TorreyPines
Therapeutics, Inc. (Nasdaq: TPTX) announced that it has initiated a
Phase I multiple dose clinical trial to evaluate the safety, tolerability
and pharmacokinetics of tezampanel given as a subcutaneous injection to
healthy male and female volunteers once-daily for four consecutive days.
Tezampanel, an AMPA/kainate (AK) receptor antagonist that selectively binds
to certain AK receptors to potentially block the transmission of pain
signals, has been administered in single doses to more than 300 patients
and healthy adults. Data from this multiple dose trial will support the
continued development of tezampanel for the treatment of migraine as well
as allow TorreyPines to consider expanding the development of tezampanel
into additional chronic pain conditions.
The double-blind, placebo-controlled, multiple-dose trial will be
conducted at one center in the United States. Approximately 30 healthy male
and female volunteers, between the ages of 21 and 55, will be enrolled in
sequential, dose-escalating cohorts and receive once-daily subcutaneous
doses of placebo or 40 mg, 70 mg or 100 mg of tezampanel for four
consecutive days. These same dose strengths, given as a single dose
subcutaneous injection, are currently being evaluated by TorreyPines in a
Phase IIb clinical trial of tezampanel for acute migraine.
"We are pleased with our development progress for tezampanel," said
Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines.
"Our Phase IIb trial in migraine has completed enrollment and we are on
track to announce top line results in the fourth quarter of this year. We
believe tezampanel represents a potentially new and promising alternative
to current treatments for not only migraine but also other pain conditions.
Obtaining multiple dose safety and tolerability data will allow us to plan
future studies in those chronic painful conditions."
In five Phase IIa, placebo-controlled trials, tezampanel demonstrated
proof of concept in multiple pain models. In a placebo and
active-controlled clinical trial in patients with acute migraine, the
compound, administered intravenously, achieved statistical significance on
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
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 block opioid receptors or constrict blood
vessels, the safety profile of AK antagonists may offer important
advantages over existing drugs to treat migraine and other pain conditions.
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 torreypinestherapeutics.
This press release contains forward-looking statements or predictions.
Such forward-looking statements include, but are not limited to, statements
regarding the anticipated timing for reporting clinical trial results for
tezampanel, the potential for tezampanel as a treatment for migraine and
other pain indications and the potential of TorreyPines Therapeutics'
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.
torreypinestherapeutics