TorreyPines Therapeutics Initiates Phase II Study Of Muscarinic Agonist NGX267 For Treatment Of Xerostomia

Main Category: Endocrinology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 19 Mar 2008 - 0:00 PDT

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TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) 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 Americans," said Steven Taylor, Chief Executive Officer of the Sjogren's Syndrome Foundation. "While there are treatments available for xerostomia, there is still a significant need for new therapies that could offer patients less frequent dosing regimens and better tolerability."

About Xerostomia

Xerostomia, or dry mouth, is the result of decreased salivary flow and is a symptom of a number of underlying conditions. Causes of dry mouth include Sjogren's syndrome; radiation treatment to the head and neck; and HIV-related salivary gland disease. Xerostomia can also be a side effect of medications and is associated with aging.

About TorreyPines Therapeutics

TorreyPines Therapeutics is a biopharmaceutical company committed to providing patients with better alternatives to existing therapies through the research, development and commercialization of small molecule compounds. The company's goal is to develop versatile product candidates each capable of treating a number of acute and chronic diseases and disorders such as migraine, chronic pain, muscle spasticity and rigidity, xerostomia and cognitive disorders. The company is currently developing four product candidates, two ionotropic glutamate receptor antagonists and two muscarinic receptor agonists. Further information is available at http://www.torreypinestherapeutics.com.

This press release contains forward-looking statements or predictions, including statements regarding the company's strategic plan for 2008, the versatility of the company's product candidates, the potential of NGX267 as a treatment for xerostomia and the potential timing and scope of clinical trials of NGX267. Such statements are subject to numerous risks, and uncertainties that may cause actual events or results to differ materially from the company's current expectations. Statements regarding TorreyPines Therapeutics' product candidates are subject to risks and uncertainties regarding development, regulatory approval and commercialization, including whether the results of completed trials of NGX267 are predictive of results in subsequent trials of such product candidates; whether further testing of NGX267 will result in data sufficient to support regulatory approval; whether the company will be able to develop and obtain regulatory approval of its product candidates for treatment of multiple diseases and disorders; whether any preclinical studies or clinical trials, either ongoing or conducted in the future, will prove successful, and if successful, whether the results can be replicated; whether safety and efficacy profiles of any of its product candidates will be established, or if established, will remain the same, be better or worse in future clinical trials, if any; whether pre-clinical results will be substantiated by ongoing or future clinical trials, if any, or whether any of its product candidates will be able to improve the signs or symptoms of their respective clinical indication; whether any of its product candidates will support a filing for marketing approval, will be approved by applicable regulatory authorities, or if approved, will prove competitive in the market; and whether the necessary financing to support its product development programs will be available. Actual results may differ materially from the above forward-looking statements due to a number of other important factors. These and other risks which may impact management's expectations are described in greater detail in the TorreyPines Therapeutics annual report on Form 10-K for the year ended Dec. 31, 2006, as well as TorreyPines Therapeutics' subsequent filings with the Securities and Exchange Commission. TorreyPines Therapeutics undertakes no obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

TorreyPines Therapeutics, Inc.
http://www.torreypinestherapeutics.com

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