LA JOLLA, Calif., Dec. 10 /PRNewswire/ -- TorreyPines Therapeutics, Inc. today reported pharmacokinetic data obtained in a Phase I maximum tolerated dose clinical trial of NGX426, the oral prodrug of tezampanel, show that the area under the curve (AUC), which represents the total amount of drug absorbed by the body, of a single, 80 mg, oral dose of NGX426 is comparable to the AUC of a single, 40 mg, subcutaneous dose of tezampanel.
With the recently demonstrated efficacy of 40 mg of tezampanel in a Phase IIb clinical trial in acute migraine, the comparable AUCs suggest that NGX426 also may be effective in treating acute migraine headache. TorreyPines Therapeutics plans to initiate a Phase IIa study of NGX426 in acute migraine in the first half of 2008.
"These findings with the oral form of tezampanel are very encouraging, especially when looked at in conjunction with the data from our evaluation of the subcutaneous form," said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines Therapeutics. "These data fully support the continued development of NGX426, which, as an oral prodrug, can provide an additional route of administration for tezampanel to acute migraine sufferers."
Initiated earlier this year, this double-blind, placebo-controlled trial enrolled normal healthy adult volunteers in sequential, dose-escalating cohorts. The Phase I data show that single, oral doses of NGX426 from 40 mg to 90 mg are safe and well-tolerated. TorreyPines Therapeutics is amending the Phase I clinical trial protocol to extend the dosing range beyond 90 mg to identify the maximum tolerated dose.
Tezampanel is the first AMPA/kainate antagonist to be studied in a clinical trial for acute migraine. Both tezampanel and the oral prodrug NGX426 represent a novel, non-opiod, non-vascular and non-serotonergic approach to treating multiple pain conditions, including migraine. Tezampanel and NGX426 are antagonists of a subgroup of glutamate receptors referred to as AMPA and kainate. These receptors are found in areas of the central and peripheral nervous system that are important for the transmission of pain. During a migraine attack, levels of glutamate increase and activate these receptors, facilitating the transmission of pain impulses. Tezampanel, by blocking the binding of glutamate to these receptors, is believed to inhibit the transmission of pain signals that lead to migraine headaches.
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. is a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel small molecules to treat diseases and disorders of the central nervous system (CNS). Led by an accomplished management team, TorreyPines is leveraging novel drug targets and technologies to potentially deliver new CNS therapies for chronic pain, including migraine and neuropathic pain; and cognitive disorders, including cognitive impairment associated with schizophrenia and Alzheimer's disease. Further information is available at www.torreypinestherapeutics.com.
This press release contains forward-looking statements or predictions. Such forward-looking statements include statements regarding the potential for tezampanel as a treatment for migraine, the potential for NGX426 as a treatment for migraine, the potential for tezampanel to offer a unique approach to the management of pain, the potential for NGX426 to offer a unique approach to the management of pain and the potential timing, development and initiation of Phase II clinical trials of NGX426. 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 the Phase IIb trial are predictive of results in subsequent trials of tezampanel, whether the results of the Phase I trial are predictive of results in subsequent trials of NGX426, whether the areas under the curve for tezampanel and NGX426 are meaningful indicators of the efficacy of NGX426, whether further testing of tezampanel and NGX426 will result in data sufficient to support regulatory approval, whether AMPA/kainate antagonists will prove to be safe and effective treatments for migraine and other pain conditions, 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 drug 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 drug candidates will be able to improve the signs or symptoms of their respective clinical indication; whether any of its drug candidates will support an NDA filing, will be approved by the FDA or its equivalent, or if approved, will prove competitive in the market; or whether the necessary financing to support its drug 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.
egraham@torreypinestherapeutics.com david.schull@russopartnersllc.comrchiger@rxir.com
CONTACT: Ev Graham of TorreyPines Therapeutics, Inc., +1-858-623-5665,
Ext. 118, egraham@torreypinestherapeutics.com; Media, David Schull of Russo
Partners, LLC, +1-212-845-4271, david.schull@russopartnersllc.com;
Investors, Rhonda Chiger of Rx Communications, +1-917-322-2569,
rchiger@rxir.com; or John Baldissera, of BPC Financial Marketing,
+1-800-368-1217, all for TorreyPines Therapeutics, Inc.
Web site: http://www.torreypinestherapeutics.com/
