HOUSTON, Sept. 4, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals (Nasdaq:ENCY) today announced that the Company has completed patient enrollment in the Phase II trial for Sitaxsentan sodium (Thelin(tm)) in the treatment of diastolic heart failure (DHF). DHF is a type of congestive heart failure (CHF).
"We are pleased with the clinical progress of this additional indication for sitaxsentan," said George Cole, President and Chief Executive Officer of Encysive. "DHF is a challenging disease to treat, and physicians and patients have very limited options available. We look forward to results of the trial, expected in the middle of 2008."
Sitaxsentan is being tested on approximately 150 DHF patients at approximately 40 study centers. The primary efficacy objective of the study is change in treadmill exercise time at week 24 of treatment. A Data Safety Monitor Board has conducted two reviews of the Phase II trial with no recommended changes to the study plan.
About Diastolic Heart Failure
Diastolic heart failure occurs when the heart is stiff and cannot relax after contracting. Consequently the heart cannot properly fill with blood, causing blood to back up in the left atrium and lung. Three million Americans have CHF and 500,000 new cases are diagnosed each year. Of these cases, DHF accounts for 40 to 60 percent.
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: 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: the timing for completion of our clinical trials and the results of such trials; decisions by the FDA regarding whether and when to approve our NDA for Thelin(tm); unexpected delays in regulatory approval of Thelin(tm) by the FDA in the U.S. and our other products under development; the unpredictability of the duration and results of regulatory review of new drug applications and investigational new drug applications by the FDA; our estimate of the sufficiency of our existing capital resources; our ability to raise additional capital to fund cash requirements for future operations and the availability of sufficient funds to commercialize Thelin(tm) in the U.S. should it be approved by the FDA, 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.