FDA Clears Velapharm's Investigational New Drug -Ind- Application of R-Tofisopam for Irritable Bowel Syndrome.

Business Editors

LAWRENCEVILLE, NJ--(BUSINESS WIRE)--June 24, 2003

Company to Begin Phase 2 Trial for IBS Drug to Treat Both Women and Men

Vela Pharmaceuticals (www.velapharm.com), a privately held company specializing in the "rediscovery" and development of medicines related to the central nervous system (CNS), announced today that the Food and Drug Administration has cleared its investigational new drug application for R-tofisopam - a prospective treatment of Irritable Bowel Syndrome (IBS) for both men and women. This allows VelaPharm to advance its clinical development of R-tofisopam, for which it holds a composition-of-matter patent expiring in 2019.

The company will begin patient recruitment immediately for a Phase 2 human clinical trial at multiple sites throughout the United States. The planned 12-week, double-blind, placebo-controlled study will assess the safety and efficacy of R-tofisopam in men and women with IBS that is either diarrhea-predominant or characterized by alternating diarrhea and constipation.

"We are very pleased that the FDA has allowed us to proceed with the development of this exciting molecule," says Kevin L. Keim, MSc, PhD, President and CEO of VelaPharm. "This represents a major advancement for our company and further demonstrates our ability to find hidden value in drugs through our rediscovery process."

R-tofisopam - recently assigned the official USAN (United States Adopted Name) designation of dextofisopam - is the R-isomer of racemic tofisopam. R-tofisopam has demonstrated significant activity in animal models of stress and gastrointestinal dysfunction. Specifically, R-tofisopam reduced stress-induced ulcer formation, normalized stretch-induced colonic contraction, and reduced visceral hypersensitivity while having little or no effect on basal colonic motility. These data support the potential utility of R-tofisopam for the treatment of conditions in which stress, altered bowel motility, and visceral hypersensitivity may play a role, including IBS.

In two Phase 1 trials in healthy subjects, VelaPharm showed that R-tofisopam was well tolerated at single doses of up to 400 mg and multiple doses of up to 600 mg BID (1200 mg/day), with no clinically meaningful trends in laboratory, vital signs, or ECG findings and little or no impairment of cognition or motor function. VelaPharm plans to use a dose of 200 mg BID in its initial Phase 2 trial in IBS.

Irritable bowel syndrome is a common disorder, with a prevalence of approximately 15% among US adults. IBS is also the most common diagnosis made by gastroenterologists in the United States, accounting for 12 percent of visits to primary care providers, with annual direct medical costs estimated at more than $8 billion.

Common treatments for IBS include antispasmodic agents, antidiarrheals, stool softeners, and high-fiber diets. New treatments include two recently approved products, Lotronex((R)) and Zelnorm((R)). While these new products have shown promise in the treatment of IBS, their use is limited to specific subtypes of IBS, and neither drug is approved for use in men.

"Doctors continue to treat the symptoms, but there are still too few treatment options for women with IBS and currently none for men," says Herbert Harris, M.D., Ph.D., Senior Medical Director of VelaPharm. "The preliminary dextofisopam data give us hope that this drug could provide a much needed alternative for the millions of men and women who suffer from IBS."

About VelaPharm

Vela Pharmaceuticals Inc. (www.velapharm.com), a privately held company, specializes in the "rediscovery" and development of medicines to treat diseases related to the central nervous system (CNS). The company uses its extensive drug development expertise to leverage the value of "known" molecular assets. Investors include JP Morgan Partners, New Enterprise Associates, and Venrock.