TorreyPines Therapeutics Completes Patient Enrollment In Phase IIb Clinical Trial Of Tezampanel For The Treatment Of Acute Migraine Headache

Main Category: Headache / Migraine
Also Included In: Clinical Trials / Drug Trials
Article Date: 07 Aug 2007 - 0:00 PDT

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TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that it has completed enrollment in its Phase IIb clinical trial of tezampanel for the treatment of acute migraine headache. Tezampanel is an AMPA/kainate (AK) receptor antagonist that offers a non-opioid, non-vascular and non-serotonergic approach to the management of pain and represents a potentially new and promising alternative to current migraine treatments.

The clinical trial is a double-blind, placebo-controlled, multi-center trial that reached its targeted enrollment of 300 patients suffering a single migraine attack, with or without aura. Patients are randomized to one of four arms and receive a 40 mg, 70 mg, or 100 mg single, subcutaneous dose of tezampanel or placebo. The purpose of the trial is to identify a dose, or a range of doses, that could be used in a Phase III development program for tezampanel in acute migraine. The primary efficacy endpoint for the trial is headache pain relief at two hours post-dose. Secondary efficacy endpoints include pain free status at two hours, sustained pain relief and sustained pain free at 24 hours, and headache recurrence and relapse. Additional measures include assessments of functional disability and patient satisfaction, relief of migraine-associated symptoms such as nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound), as well as various assessments that characterize speed of treatment onset. Safety, tolerability and plasma pharmacokinetic data will also be evaluated.

"Completing enrollment in our Phase IIb trial with tezampanel is an important milestone for us," said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines. "We believe tezampanel has the potential to offer migraine patients an important new treatment option with a novel mechanism of action and we remain on track to announce top line results from the study during the fourth quarter of this year."

In previous clinical trials, tezampanel has been administered to more than 200 healthy adult volunteers or patients. In five Phase IIa, placebo-controlled trials using intravenous administration, tezampanel demonstrated proof of concept in multiple pain models. In one placebo and active-controlled clinical trial in patients with acute migraine, the compound achieved statistical significance in all primary and secondary endpoints traditionally required for regulatory approval. These endpoints included pain relief at two hours, pain-free at two hours and relief of nausea, photophobia and phonophobia.

About AK Receptor Antagonists

AMPA/kainate (AK) receptors are part of the glutamate biological pathway that transmits pain signals to the brain. In addition, these receptors play a critical role in the development of central sensitization phenomena -- a key component of many pain syndromes, including migraine and persistent pain states such as chronic neuropathic pain. AK receptor antagonists selectively bind to certain AK receptors to block transmission of pain signals mediated through the activation of a subtype of glutamate receptors. Because they do not bind to opioid receptors, directly bind to serotonin receptors or constrict blood vessels, the safety profile of AK antagonists may offer important advantages over existing drugs to treat migraine and other chronic pain conditions.

About Migraine

Migraine is a painful neurological condition characterized by an intense and disabling episodic headache. According to the National Headache Foundation, an estimated 30 million people in the U.S. suffer from migraines. In addition to headache pain, migraine attacks are frequently accompanied by photophobia, phonophobia, nausea, and vomiting. Although once thought to be primarily caused by vascular changes in the brain, some researchers now consider migraine a neurological disorder.

About TorreyPines Therapeutics

TorreyPines Therapeutics, Inc. is a clinical stage biopharmaceutical company that discovers and develops small molecule drugs 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 Alzheimer's disease and cognitive impairment associated with schizophrenia. Further information is available at http://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 and other pain indications and the potential of the company's product candidates to treat certain diseases and disorders. Such statements are subject to numerous factors, risks, and uncertainties that may cause actual events or results to differ materially from the combined company's current expectations. Statements regarding TorreyPines Therapeutics' product candidates are subject to risks and uncertainties regarding development, regulatory approval and commercialization, including 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 December 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