TorreyPines
Therapeutics, Inc. (Nasdaq: TPTX) today announced that it has initiated a
second Phase I clinical trial of NGX426, a novel product candidate intended
to treat chronic pain conditions such as migraine and neuropathic pain.
NGX426 is an oral prodrug of tezampanel, the company's parenteral product
candidate currently in a Phase IIb clinical trial for acute migraine.
The double-blind, placebo-controlled, clinical trial will evaluate the
safety, tolerability and pharmacokinetics of NGX426 to determine the
maximum safe and well-tolerated oral dose. Approximately 60 healthy adult
volunteers, enrolled in sequential, dose-escalating cohorts, will receive
placebo or a single dose of NGX426. The trial is intended to evaluate doses
of NGX426 ranging from 40 mg up to the maximum tolerated dose. In a
previous Phase I trial, completed in November 2006, NGX426 was well
tolerated at doses up to 30 mg and pharmacokinetic analyses confirmed that
it was rapidly converted to tezampanel.
"This second Phase I trial for NGX426 is an important next step in
establishing the safety and tolerability of this potential new treatment
for chronic pain conditions such as migraine," said Neil Kurtz, M.D.,
President and Chief Executive Officer of TorreyPines. "As an oral prodrug
of tezampanel, NGX426 broadens our portfolio by providing an additional
route of administration to potentially address the varied and unmet needs
of pain sufferers. We look forward to moving ahead with our clinical
program."
Tezampanel and NGX426 are AMPA/kainate (AK) receptor antagonists that
potentially offer a non-narcotic, non-vascular approach to the treatment of
chronic pain, including migraine. AK receptor antagonists selectively block
transmission of pain signals mediated through the activation of glutamate
receptors. These receptors play a critical role in the development of
central sensitization phenomena -- a key component of many chronic pain
conditions, including migraine and neuropathic pain. As AK receptor
antagonists, tezampanel and NGX426 may effectively relieve severe and
persistent pain through a novel mechanism of action without imparting the
side effects and risks associated with currently available treatment
options for chronic pain, including migraine. Five Phase IIa, double-blind,
placebo-controlled trials have demonstrated that tezampanel, administered
intravenously, was more effective than placebo in relieving pain symptoms
across multiple pain models, including migraine.
About TorreyPines Therapeutics, Inc.
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
cognitive impairment associated with schizophrenia and Alzheimer's disease.
TorreyPines' common stock is traded on the NASDAQ Global Stock Market under
the symbol "TPTX." For detailed company information, including copies of
this and other press releases, please visit TorreyPines' website at
torreypinestherapeutics/.
This press release contains forward-looking statements or predictions.
Such forward-looking statements include, but are not limited to, statements
regarding the potential of NGX426 and tezampanel to treat chronic pain,
including migraine and neuropathic pain and the potential for NGX426 and
tezampanel to have reduced side-effects and risks compared to currently
available treatment option. 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. In particular there is no guarantee that NGX426 or tezampanel
will be safe and efficacious, that NGX426 or tezampanel will actually treat
chronic pain or that TorreyPines will be able to complete the necessary
development work and receive regulatory approval for NGX426 or tezampanel.
These and other risks which may cause results to differ are described in
greater detail in the registration statement on Form S-4, as amended, as
filed with the Securities and Exchange Commission and the "Risk Factors"
section of TorreyPines' Form 10-Q for the quarter ended September 30, 2006
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.
TorreyPines Therapeutics, Inc.
torreypinestherapeutics/