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Findings Support Continued Development for Chronic Pain and Non-Pain Indications
LA JOLLA, CA, USA | February 5, 2008 | TorreyPines Therapeutics, Inc. (NASDAQ: TPTX) today 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 www.torreypinestherapeutics.com
SOURCE: TORREYPINES THERAPEUTICS |
