12 Feb 2009 05:00 AM
First Multiple Dose Clinical Trial Of TorreyPines Therapeutics' Oral Compound NGX426 Demonstrates Compound Is Safe And Well-Tolerated
TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) announced that oral administration of NGX426, an AMPA/kainate-type glutamate receptor antagonist, was safe and well-tolerated in healthy male and female subjects when dosed once daily for five consecutive days.
"The successful completion of this Phase I trial demonstrating the safety and tolerability of NGX426 when dosed over multiple days provides support for pursuing a Phase II program in chronic indications," said Ev Graham, Chief Executive Officer of TorreyPines. "Combined with the positive results from our recently completed Phase I study of NGX426 in a capsaicin induced pain model, we are very encouraged about the potential for NGX426 to treat both acute and chronic pain conditions."
The Phase I double-blind, placebo-controlled trial enrolled 20 healthy male and female subjects in sequential, dose-escalating cohorts. Subjects received once-daily oral doses of either 90 mg or 150 mg of NGX426 or placebo for five consecutive days, approximating exposure under steady-state pharmacokinetic conditions. Overall, NGX426 was well-tolerated. There were no dose-limiting adverse events or discontinuations from the study and reported adverse events were generally mild and transient.
NGX426, an ester prodrug, is an oral form of tezampanel, TorreyPines most advanced product candidate. Pharmacokinetic analyses from two Phase I studies confirmed that when given to humans, NGX426 is rapidly converted to tezampanel, the active moiety. To date, six Phase II, double-blind, placebo-controlled trials have demonstrated that tezampanel, administered either subcutaneously or intravenously, was more effective than placebo in relieving pain across migraine, nociceptive and neuropathic pain models, including a capsaicin-induced pain model. In December 2008, TorreyPines announced that NGX426 demonstrated a statistically significant reduction in spontaneous pain, hyperalgesia (abnormally increased pain state) and allodynia (pain resulting from normally non-painful stimuli to the skin) compared to placebo following intradermal injections of capsaicin in a human experimental model of cutaneous pain, hyperalgesia and allodynia…
"The successful completion of this Phase I trial demonstrating the safety and tolerability of NGX426 when dosed over multiple days provides support for pursuing a Phase II program in chronic indications," said Ev Graham, Chief Executive Officer of TorreyPines. "Combined with the positive results from our recently completed Phase I study of NGX426 in a capsaicin induced pain model, we are very encouraged about the potential for NGX426 to treat both acute and chronic pain conditions."
The Phase I double-blind, placebo-controlled trial enrolled 20 healthy male and female subjects in sequential, dose-escalating cohorts. Subjects received once-daily oral doses of either 90 mg or 150 mg of NGX426 or placebo for five consecutive days, approximating exposure under steady-state pharmacokinetic conditions. Overall, NGX426 was well-tolerated. There were no dose-limiting adverse events or discontinuations from the study and reported adverse events were generally mild and transient.
NGX426, an ester prodrug, is an oral form of tezampanel, TorreyPines most advanced product candidate. Pharmacokinetic analyses from two Phase I studies confirmed that when given to humans, NGX426 is rapidly converted to tezampanel, the active moiety. To date, six Phase II, double-blind, placebo-controlled trials have demonstrated that tezampanel, administered either subcutaneously or intravenously, was more effective than placebo in relieving pain across migraine, nociceptive and neuropathic pain models, including a capsaicin-induced pain model. In December 2008, TorreyPines announced that NGX426 demonstrated a statistically significant reduction in spontaneous pain, hyperalgesia (abnormally increased pain state) and allodynia (pain resulting from normally non-painful stimuli to the skin) compared to placebo following intradermal injections of capsaicin in a human experimental model of cutaneous pain, hyperalgesia and allodynia…
