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TorreyPines Therapeutics Muscarinic Agonist NGX267 Meets Primary Endpoint in a Phase II Clinical Trial in Patients with Xerostomia
Date:12/2/2008

LA JOLLA, Calif., Dec. 2 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced positive results from a 26 patient Phase II trial evaluating three doses of NGX267 as a treatment for xerostomia, or dry mouth, in patients with Sjogren's syndrome. NGX267 met the primary endpoint of a statistically significant increase in salivary flow production compared to placebo at all three doses: 10 mg, 15 mg, and 20 mg. These doses were safe and well tolerated with few reports of excessive sweating and gastrointestinal complaints.

"The preliminary data look very impressive and offer new hope to patients with Sjogren's syndrome," said principal investigator Frederick B. Vivino, M.D., Chief, Division of Rheumatology, Penn Presbyterian Medical Center, Clinical Associate Professor of Medicine, University of Pennsylvania School of Medicine and Director of the Penn Sjogren's Syndrome Center. "NGX267 appears to be efficacious, safe and well tolerated in short term use. The results of this recently completed clinical trial undoubtedly justify the design and execution of longer placebo-controlled trials in a larger group of Sjogren's syndrome patients. This will help us better elucidate the full benefit of this novel treatment."

"The findings from this study are very promising given the demonstrated efficacy and low incidence of adverse events for the three doses of NGX267," said Ev Graham, Chief Executive Officer of TorreyPines. "Moving forward, we now have data that suggests this well-tolerated product candidate could be effective in treating dry mouth associated with Sjogren's syndrome, and possibly other conditions in which a reduction in salivary flow has been observed such as the effects of head and neck radiation, diabetes and aging. According to our preliminary market research, there is a significant need f
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SOURCE TorreyPines Therapeutics, Inc.
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