Data Presented at American Headache Society's Annual ScientificMeeting Show Primary Endpoint Met as Well as Improvement onImportant Secondary Endpoints in Phase IIb Acute Migraine Trial ofTorreyPines Therapeutics' TezampanelCompany's End-of-Phase II Meeting with FDA Set for Sept. 29
LA JOLLA, Calif., June 30, 2008 /PRNewswire/ -- TorreyPines Therapeutics, Inc. today announced that data presented at the 50th Annual Scientific Meeting of the American Headache Society showed that, in addition to meeting the primary endpoint of headache pain relief at two hours, the company's lead AMPA/kainate-type glutamate receptor antagonist, tezampanel, demonstrated improvement on important secondary endpoints in a 306-patient Phase IIb clinical trial in acute migraine headache. Specifically, tezampanel demonstrated improvement in the following secondary endpoints: sustained headache response, absence of nausea or vomiting, absence of phonophobia and absence of photophobia.
"This is our second positive study in acute migraine with tezampanel," said Neil Kurtz, M.D., President and Chief Executive Officer of TorreyPines Therapeutics, who presented the data. "In both studies, we have shown improvement in all of the endpoints that the FDA has indicated will be required for the drug's approval. Earlier this year we conducted a clinical guidance call with the FDA in which the agency said it has no objection with us moving forward with a Phase III study of the 40 mg dose of tezampanel. We have scheduled an end-of-Phase II meeting to discuss the entire Phase III program with the agency on Sept. 29."
In the Phase IIb clinical trial, tezampanel was well tolerated with no reports of serious or medically important adverse events. At the 40 mg dose, the most commonly reported adverse events compared to placebo were injection site pain (5.1 percent vs. 20 percent), injection site burning (3.8 percent vs. 6.7 percent), dizziness (6.4 percent vs. 5.3 percent), somnolence (7.7 percent vs. 6.7 percent) and dry mouth (2.6 percent vs. 5.3 percent). As indicated above, the reported rates of "injection site pain," "injection site burning" and "dry mouth" occurred more frequently in the placebo group.
Tezampanel is the first AMPA/kainate-type glutamate receptor antagonist to be studied in clinical trials for chronic pain, including migraine. Glutamate receptors mediate the functioning of glutamate, an important excitatory neurotransmitter. While normal glutamate production is essential, excess glutamate production, either through injury or disease, can have a range of pathological effects. By acting at both the AMPA and kainate receptor site to competitively block the binding of glutamate, tezampanel and its oral prodrug, NGX426, have the potential to treat a number of diseases and disorders. These include migraine and other forms of chronic pain such as neuropathic pain and fibromyalgia, as well as muscle spasticity and rigidity, thrombosis and epilepsy.
Migraine is a debilitating neurological condition characterized by an intense and disabling episodic headache. According to the National Headache Foundation, nearly 30 million people in the United States suffer from migraines. More than 50 percent of migraine sufferers endure from one to four migraine attacks per month. In addition to headache pain, migraine attacks are frequently accompanied by photophobia, phonophobia, nausea and vomiting.
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. is a biopharmaceutical company committed to providing patients with better alternatives to existing therapies through the research, development and commercialization of small molecule compounds. The company's goal is to develop versatile product candidates each capable of treating a number of acute and chronic diseases and disorders such as migraine, chronic pain, muscle spasticity and rigidity, xerostomia and cognitive disorders. The company is currently developing four product candidates: two ionotropic glutamate receptor antagonists and two muscarinic receptor agonists.
This press release contains forward-looking statements or predictions. Such forward-looking statements include, but are not limited to, statements regarding the potential for tezampanel as a treatment for migraine and other forms of chronic pain such as neuropathic pain and fibromyalgia, as well as muscle spasticity and rigidity, thrombosis and epilepsy. 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, including whether any preclinical studies or clinical trials conducted in the future, will prove successful, and if successful, whether the results can be replicated. These and other risks which may cause results to differ are described in greater detail in the "Risk Factors" section of TorreyPines' annual report on Form 10-K for the year ended December 31, 2007 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.
Posted: June 2008