FDA Allows Phase 2 Study for Sound Pharmaceuticals' Novel Drug to Prevent Chemotherapy Induced Hearing Loss

Aug 07, 2008, 01:00 ET from Sound Pharmaceuticals, Inc.

    SEATTLE, Aug. 7 /PRNewswire/ -- Sound Pharmaceuticals (SPI) has
 received FDA notification that it may proceed with its Phase II study to
 prevent chemotherapy induced hearing loss. The Ph-II study will enroll 80
 patients with advanced head and neck, and non-small cell lung cancer at the
 National Center for Rehabilitative Auditory Research at the Veterans
 Administration Hospital and the Oregon Health and Science University in
 Portland, Oregon.
     Hearing loss due to ototoxic medications such as chemotherapy,
 antibiotics or loop diuretics often results in permanent and progressive
 disability. Furthermore, the combined use of these ototoxic agents is
 contraindicated, often limiting their clinical utility. Symptoms of
 ototoxicity include hearing loss, tinnitus, dizziness, vertigo and
 difficulty understanding speech. Historically, the incidence of cisplatin
 or carboplatin-induced hearing loss was widely under estimated or reported
 due to inadequate testing or a lack of reporting. Recently, a new
 behavioral audiometric protocol has been developed and employed to test an
 individual's sensitive range for ototoxicity (SRO). This involves pure-tone
 audiometry at very specific steps within a person's upper range of hearing.
 With the SRO protocol, several studies now report an incidence of
 ototoxicity of 85-92% for cisplatin and carboplatin receiving cancer
 patients, an incidence that is much greater than previously reported. One
 of the goals of this Ph-II study is to reduce the incidence and severity of
 the ototoxicity in platinum receiving cancer patients as measured by
 pure-tone audiometry using the SRO protocol, distortion product otoacoustic
 emissions (DPOAEs) and the tinnitus handicap inventory. DPOAEs are a
 measure of outer hair cell function in the inner ear and are another
 sensitive and specific measure of ototoxicity.
     In several preclinical studies, SPI has showed that its novel
 chemoprotectant drug product, a small molecule that mimics and induces
 Glutathione Peroxidase activity was critical in preventing ototoxicity
 while not interfering with the chemotherapy treatment. In one rodent model
 of cancer, the chemoprotectant enhanced the tumoricidal activity of
     Sound Pharmaceuticals, Inc. is a privately held biopharmaceutical
 company with a focus on developing the first drugs for hearing loss and
 brain injury. For more information please contact Jonathan Kil, MD,
 President and CEO, 206-634-2559 or http://www.soundpharma.com.

SOURCE Sound Pharmaceuticals, Inc.