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Multiple Dose Clinical Trial Of TorreyPines Therapeutics' Tezampanel Demonstrates Compound Is Safe And Well-Tolerated
TorreyPines Therapeutics, Inc.
(Nasdaq: TPTX) announced that data from its multiple dose clinical
trial of tezampanel, an antagonist of the AMPA and kainate subgroup of
glutamate receptors, show that the product candidate is safe and
well-tolerated in normal male and female subjects.
These Phase I results support the company's continued development of
tezampanel as a novel therapeutic for chronic pain and expand its potential
therapeutic applications across a variety of persistent conditions in which
activation of glutamate receptors initiates or sustains pathophysiological
processes. These conditions include cancer pain and neuropathic pain, as
well as non-pain conditions such as epilepsy, muscle spasticity and
rigidity, and Parkinson's disease. A recently completed Phase IIb clinical
trial of tezampanel in 306 patients with migraine met its primary endpoint
for pain relief at two hours using a single 40 mg subcutaneous dose. In
five previously conducted placebo-controlled, Phase II trials, an
intravenous formulation of tezampanel demonstrated analgesic effect across
all five studies using a variety of chronic pain models.
The Phase I double-blind, placebo-controlled trial enrolled 30 healthy
male and female subjects in sequential, dose-escalating cohorts. Subjects
received once-daily subcutaneous injections of placebo or 40 mg, 70 mg or
100 mg of tezampanel for four consecutive days, approximating exposure
under steady-state pharmacokinetic conditions. Overall, tezampanel was
well-tolerated. There were no dose-limiting adverse events or
discontinuations from the study and reported adverse events were generally
mild and transient.
"This study is an important step forward in the clinical development of
tezampanel. Our ability to safely deliver multiple doses of tezampanel
means that we can now pursue virtually any indication that requires chronic
dosing," said Neil Kurtz, M.D., President and Chief Executive Officer of
TorreyPines Therapeutics. "There is an emerging appreciation of the
pathological effects of increased AMPA and kainate receptor activation by
glutamate. By blocking both receptors, tezampanel and its oral prodrug,
NGX426, may represent a unique and effective approach to treat a variety of
chronic pain as well as non-pain conditions."
Tezampanel is the first AMPA/kainate antagonist to be studied in
clinical trials for chronic pain. Both tezampanel and NGX426 represent a
novel, non-opiod, non-vascular and non-serotonergic approach to treating
multiple chronic pain conditions. Tezampanel and NGX426 are antagonists of
a subgroup of glutamate receptors referred to as AMPA and kainate. These
receptors are found in areas of the central and peripheral nervous system
that are important for the transmission of pain. For example, during a
migraine attack, levels of glutamate increase and activate these receptors,
facilitating the transmission of pain impulses. Tezampanel, by blocking the
binding of glutamate to these receptors, is believed to inhibit the
transmission of pain signals that lead to migraine headaches. The blockade
of similar receptors in other regions of the brain or spinal cord has been
shown in animal models to attenuate pathophysiological processes such as
the muscle spasticity and rigidity that occurs following stroke and spinal
cord injury, or that may be associated with multiple sclerosis.
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. is a clinical-stage biopharmaceutical
company committed to the discovery, development and commercialization of
small molecules. The company is developing versatile product candidates,
each potentially capable of treating a number of different diseases and
disorders, including chronic pain, muscle spasticity and rigidity,
cognitive disorders and xerostomia, or dry mouth. 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, the potential for NGX426 as a
treatment for migraine, the potential for tezampanel to offer a unique
approach to the management of pain, the potential for tezampanel or NGX426
to offer a unique approach to the management of pain and the potential
timing, development and initiation of future clinical trials of tezampanel
and NGX426. Such statements are subject to numerous risks, and
uncertainties that may cause actual events or results to differ materially
from the company's current expectations. Statements regarding TorreyPines
Therapeutics' product candidates are subject to risks and uncertainties
regarding development, regulatory approval and commercialization, including
whether the results of the Phase IIb trial are predictive of results in
subsequent trials of tezampanel, whether the results of the Phase I trial
are predictive of results in subsequent trials of tezampanel or NGX426,
whether further testing of tezampanel and NGX426 will result in data
sufficient to support regulatory approval, whether AMPA/kainate antagonists
will prove to be safe and effective treatments for migraine and other pain
conditions as well as non-pain conditions, 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 product candidates will be able to improve the signs or symptoms of
their respective clinical indication; whether any of its product 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 Dec. 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
Studiu clinic cu doze multiple de TorreyPines therapeutics "Tezampanel demonstreazã compus este în siguranþã ºi bine tolerat - Multiple Dose Clinical Trial Of TorreyPines Therapeutics' Tezampanel Demonstrates Compound Is Safe And Well-Tolerated - articole medicale engleza - startsanatate