HOUSTON, Nov. 5, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals, Inc. (Nasdaq:ENCY) today announced that open label observational data from Columbia University suggests that sitaxsentan (THELIN), a selective endothelin A receptor antagonist, may improve symptoms associated with Eisenmenger syndrome (ES). The analyses were presented today at the American Heart Association (AHA) Scientific Sessions 2007 meeting in Orlando.
A retrospective chart review was performed on 14 consecutive ES patients (10 females, 4 males; age 27 +/- 11 years) initiating open label sitaxsentan therapy (100 mg tablets daily) at Columbia University between 2002 and 2006. Baseline data were compared to short- and long-term follow-up data at 12 weeks and at approximately one year. There was a significant decrease in the pulmonary vascular resistance (PVR) to systemic vascular resistance (SVR) ratio, consistent with pulmonary selectivity in these patients. The improvements in PVR index and six-minute walk distance were not significant. During the one-year follow-up, these ES patients had no significant change in resting systemic arterial oxygen saturation.
"These results suggest that treatment with sitaxsentan is safe and efficacious in patients with Eisenmenger syndrome," commented Dr. Robyn J. Barst, Professor of Pediatrics at Columbia University College of Physicians and Surgeons, and Director, New York Presbyterian Hospital Pulmonary Hypertension Center.
About Eisenmenger Syndrome
Eisenmenger syndrome is a progressive cardiovascular condition that can develop in individuals who have un-repaired congenital heart defects. ES is initially associated with increased pulmonary blood pressure that, if the congenital heart defect(s) is not repaired, results in reversal of the shunt from left to right to right to left with progressive pulmonary vascular disease and progressive cyanosis. ES is linked to multi-organ damage and premature death. There is currently no cure for ES once it is established.
About Encysive Pharmaceuticals
Encysive Pharmaceuticals Inc. is a global 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. To learn more about Encysive Pharmaceuticals please visit our web site: http://www.encysive.com.
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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 decisions by the U.S. Food and Drug Administration regarding whether and when to approve our drug application for THELIN (sitaxsentan sodium), our ability to raise capital to fund cash requirements for future operations, timelines for initiating new trials and completing ongoing clinical trials for sitaxsentan sodium (THELIN), our estimates of the sufficiency of our existing capital resources, as well as more specific risks, trends and uncertainties facing Encysive such as those set forth in its reports on Forms 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks, trends and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore you should not rely on any such forward-looking statements. Furthermore, Encysive undertakes no duty to update or revise these forward-looking statements. The Private Securities Litigation Reform Act of 1995 permits this discussion.