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 cisplatin.
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.
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