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news.TorreyPines Therapeutics, a biopharmaceutical company, has initiated dosing of the first cohort of subjects in a Phase I multiple dose clinical trial of NGX426, the oral prodrug of its most advanced product candidate, tezampanel.
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The trial is designed to evaluate the safety, tolerability and pharmacokinetics of NGX426 when given once daily for five consecutive days. NGX426 has been safely administered to more than 150 healthy adults in single doses from 10 to 210mg. Data from the multiple dose trial will support the development of NGX426 in chronic pain indications such as neuropathic pain.
The double-blind, placebo-controlled, Phase I multiple dose trial is being conducted at a single center in the US. A total of 20 healthy male and female adult volunteers will be enrolled in two sequential dose-escalating cohorts and will receive once daily oral doses of placebo, 90mg or 150mg of NGX426 for five consecutive days.
These same dose strengths of NGX426 are currently being evaluated by TorreyPines in a Phase I single dose capsaicin induced hyperalgesia trial to evaluate the analgesic effect of NGX426. Results from this single dose trial are expected to be announced in December 2008.
Ev Graham, acting CEO of TorreyPines Therapeutics, said: “We are pleased with our development progress for NGX426. This novel, oral, non-opioid product candidate could potentially address significant unmet needs in treating migraine and other forms of chronic pain such as neuropathic pain. The multiple dose trial, as well as the ongoing Phase I capsaicin trial evaluating the analgesic effect of NGX426, will guide us in planning our Phase II program.”