LA JOLLA, Calif., Oct. 20 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced it initiated dosing of the first cohort of subjects in a Phase I multiple dose clinical trial of NGX426, the oral prodrug of its most advanced product candidate, tezampanel. The trial is designed to evaluate the safety, tolerability and pharmacokinetics of NGX426 when given once daily for five consecutive days. NGX426 has been safely administered to more than 150 healthy adults in single doses from 10 to 210 mg. Data from the multiple dose trial will support the development of NGX426 in chronic pain indications such as neuropathic pain.
The double-blind, placebo-controlled, Phase I multiple dose trial is being conducted at a single center in the United States. A total of 20 healthy male and female adult volunteers will be enrolled in two sequential dose-escalating cohorts and will receive once daily oral doses of placebo, 90 mg or 150 mg of NGX426 for five consecutive days. These same dose strengths of NGX426 are currently being evaluated by TorreyPines in a Phase I single dose capsaicin induced hyperalgesia trial to evaluate the analgesic effect of NGX426. Results from this single dose trial are expected to be announced in December 2008.
"We are pleased with our development progress for NGX426. This novel, oral, non-opioid product candidate could potentially address significant unmet needs in treating migraine and other forms of chronic pain such as neuropathic pain," said Ev Graham, acting chief executive officer of TorreyPines Therapeutics. "The multiple dose trial, as well as the ongoing Phase I capsaicin trial evaluating the analgesic effect of NGX426, will guide us in planning our Phase II program."
Tezampanel and NGX426, are the first AMPA/kainate-type glutamate receptor antagonists to be studied in clinical trials. Glutamate receptors mediate the functioning of glutamate, an important excitatory neurotransmitter. While normal glutamate production is essential, excess glutamate production, either through injury or disease, can have a range of pathological effects. By acting at both the AMPA and kainate receptor site to competitively block the binding of glutamate, tezampanel and NGX426 have the potential to treat a number of diseases and disorders. These include migraine and other forms of chronic pain such as neuropathic pain, muscle spasticity, thrombosis, epilepsy and a condition known as central sensitization, a persistent state of hypersensitivity to pain that is a core component of many pain conditions.
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. 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, xerostomia and cognitive disorders. The company is currently developing three product candidates: two ionotropic glutamate receptor antagonists and one muscarinic receptor agonist. Further information 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, statements
regarding the potential for NGX426 as a treatment for neuropathic pain, the
potential for NGX426 to be analgesic, the anticipated timing of results for
the NGX426 study in a model of capsaicin-induced pain and the potential for
tezampanel and NGX426 as treatments for migraine and other indications,.
Such statements are subject to numerous known and unknown risks,
uncertainties and other factors, which may cause TorreyPines' actual
results to be materially different from historical results or from any
results expressed or implied by such forward-looking statements, 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 the company's 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 the company's product candidates
will be able to improve the signs or symptoms of their respective clinical
indication; whether any of the company's product candidates will support a
filing for marketing approval, will be approved by the regulatory
authorities, or if approved, will prove competitive in the market; or
whether the necessary financing to support the company's product
development programs will be available. In particular there is no guarantee
that clinical trials of any of the company's product candidates will be
completed on schedule or that results of these clinical trials will be
reported within the anticipated timeframe, that tezampanel or NGX426 will
successfully treat migraine, neuropathic pain and/or other indications for
which they are developed, or that TorreyPines will be able to complete the
necessary development work and receive regulatory approval for tezampanel
or. These and other risks which may cause results to differ are described
in greater detail in the "Risk Factors" section of TorreyPines' annual
report on Form 10-K for the year ended December 31, 2007 and TorreyPines
other SEC reports. The forward-looking statements are based on current
information that is likely to change and speak only as of the date hereof.
Company Contact: Investor Contact:
Paul Schneider Rhonda Chiger
TorreyPines Therapeutics, Inc. Rx Communications
858-623-5665, x158 917-322-2569
|SOURCE TorreyPines Therapeutics, Inc.|
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