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Encysive Pharmaceuticals Announces New STRIDE-2 Data Presented at American Thoracic Society International Conference

Posted on: Monday, 23 May 2005, 12:01 CDT

HOUSTON, May 23 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals today presented additional data from STRIDE-2, the Company's second randomized, pivotal Phase III clinical trial of Thelin(TM) (sitaxsentan) for the treatment of pulmonary arterial hypertension (PAH) at the annual International Conference of the American Thoracic Society (ATS) in San Diego. The data was presented in an oral session by Robyn J. Barst, M.D., Professor of Pediatrics at Columbia University College of Physicians and Surgeons, and Director, New York Presbyterian Hospital Pulmonary Hypertension Center.

"We are very pleased with the clinical results of our second-generation, selective endothelin antagonist, whether compared to placebo or to bosentan, the only approved oral product for pulmonary arterial hypertension," commented Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. "Data from STRIDE-2 and our other Phase II and III studies will form the basis of our New Drug Application, scheduled to be submitted to the U.S. Food and Drug Administration this month."

Thelin met the primary endpoint in STRIDE-2 of improved six-minute walk distance (6MW). The Thelin 100 mg group saw a statistically significant increase of 31.4 meters over placebo (p=0.03). Bosentan increased the 6MW over placebo by 29.5 meters (p=0.05). At the 18-week mark, patients on Thelin 100 mg appeared on average to continue improving from week 12, while those taking bosentan trended down beyond week 12. Thelin 100 mg improved WHO functional class versus placebo (p=0.04) while bosentan did not. Dr. Barst also reported on time to first clinical worsening, in which Thelin trended toward a benefit over both bosentan (p=0.08) and placebo (p=0.08). A 50 mg dose of Thelin was also evaluated to explore the lower end of the dose response curve but did not achieve statistical significance versus placebo, and the Company does not anticipate seeking registration for this dose in adults.

The 100 mg dose of Thelin was associated with a 3% rate of liver function abnormality in the 18-week study, compared to 11% for bosentan and 6% for placebo. Liver enzyme abnormalities reversed in all Thelin and bosentan cases.

The most frequent adverse events that occurred in patients receiving Thelin, which were more common than in placebo-treated patients, were headache, edema, nausea, upper respiratory tract infection, dizziness, insomnia, nasopharyngitis, and nasal congestion. Because Thelin inhibits the metabolism of warfarin, a decreased dose of warfarin is needed when co- administered with Thelin.

About STRIDE-2

STRIDE-2 was an 18-week Phase III, randomized, double-blind placebo- controlled safety and efficacy study of Thelin with an open-label bosentan arm in patients with PAH. Patients were randomized to receive one of four treatments: 50 mg Thelin once daily; 100 mg Thelin once daily; placebo once daily; or bosentan twice daily. A total of 246 patients were enrolled at 55 centers in North America, Europe, Israel and Australia.

Investor and Analyst Webcast Information

The Company will hold a live investor and analyst presentation today at ATS to be made accessible via webcast, beginning at 12:30 p.m. PT (3:30 p.m. ET). To participate, go to the Company's web site, http://www.encysive.com/ .

About Thelin and PAH

Thelin is a small molecule that blocks the action of endothelin, a potent mediator of blood vessel constriction and growth of smooth muscle in vascular walls. Endothelin receptor antagonists may prove to be effective in the treatment of a variety of diseases where the regulation of vascular constriction is important. Thelin is 6,500-fold selective in the targeting of the endothelin A receptor versus the endothelin B receptor.

Pulmonary arterial hypertension (PAH) is a condition that involves high blood pressure and structural changes in the walls of the pulmonary arteries, which are the blood vessels that connect the right side of the heart to the lungs. PAH causes shortness of breath, limits activity, and is eventually fatal unless treated successfully with heart/lung or lung transplantation. PAH is estimated to afflict approximately 100,000 to 200,000 people worldwide, many of whom are children and young women.

About Encysive Pharmaceuticals

Encysive Pharmaceuticals Inc. is a biopharmaceutical company engaged in the discovery, development and commercialization of novel, synthetic, small molecule compounds to address unmet medical needs. Our research and development programs are predominantly focused on the treatment and prevention of interrelated diseases of the vascular endothelium and exploit our expertise in the area of the intravascular inflammatory process, referred to as the inflammatory cascade, and vascular diseases. We have successfully developed one FDA-approved drug, Argatroban, for the treatment of heparin-induced thrombocytopenia that is marketed by GlaxoSmithKline. Our lead drug candidate, Thelin(TM) (sitaxsentan), is an endothelin receptor antagonist that has completed final Phase III clinical trials for the treatment of pulmonary arterial hypertension. In addition, we have earlier stage clinical product candidate in development, TBC3711, a next generation endothelin receptor antagonist. To learn more about Encysive Pharmaceuticals please visit our web site: http://www.encysive.com/ .

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Among those risks, trends and uncertainties are our estimate of the sufficiency of our existing capital resources, our ability to raise additional capital to fund cash requirements for future operations, timelines for initiating new clinical trials, planned announcements of clinical data, the possibility of obtaining regulatory approval, our ability to manufacture and sell any products, potential drug candidates, their potential therapeutic effect, market acceptance or our ability to earn a profit from sales or licenses of any drug candidate, our ability to discover new drugs in the future, and our ability to establish future collaborative arrangements. In particular, careful consideration should be given to cautionary statements made in the various reports Encysive, including as Texas Biotechnology Corporation, has filed with the Securities and Exchange Commission. Encysive undertakes no duty to update or revise these forward-looking statements.

Encysive Pharmaceuticals Inc.

CONTACT: investors, Ann Tanabe of Encysive Pharmaceuticals Inc.,+1-713-796-8822; or media, Dan Budwick of BMC Communications, +1-212-477-9007,ext. 14; or Marcy Strickler of The Trout Group, +1-212-477-9007, ext. 27, bothfor Encysive Pharmaceuticals Inc.

Web site: http://www.encysive.com/http://www.thoracic.org/ic/ic2005/conference.asp

Source: PRNewswire-FirstCall

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