Sound Pharmaceuticals Announces The Successful Completion Of Its Phase I Clinical Trial For SPI-1005

January 6, 2007 – 7:46 pm | posted in Clinical Trials / Drug Trials, Hearing / Deafness

Sound Pharmaceuticals (SPI) has completed Phase I clinical testing of SPI-1005, an oral compound, under development for the prevention and treatment of noise induced hearing loss. Results from this 32 patient study and the protocol of an upcoming Phase II clinical study in 80 noise-exposed volunteers will be presented at the 30th Association for Research in Otolaryngology Midwinter Meeting in Denver, CO on Feb. 10-15. SPI has established a Cooperative Research Development Agreement with the Naval Medical Research Center to conduct this Phase II study at Camp Pendleton, CA.

“We are very pleased with the outcome of our first clinical study,” said Bret MacPherson, VP and Director of Clinical Operations. “This marks a major milestone for SPI as it transitioned its first product pipeline into clinical development.” SPI is developing three product pipelines for indications in noise induced, chemotherapy induced and age-related hearing loss. In addition, SPI intends to apply these drug candidates to other neurodegenerative diseases including traumatic brain injury.

According to two recent studies conducted by Clarity and The Ear Foundation in 2004 and 2006, half of the nearly 76 million Baby Boomers in the U.S. are experiencing some degree of hearing loss. These findings suggest that hearing loss has become the leading chronic disease or disorder in adults aged 41-60. Currently there are no FDA approved drugs for the prevention and treatment of hearing loss. SPI hopes to address this unmet medical need with its first-in-class first-in-indication drug.

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