Piper Jaffray 27 ... , NY on Tuesday, December 1, 2015, at 8:30 a.m. ...
(Date:11/24/2015)... , Nov. 24, 2015  Twist Bioscience, ... that Emily Leproust, Ph.D., Twist Bioscience chief executive ... Healthcare Conference on December 1, 2015 at 3:10 ... in New York City. --> ... . Twist Bioscience is on Twitter. Sign ...
(Date:11/24/2015)... , Nov. 24, 2015 /CNW Telbec/ - ProMetic Life Sciences ... today that Mr. Pierre Laurin , President and Chief ... at the upcoming Piper Jaffray 27 th Annual Healthcare ... on December 1-2, 2015. st , at ... one-on-one meetings throughout the day. The presentation will be available ...
Breaking Biology Technology:
(Date:11/12/2015)... 11, 2015   Growing need for low-cost, ... has been paving the way for use of ... discrete analytes in clinical, agricultural, environmental, food and ... used in medical applications, however, their adoption is ... to continuous emphasis on improving product quality and ...
(Date:11/10/2015)... Nov. 10, 2015 About ... that helps to identify and verify the identity ... considered as the secure and accurate method of ... a particular individual because each individual,s signature is ... especially when dynamic signature of an individual is ...
(Date:11/4/2015)... --> --> ... Transparency Market Research "Home Security Solutions Market - Global Industry ... 2022", the global home security solutions market is expected to reach ... market is estimated to expand at a CAGR of ... Rising security needs among customers at homes, the emergence ...
Breaking Biology News(10 mins):