CHICAGO, Oct. 24, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) today announced that data from a long-term study with sitaxsentan sodium 100 mg tablets (THELIN(tm)) in patients with pulmonary arterial hypertension (PAH) were presented today at the annual meeting of the American College of Chest Physicians (CHEST), being held in Chicago from October 20 through the 25.
The open-label study explored sitaxsentan treatment in 74 PAH patients at six Canadian PAH centers. Patients were given sitaxsentan 100 mg once-daily and were followed for at least one year. A large portion of the 74 patients, 26 of them, or 35 percent, were treated with sitaxsentan after previously discontinuing treatment with bosentan (Tracleer(r)) due to limited efficacy or liver toxicity.
Results
Estimated Kaplan-Meier survival in the study was 98 percent and 96 percent in PAH patients treated with sitaxsentan for one and two years, respectively. After one year of treatment, six-minute walk distance (6MWD) improved by 22 meters from a baseline of 363 meters. The World Health Organization (WHO) functional class improved by one class in 15 patients, and declined by one class in three patients. A total of 18 of 74 patients, or 24%, discontinued sitaxsentan treatment in the study, including five due to abnormal liver function tests, three due to death, eight due to worsening PAH, and two due to patient decision/noncompliance. Of the 74 patients, 46 patients (62 percent) remained on sitaxsentan monotherapy treatment at 72 weeks. Clinical worsening was similar in patients previously treated with bosentan (19 percent) versus those not previously treated (17 percent).
Of the patients in the study, 46 percent were diagnosed with idiopathic PAH, 37 percent as PAH associated with a connective tissue disease, and 16 percent had congenital heart disease-associated PAH. The majority of patients were either functional class II (32 percent) or functional class III (60 percent) at the start of the study.
"These results show that long-term sitaxsentan treatment is associated with a significant clinical and functional capacity benefit after one year of treatment," commented Sanjay Mehta, M.D., Associate Professor of Medicine and Director of the Southwestern Ontario Pulmonary Hypertension Clinic at the University of Western Ontario, London, Ontario. "The data confirm previous studies and clinical experience showing that sitaxsentan is an important therapeutic option in the growing selection of treatments for patients with PAH."
For more information about the American College of Chest Physicians (CHEST) and CHEST 2007, please visit www.chestnet.org
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(tm) (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(tm)), 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.