LA JOLLA, Calif., Dec. 1 TorreyPines Therapeutics, Inc.(Nasdaq: TPTX) today announced that oral administration of NGX426, anAMPA/kainate-type glutamate receptor antagonist, demonstrated a statisticallysignificant reduction in spontaneous pain, hyperalgesia (abnormally increasedpain state) and allodynia (pain resulting from normally non-painful stimuli tothe skin) compared to placebo following intradermal injections of capsaicin ina human experimental model of cutaneous pain, hyperalgesia and allodynia.
"Human experimental models of pain are emerging as tools to predictefficacy of novel analgesics in early clinical trials," said principalinvestigator Mark Wallace, M.D., Professor of Clinical Anesthesiology andProgram Director, University of California San Diego Center for Pain Medicine."The results of NGX426 in this study are exciting and suggest that this drugwill be effective in clinical pain states. These study results should provideguidance in the development of Phase II clinical trials."
The single-center, in-clinic, randomized, double-blinded study enrolled atotal of 18 healthy male subjects. Using a three-period cross-over design,subjects received two intradermal injections of capsaicin at 30 minutes and120 minutes after administration of a single, oral dose of 90 mg or 150 mg ofNGX426, or placebo. Pain assessments were determined at specified intervalsafter each injection of capsaicin and measured by visual analog scale.
The 90 mg and 150 mg doses of NGX426 demonstrated analgesic effect on theprimary endpoints. The 150 mg dose was statistically significant compared toplacebo on all three measures: reduction in spontaneous pain, hyperalgesia andallodynia. The 90 mg dose also showed statistical significance on reduction ofhyperalgesia and allodynia and trended toward statistical significance onreduction in spontaneous pain. In addition, a statistically significantpain-reducing effect was observed for the 150 mg dose through 4.5 hourspost-dosing.
NGX426 was well tolerated and all subjects completed the three treatmentperiods. There were no serious or medically important adverse events orchanges on laboratory or ECG parameters. The most common adverse eventsassociated with NGX426 administration were mild somnolence and dizziness.
"We are very encouraged by these results that show an analgesic effect forNGX426 in this well-accepted pain model," said Ev Graham, Chief ExecutiveOfficer of TorreyPines. "As an oral, non-opioid pain agent, NGX426 couldaddress the significant and documented unmet needs in treating a range ofchronic pain conditions including neuropathic pain and acute or prophylactictreatment of migraine. These data, as well as data from our on-going Phase Imultiple dose trial, will help us structure our Phase II development plan forNGX426."
NGX426, an ester prodrug, is an oral form of tezampanel, TorreyPines mostadvanced product candidate. Pharmacokinetic analyses from two Phase I studiesconfirmed that when given to humans, NGX426 is rapidly converted totezampanel, the active moiety. Six Phase II, double-blind, placebo-controlledtrials have demonstrated that tezampanel, administered either subcutaneouslyor intravenously, was more effective than placebo in relieving pain acrossmigraine, nociceptive and neuropathic pain models, including acapsaicin-induced pain model.
In order to pursue the Phase II clinical development of NGX426 TorreyPinesintends to explore both strategic and financing initiatives.
About TorreyPines Therapeutics, Inc.
TorreyPines Therapeutics, Inc. 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, xerostomia and cognitive disorders.The company is currently developing three product candidates: two ionotropicglutamate receptor antagonists and one muscarinic receptor agonist. Furtherinformation is available at http://www.torreypinestherapeutics.com.
This press release contains forward-looking statements or predictions.Such forward-looking statements include, but are not limited to, statementsregarding the potential for NGX426 as a treatment for clinical pain states,including the potential for NGX426 as a treatment for neuropathic pain andacute migraine and for prevention of migraine, and the ability for TorreyPinesto successfully complete a strategic or financing transaction. Such statementsare subject to numerous known and unknown risks, uncertainties and otherfactors, which may cause TorreyPines' actual results to be materiallydifferent from historical results or from any results expressed or implied bysuch forward-looking statements, including whether experimental pain models ofpain, including the capsaicin model, are accurate in predicting efficacy ofnovel analgesics in early clinical trials, whether the results of any Phase IItrial or other study of NGX426 will be consistent with the results of thestudy reported in this press release, whether TorreyPines will be able tocomplete any potential strategic or financing transaction on terms acceptableto TorreyPines' stockholders, how the volatile economic environment willaffect TorreyPines' efforts to complete a strategic or financing transaction,whether TorreyPines' cash resources will be sufficient to fund operations asplanned, whether any preclinical studies or clinical trials, either ongoing orconducted in the future, will prove successful, and if successful, whether theresults can be replicated; whether safety and efficacy profiles of any of thecompany's product candidates will be established, or if established, willremain the same, be better or worse in future clinical trials, if any; whetherpre-clinical results will be substantiated by ongoing or future clinicaltrials, if any, or whether any of the company's product candidates will beable to improve the signs or symptoms of their respective clinical indication;whether any of the company's product candidates will support a filing formarketing approval, will be approved by the regulatory authorities, or ifapproved, will prove competitive in the market; or whether the necessaryfinancing to support the company's product development programs will beavailable. In particular there is no guarantee that clinical trials of any ofthe company's product candidates will be completed on schedule or that resultsof these clinical trials will be reported within the anticipated timeframe,that NGX426 will successfully treat migraine, neuropathic pain and/or otherindications for which it is developed, or that TorreyPines will be able tocomplete the necessary development work and receive regulatory approval forNGX426. These and other risks which may cause results to differ are describedin greater detail in the "Risk Factors" section of TorreyPines' annual reporton Form 10-K for the year ended December 31, 2007 and TorreyPines other SECreports. The forward-looking statements are based on current information thatis likely to change and speak only as of the date hereof.Company contact: Investor contact: Paul Schneider Rhonda Chiger TorreyPines Therapeutics, Inc. Rx Communications Group 858-623-5665 X125 (917) 322-2569 email@example.com firstname.lastname@example.org
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