LA JOLLA, Calif., March 18 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced it has initiated a Phase II study of NGX267, a muscarinic agonist in development for xerostomia, or dry mouth, secondary to Sjogren's syndrome.
The company is conducting a randomized, double-blind, placebo-controlled, cross-over study with a Latin square design to evaluate the safety, tolerability and efficacy of this once-a-day compound. Approximately 24 patients will be enrolled at three sites in the United States. In four distinct treatment periods, each patient will be randomized to receive a single dose of 10 mg, 15 mg and 20 mg of NGX267 and placebo. The order of treatment is determined by the Latin square design. The primary endpoint of the study is quantitative measure of salivary flow.
"As we previously announced, we are focusing our clinical development activities on maximizing the value of our lead compounds to take advantage of their versatility," said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines Therapeutics. "Three Phase I studies have already demonstrated the safety and tolerability of NGX267. More importantly for patients suffering from xerostomia, two of these studies demonstrated statistically significant increases in salivary flow. We are well-positioned to advance NGX267 as a potential new treatment for xerostomia associated with Sjogren's syndrome."
In a Phase I multiple-dose study completed in September 2007, salivary flow increased linearly with doses of NGX267, and these increases were maintained over four days of dosing.
"Xerostomia is a hallmark symptom of Sjogren's syndrome, one of the
most prevalent autoimmune disorders, striking as many as 4 million
|SOURCE TorreyPines Therapeutics, Inc.|
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