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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. Approximately24 patients will be enrolled at three sites in the United States. In fourdistinct treatment periods, each patient will be randomized to receive asingle dose of 10 mg, 15 mg and 20 mg of NGX267 and placebo. The order oftreatment is determined by the Latin square design. The primary endpoint ofthe study is quantitative measure of salivary flow.
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"As we previously announced, we are focusing our clinical developmentactivities on maximizing the value of our lead compounds to take advantage oftheir versatility," said Neil Kurtz, M.D., President and Chief ExecutiveOfficer of TorreyPines Therapeutics. "Three Phase I studies have alreadydemonstrated the safety and tolerability of NGX267. More importantly forpatients suffering from xerostomia, two of these studies demonstratedstatistically significant increases in salivary flow. We are well-positionedto advance NGX267 as a potential new treatment for xerostomia associated withSjogren's syndrome."
In a Phase I multiple-dose study completed in September 2007, salivaryflow increased linearly with doses of NGX267, and these increases weremaintained over four days of dosing.
"Xerostomia is a hallmark symptom of Sjogren's syndrome, one of the mostprevalent autoimmune disorders, striking as many as 4 million Americans," saidSteven Taylor, Chief Executive Officer of the Sjogren's Syndrome Foundation."While there are treatments available for xerostomia, there is still asignificant need for new therapies that could offer patients less frequentdosing regimens and better tolerability."
About Xerostomia
Xerostomia, or dry mouth, is the result of decreased salivary flow and isa symptom of a number of underlying conditions. Causes of dry mouth includeSjogren's syndrome; radiation treatment to the head and neck; and HIV-relatedsalivary gland disease. Xerostomia can also be a side effect of medicationsand is associated with aging.
About TorreyPines Therapeutics
TorreyPines Therapeutics is a biopharmaceutical company committed toproviding patients with better alternatives to existing therapies through theresearch, development and commercialization of small molecule compounds. Thecompany's goal is to develop versatile product candidates each capable oftreating a number of acute and chronic diseases and disorders such asmigraine, chronic pain, muscle spasticity and rigidity, xerostomia andcognitive disorders. The company is currently developing four productcandidates, two ionotropic glutamate receptor antagonists and two muscarinicreceptor agonists. Further information is available athttp://www.torreypinestherapeutics.com.
This press release contains forward-looking statements or predictions,including statements regarding the company's strategic plan for 2008, theversatility of the company's product candidates, the potential of NGX267 as atreatment for xerostomia and the potential timing and scope of clinical trialsof NGX267. Such statements are subject to numerous risks, and uncertaintiesthat may cause actual events or results to differ materially from thecompany's current expectations. Statements regarding TorreyPines Therapeutics'product candidates are subject to risks and uncertainties regardingdevelopment, regulatory approval and commercialization, including whether theresults of completed trials of NGX267 are predictive of results in subsequenttrials of such product candidates; whether further testing of NGX267 willresult in data s
