FDA Allows Phase 2 Study For Sound Pharmaceuticals' Novel Drug To Prevent Chemotherapy Induced Hearing Loss

Main Category: Hearing / Deafness
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 09 Aug 2008 - 0:00 PST

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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 cisplatin.

Sound Pharmaceuticals, Inc.
http://www.soundpharma.com