TorreyPines
Therapeutics, Inc. (Nasdaq: TPTX) today announced the initiation of a Phase
IIb clinical trial for its lead product candidate, tezampanel, a novel pain
compound in development for the treatment of acute migraine. An
AMPA/kainate (AK) receptor antagonist, tezampanel offers a non-narcotic,
non-vascular approach to the management of headache pain and represents a
potentially promising alternative to current migraine treatments.
The double-blind, placebo-controlled, parallel-group study will enroll
approximately 300 patients and treat a single migraine attack, with or
without aura. Equal numbers of patients will be randomized to one of four
arms and receive a 40 mg, 70 mg, or 100 mg single subcutaneous dose of
tezampanel or placebo. The primary efficacy endpoint is headache pain
relief at two hours post-dose. Secondary efficacy endpoints include pain
free 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 onset. Safety, tolerability
and pharmacokinetics will also be evaluated. The study will be conducted in
approximately 25 centers in the U.S.
"The initiation of our Phase IIb trial with tezampanel is an important
milestone for TorreyPines and a promising development for the millions of
people who suffer with acute migraine," said Neil Kurtz, M.D., President
and Chief Executive Officer of TorreyPines. "We believe that tezampanel
will not only relieve the acute pain associated with migraine, but also
address the underlying mechanisms that precipitate the migraine. Tezampanel
has the potential to offer an important new mechanism of action to the
treatment of migraine."
In previous clinical trials, tezampanel has been administered to more
than 200 healthy adult volunteers or patients. In five Phase IIa,
placebo-controlled trials, tezampanel demonstrated proof of concept in
multiple pain models. In a placebo and active-controlled trial in patients
with acute migraine, the compound, administered intravenously, 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.
TorreyPines' follow-on compound, NGX426, is an oral prodrug of
tezampanel and is in Phase I testing. Both compounds may effectively
relieve severe and persistent pain through a novel mechanism that may not
impart the side effects and risks associated with currently available
migraine and other chronic pain treatments.
About AK Receptor Antagonists
AK receptor antagonists selectively block transmission of pain signals
mediated through the activation of a subtype of glutamate receptors. 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. Because they do
not block opioid receptors, constrict blood vessels or interact with
systems external to the central nervous system at dosages that are
therapeutically relevant, the safety profile of AK antagonists may offer
important advantages over existing drugs.
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. Approximately 25 percent of migraine sufferers endure at least
one attack per week. In addition to headache pain, migraine attacks are
frequently accompanied by sensitivity to light (photophobia) and sound
(phonophobia), nausea and vomiting. Although once thought to be primarily
caused by vascular changes in the brain, researchers now consider migraine
a neurological disorder. In the U.S., the prescription migraine market is
approximately $2 billion, with the market leader, Imitrex(R), accounting
for approximately half of all sales.
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 migraine; chronic
pain, including neuropathic pain; and cognitive disorders, including
Alzheimer's disease and cognitive impairment associated with schizophrenia.
Further information is available at torreypinestherapeutics.
This press release contains forward-looking statements or predictions.
Such forward-looking statements include statements regarding the potential
for tezampanel and NGX426 as treatments 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
including that TorreyPines Therapeutics may not be able to execute its
integration strategies or realize the expected benefits of its recently
completed merger with Axonyx, Inc. These and other risks which may impact
management's expectations are described in greater detail in the
registration statement on Form S-4, as amended, as filed with the
Securities and Exchange Commission and Axonyx's other SEC reports.
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