TorreyPines says upcoming milestones include phase 2b clinical trial of tezampanel, phase 1 of NGX426

By Jennifer Lanning Drey

Eugene, Ore., June 12 - TorreyPines Therapeutics' expected milestones during the next 12 months include starting a phase 2b clinical trial of tezampanel, its lead product candidate for chronic pain, and beginning phase 1 clinical trials of NGX426, according to Dr. Neil Kurtz, president and chief executive officer of TorreyPines.

The company will file an Investigational Drug Application with the Food and Drug Administration for NGX426 this year, Kurtz said in a presentation on Monday at the Pacific Growth Equities Life Science Growth Conference.

In addition, TorreyPines plans to report data from a phase 1 single dose study of NGX267 in elderly patients with Alzheimer's and begin a multiple dose phase 1 study of NGX267, said Kurtz.

Following TorreyPines' merger with Axonyx, Inc., which was announced on Thursday, TorreyPines has also announced plans to evaluate whether Phenserine, a drug developed by Axonyx that failed in February 2005 to differentiate from placebo, still has potential, he said.

Together, TorreyPines and Axonyx have a central nervous system pipeline with eight pre-clinical or clinical product candidates focused on novel therapeutics for neurological diseases and disorders. Two product candidates are for pain and six are for Alzheimer's.

"Both companies are in large, underserved, growing markets, said Kurtz on Monday.

TorreyPines' lead product, tezampanel, continues to advance toward the marketplace, he said. The molecule has undergone seven clinical trials, two of which were phase 2 clinical trials and the other five were proof of concept trials, for treatment of migraines. Tezampanel is a non-opioid, nonvascular approach to chronic pain.

"We are talking about the potential introduction of a novel class of pain molecules with efficacy equivalent to the opioid," Kurtz said.

Tezampanel is administered by injection, which could give it an advantage among migraine patients, who often experience nausea or vomiting, he said.

TorreyPines will begin its first studies of NGX426, the oral form of tezampanel, in humans in the second half of the year, he said.

"With tezampanel and 426, we believe we will be able to address a number of very large market segments," Kurtz said.

"Once we have tezampanel and 426, we believe we will be able to address a number of very large market segments.

TorreyPines is a San Diego-based biopharmaceutical company that discovers and develops small molecule drugs to treat diseases and disorders of the central nervous system.

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