Sound Pharmaceuticals Wins FDA Approval for Phase II Hearing Loss Study
Posted on: Friday, 8 August 2008, 12:00 CDT
Sound Pharmaceuticals has received the FDA notification that it may proceed with its Phase II study to prevent chemotherapy induced hearing loss.
The Phase 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.
One of the goals of this Phase 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 sensitive range for ototoxicity protocol, distortion product otoacoustic emissions and the tinnitus handicap inventory.
In several preclinical studies, Sound Pharmaceuticals has showed that its 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.
Source: Datamonitor
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