New Drug for Hearing Loss Enters Clinical Testing June 12th, 2006 – Seattle, WA Sound Pharmaceuticals initiates clinical testing of SPI-1005 for the prevention and treatment of noise induced hearing loss. Sound Pharmaceuticals has started a 32 patient Phase 1 study of SPI-1005 in normal healthy volunteers. SPI-1005 is an oral capsule, and contains as its active ingredient a selenium based small molecule mimic of the enzyme glutathione peroxidase. In multiple preclinical studies, low oral doses of SPI-1005 have been shown to be effective in preventing and treating noise induced hearing loss. “These animal studies have been replicated by three independent labs, all demonstrating that the active ingredient in SPI-1005 is effective in reducing both the temporary and permanent hearing loss associated with exposure to loud noise,” said VP and Director of Research, Eric Lynch, PhD. “This dose escalation safety study will lay the ground work for our Phase 2 safety and efficacy trials with the US Army and Navy later this year,” stated VP and Director of Clinical Operations, Bret MacPherson. The goal of the current study is to comfirm the known adsorption, distribution, metabolism, excretion and pharmacokinetic profile and to determine the safety of SPI-1005 at high doses. According to OSHA and the CDC, 30-40 million Americans are exposed to hazardous sound levels on a daily basis. Combined with a burgeoning population of war veterans and the dangerous listening habits of the MP3 generation, the societal costs for hearing devices and compensation awards have soared into the billions. There are currently no drugs for the prevention and treatment of hearing loss despite the vast and increasing need. Sound Pharmaceuticals hopes to address this need with its first in class first in indication drug, SPI-1005. 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. Website: http://soundpharmaceuticals.com/
SEATTLE, WA—Sound Pharmaceuticals, Inc. (SPI) announced that its patent “Stimulation of cellular differentiation and regeneration in the inner ear” has received a notice of allowance from the United States Patent and Trademark Office.
SPI is developing antisense oligonucleotides, RNAi duplexes, and expressed shRNA modalities to antagonize p27Kip1 at the mRNA level. Normally, p27Kip1 functions at the level of the nucleus by binding and thus inhibiting certain proliferation inducing Cyclin/CDK complexes.
Recent publications from researchers at both the House Ear Institute in Los Angeles (White et al., Nature 2006) and the Kresge Hearing Research Institute in Michigan (Kanzaki et al., Hearing Research 2006) continue to validate the importance of p27Kip1 in proliferative regeneration of the cochlea as previously described (Lowenheim et al., PNAS 1999).
“Sound Pharmaceuticals is developing a unique approach towards cellular regeneration in the cochlea by focusing on cell cycle control. This allows new cell production to occur locally with reduced potential for side effects” says Jonathan Kil, MD, President & CEO. This patent protected methodology will enter pre-clinical toxicology in the next year.
Sound Pharmaceuticals, is a drug development company focused on developing drugs to treat hearing loss and brain injury. For more information please visit http://www.soundpharmaceuticals.com
CONTACT: Dr. Jonathan Kil, President & CEO, Sound Pharmaceuticals, Inc., 4010 Stone Way N Suite 120, Seattle WA 98103, jkil@soundpharmaceuticals.com, 206-634-2559.
