Neuropathic pain: Second Phase I Clinical Trial Of NGX426

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TorreyPines Therapeutics Initiates Second Phase I Clinical Trial Of

NGX426, A Potential Novel Oral Treatment For Chronic Pain Conditions

http://www.medicalnewstoday.com/medicalnews.php?newsid=63947

TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that

it has initiated a second Phase I clinical trial of NGX426, a novel

product candidate intended to treat chronic pain conditions such as

migraine and neuropathic pain. NGX426 is an oral prodrug of

tezampanel, the company's parenteral product candidate currently in

a Phase IIb clinical trial for acute migraine.

The double-blind, placebo-controlled, clinical trial will evaluate

the safety, tolerability and pharmacokinetics of NGX426 to determine

the maximum safe and well-tolerated oral dose. Approximately 60

healthy adult volunteers, enrolled in sequential, dose-escalating

cohorts, will receive placebo or a single dose of NGX426. The trial

is intended to evaluate doses of NGX426 ranging from 40 mg up to the

maximum tolerated dose. In a previous Phase I trial, completed in

November 2006, NGX426 was well tolerated at doses up to 30 mg and

pharmacokinetic analyses confirmed that it was rapidly converted to

tezampanel.

" This second Phase I trial for NGX426 is an important next step in

establishing the safety and tolerability of this potential new

treatment for chronic pain conditions such as migraine, " said Neil

Kurtz, M.D., President and Chief Executive Officer of

TorreyPines. " As an oral prodrug of tezampanel, NGX426 broadens our

portfolio by providing an additional route of administration to

potentially address the varied and unmet needs of pain sufferers. We

look forward to moving ahead with our clinical program. "

Tezampanel and NGX426 are AMPA/kainate (AK) receptor antagonists

that potentially offer a non-narcotic, non-vascular approach to the

treatment of chronic pain, including migraine. AK receptor

antagonists selectively block transmission of pain signals mediated

through the activation of glutamate receptors. These receptors play

a critical role in the development of central sensitization

phenomena -- a key component of many chronic pain conditions,

including migraine and neuropathic pain. As AK receptor antagonists,

tezampanel and NGX426 may effectively relieve severe and persistent

pain through a novel mechanism of action without imparting the side

effects and risks associated with currently available treatment

options for chronic pain, including migraine. Five Phase IIa, double-

blind, placebo-controlled trials have demonstrated that tezampanel,

administered intravenously, was more effective than placebo in

relieving pain symptoms across multiple pain models, including

migraine.