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news.TorreyPines Therapeutics has initiated a Phase I multiple-dose clinical trial to evaluate the safety and tolerability of tezampanel to potentially block pain signals.
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Tezampanel will be given as a subcutaneous injection to healthy male and female volunteers once-daily for four consecutive days. The compound is an AMPA/kainate (AK) receptor antagonist that selectively binds to certain AK receptors to block the transmission of pain signals, according to the company.
Data from this multiple-dose trial will support the continued development of tezampanel for the treatment of migraine, as well as allow TorreyPines to consider expanding the development of tezampanel into additional chronic pain conditions.
The double-blind, placebo-controlled, multiple-dose trial will be conducted at one center in the US. Approximately 30 healthy male and female volunteers, between the ages of 21 and 55, will be enrolled in sequential, dose-escalating cohorts and receive once-daily subcutaneous doses of placebo or 40mg, 70mg or 100mg of tezampanel for four consecutive days. These same dose strengths, given as a single dose subcutaneous injection, are currently being evaluated by TorreyPines in a Phase IIb clinical trial of tezampanel for acute migraine.
“Our Phase IIb trial in migraine has completed enrollment and we are on track to announce top-line results in the fourth quarter of this year. We believe tezampanel represents a potentially new and promising alternative to current treatments for not only migraine but also other pain conditions. Obtaining multiple dose safety and tolerability data will allow us to plan future studies in those chronic painful conditions,” said Neil Kurtz, president and CEO of TorreyPines.
In five Phase IIa, placebo-controlled trials, tezampanel demonstrated proof of concept in multiple pain models. In a placebo and active-controlled clinical trial in patients with acute migraine, the compound, administered intravenously, achieved statistical significance on all primary and secondary endpoints traditionally required for regulatory approval. These endpoints included pain relief at two hours, pain-free at two hours and relief of nausea, photophobia and phonophobia, the company said.