LA JOLLA, Calif., June 4 TorreyPinesTherapeutics, Inc. (Nasdaq: TPTX) today announced it has initiated a clinicaltrial to evaluate the analgesic effect of NGX426, the oral prodrug of its leadproduct candidate, tezampanel.
The randomized, double-blind, placebo-controlled Phase I trial will enroll18 healthy volunteers at a single center in the United States. The trial isdesigned to evaluate the compound's safety and tolerability and to assess thetime of onset, magnitude and duration of its analgesic effect. Specifically,the study will evaluate the effect of NGX426 on hyperalgesia, an abnormallyincreased pain state, and allodynia, pain resulting from normally non-painfulstimuli to the skin, induced by intradermal injections of capsaicin. Theprimary endpoint is subject self-report of spontaneous pain following theinjection of capsaicin.
"We believe there is a substantial commercial opportunity for NGX426 as anovel, oral analgesic," said Neil Kurtz, M.D., President and Chief ExecutiveOfficer of TorreyPines Therapeutics. "Data we have obtained in our ongoingPhase I maximum tolerated dose study demonstrate that the drug iswell-tolerated at single doses up to and including 210 mg and that NGX426 israpidly converted to tezampanel. Moreover, this capsaicin study, ifsuccessful, will enable us to further take advantage of the versatility ofNGX426 and the overall tezampanel franchise."
Subjects in the trial, which involves the recognized and validatedcapsaicin-induced pain model, will receive single doses of 90 mg and 150 mg ofNGX426 versus placebo in a three-way crossover design.
Tezampanel is the first AMPA/kainate-type glutamate receptor antagonist tobe studied in clinical trials for chronic pain. Glutamate receptors mediatethe functioning of glutamate, an important excitatory neurotransmitter. Whilenormal glutamate production is essential, excess glutamate production, eitherthrough injury or disease, can have a range of pathological effects. By actingat both the AMPA and kainate receptor site to competitively block the bindingof glutamate, tezampanel and its oral prodrug, NGX426, have the potential totreat a number of diseases and disorders. These include migraine and otherforms of chronic pain such as neuropathic pain, muscle spasticity andrigidity, thrombosis, epilepsy, Parkinson's disease and a condition known ascentral sensitization, a persistent state of hypersensitivity to pain that isa core component of many pain conditions.
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. is a biopharmaceutical company committed toproviding patients with better alternatives to existing therapies through theresearch, development and commercialization of small molecule compounds. Thecompany's goal is to develop versatile product candidates, each capable oftreating a number of acute and chronic diseases and disorders such asmigraine, chronic pain, muscle spasticity and rigidity, xerostomia andcognitive disorders. The company is currently developing four productcandidates: two ionotropic glutamate receptor antagonists and two muscarinicreceptor agonists. Further information is available athttp://www.torreypinestherapeutics.com.
This press release contains forward-looking statements or predictions.Such forward-looking statements include, but are not limited to, statementsregarding the potential for NGX426 as a novel, oral analgesic and thepotential for tezampanel and NGX426 as treatments for migraine and other formsof chronic pain such as neuropathic pain, muscle spasticity and rigidity,thrombosis, epilepsy, Parkinson's disease and central sensitization. Suchstatements are subject to numerous known and unknown risks, uncertainties andother factors, which may cause TorreyPines' actual results to be materiallydifferent from historical results or from any results expressed or implied bysuch forward-looking statements,