Navigation Links
TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
Date:8/19/2007

- Top Line Results Expected to Be Reported in 4Q 2007 -

LA JOLLA, Calif., Aug. 6 /PRNewswire-FirstCall/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that it has completed enrollment in its Phase IIb clinical trial of tezampanel for the treatment of acute migraine headache. Tezampanel is an AMPA/kainate (AK) receptor antagonist that offers a non-opioid, non-vascular and non-serotonergic approach to the management of pain and represents a potentially new and promising alternative to current migraine treatments.

The clinical trial is a double-blind, placebo-controlled, multi-center trial that reached its targeted enrollment of 300 patients suffering a single migraine attack, with or without aura. Patients are randomized to one of four arms and receive a 40 mg, 70 mg, or 100 mg single, subcutaneous dose of tezampanel or placebo. The purpose of the trial is to identify a dose, or a range of doses, that could be used in a Phase III development program for tezampanel in acute migraine. The primary efficacy endpoint for the trial is headache pain relief at two hours post-dose. Secondary efficacy endpoints include pain free status 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 treatment onset. Safety, tolerability and plasma pharmacokinetic data will also be evaluated.

"Completing enrollment in our Phase IIb trial with tezampanel is an important milestone for us," said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines. "We believe tezampanel has the potential to offer migraine patients an important new treatment option with a novel mechanism of action and we remain on track to announce top line results from the study during the fourth quarter of this year."

In previous clinical trials, tezampanel has been administered to more than 200 healthy adult volunteers or patients. In five Phase IIa, placebo-controlled trials using intravenous administration, tezampanel demonstrated proof of concept in multiple pain models. In one placebo and active-controlled clinical trial in patients with acute migraine, the compound 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.

About AK Receptor Antagonists

AMPA/kainate (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 bind to opioid receptors, directly bind to serotonin receptors or constrict blood vessels, the safety profile of AK antagonists may offer important advantages over existing drugs to treat migraine and other chronic pain conditions.

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. In addition to headache pain, migraine attacks are frequently accompanied by photophobia, phonophobia, nausea, and vomiting. Although once thought to be primarily caused by vascular changes in the brain, some researchers now consider migraine a neurological disorder.

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 chronic pain, including migraine and neuropathic pain; and cognitive disorders, including Alzheimer's disease and cognitive impairment associated with schizophrenia. 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 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. 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.


'/>"/>
SOURCE TorreyPines Therapeutics, Inc.

Copyright©2007 PR Newswire.

Related medicine technology :

1. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
2. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
3. CV Therapeutics Identifies Potential Anti-Diabetic Mechanism of Action for Ranexa
4. GTC Biotherapeutics to Webcast Corporate Presentation at the C.E. Unterberg, Towbin Emerging Growth Life Opportunities Conference
5. Fat Kills Cancer: Turning Stem Cells from Fat Tissue into Personalized, Cancer-Targeted Therapeutics
6. A 4-Week Therapy with Transition Therapeutics E1-I.N.T. Leads to Sustained Reductions in Blood Glucose Levels for 6 Months Post-treatment in Type 2 Diabetes Patients
7. Clinical Trial Suggests Bone Marrow Stem Cells Are Useful for Spinal Cord Injury; PrimeCell Therapeutics Provided Pre-Clinical Study
8. Pieris Progresses Development of its Proprietary Biotherapeutics Platform: Successful Demonstration of Dual Targeting With Duocalin(R) Technology
9. Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin for Multiple Sclerosis
10. Orexigen Therapeutics to Present Data on Contrave Impact on Visceral Fat and Insulin Resistance at American Diabetes Association 67th Scientific Sessions in Chicago June 23
11. Allos Therapeutics Reports Results for Phase 3 Enrich Study of Efaproxyn in Women With Brain Metastases Originating From Breast Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/25/2017)... Sept. 25, 2017  EpiVax, Inc., a leader ... and immune-engineering today announced the launch of EpiVax ... of personalized therapeutic cancer vaccines. EpiVax has provided ... access to enabling technologies to the new precision ... lead EpiVax Oncology as Chief Executive Officer. Gad ...
(Date:9/19/2017)... Ky. , Sept. 19, 2017   ZirMed Inc ... predictive analytics, today announced that it has been ranked #1 ... Black Book™ Rankings 2017 User Survey. ZirMed was ... solution for large hospitals and medical centers over 200 beds ... Black Book,s healthcare technology user survey history. ...
(Date:9/12/2017)... LAKES, N.J. , Sept. 12, 2017  Consumer reviews on ... Embrace Hearing as the number one company for hearing aids, ... ReSound™ and fifteen other brands. ... Embrace Hearing Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that provides ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ProVest Insurance Group, a family ... and Raleigh regions, is organizing an extended charity drive to benefit the family ... abnormality. , After struggling since birth with several health challenges, T.J. was later ...
(Date:10/13/2017)... ... October 13, 2017 , ... The International Association of Eating ... excellence for the field of eating disorders, announces the opening of early registration ... Orlando, Florida at the Omni Resort at ChampionsGate. , The annual ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Many families have ... many long-term care insurance companies have a waiver for care if the client has ... period, when the family pays for care, is often waived, so the benefits from ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... be giving viewers the lowdown on sciatica in a new episode of "Success ... focuses on current events and innovation and investigates each subject in-depth with passion ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and ... apnea using cutting-edge Oventus O2Vent technology. As many as 18 million Americans ... frequent cessation in breathing. Oral appliances can offer significant relief to about 75 ...
Breaking Medicine News(10 mins):