Monday, 11 August 2008

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

�Sound Pharmaceuticals (SPI) has
received FDA notification that it may proceed with its Phase II study to
forestall chemotherapy induced hearing red ink. The Ph-II study testament enroll 80
patients with advanced question and cervix, 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 personnel casualty due to ototoxic medications such as chemotherapy,
antibiotics or loop diuretics oftentimes results in permanent and progressive
impairment. Furthermore, the combined exercise of these ototoxic agents is
contraindicated, often constraining their clinical utility. Symptoms of
ototoxicity include audience loss, tinnitus, dizziness, lightheadedness and
difficulty understanding address. Historically, the incidence of cisplatin
or carboplatin-induced audience loss was widely under estimated or reported
imputable to unequal testing or a lack of reportage. Recently, a new
behavioral audiometric protocol has been developed and employed to test an
individual's tender range for ototoxicity (SRO). This involves pure-tone
audiometry at selfsame specific steps within a person's upper range of hearing.
With the SRO protocol, several studies nowadays 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 rigourousness of
the ototoxicity in platinum receiving cancer patients as deliberate by
tone audiometry victimization the SRO protocol, distortion product otoacoustic
emissions (DPOAEs) and the tinnitus handicap inventory. DPOAEs are a
measure of outer hairsbreadth cell mathematical function in the inner ear and ar another
sensitive and specific measure of ototoxicity.



In several presymptomatic studies, SPI has showed that its novel
chemoprotectant drug mathematical product, a small molecule that mimics and induces
Glutathione Peroxidase activity was decisive in preventing ototoxicity
piece not busybodied with the chemotherapy intervention. In one rodent model
of cancer, the chemoprotectant enhanced the tumoricidal activity of
cisplatin.


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



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