Encysive Pharmaceuticals Announces Presentation Of New STRIDE-2X Data At EULAR Congress
HOUSTON, June 22 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals today announced the presentation of new STRIDE-2X data evaluating Thelin(TM) (sitaxsentan sodium) in pulmonary arterial hypertension (PAH) at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Amsterdam, The Netherlands. STRIDE-2X is the open-label, one-year extension study for the Company's 18-week placebo- controlled Phase III pivotal trial, STRIDE-2.
Data from a subset analysis, entitled, "Comparison of Sitaxentan and Bosentan in Pulmonary Arterial Hypertension Associated with Connective Tissue Diseases (CTD)," (Abstract FRI0354) will be presented by Kristin B. Highland, M.D., Assistant Professor, Division of Pulmonary, Critical Care, Allergy, and Clinical Immunology at the Medical University of South Carolina on Friday, June 23, during a poster session beginning at 12:15 p.m. CEST.
A second Thelin abstract, entitled, "Sitaxsentan, A Selective Endothelin-A Receptor Antagonist, Improves Exercise Capacity in PAH Associated with CTD," (J.R. Siebold, M.D., et al.; Abstract SAT0233) will be presented during a poster session on Saturday, June 24 from 8:15 a.m. - 9:45 a.m. CEST. To view the Thelin abstracts, and for more information about EULAR and the 2006 European Congress of Rheumatology, please visit http://www.eular.org/ .
The New Drug Application for Thelin (sitaxsentan sodium) 100 mg tablets is currently being evaluated by the U.S. Food and Drug Administration (FDA) as a potential new oral treatment for patients with pulmonary arterial hypertension, with a PDUFA date of July 24, 2006. On June 2, the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) delivered a positive opinion recommending the approval of Thelin 100 mg tablets. A final decision for European approval is expected within 90 days of the CHMP opinion announcement.
"Sitaxentan" sodium is the spelling recognized by the World Health Organization for Encysive Pharmaceuticals' sitaxsentan sodium.
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. 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 decisions by the U.S. Food and Drug Administration and other regulatory authorities regarding whether and when to approve our drug applications for Thelin(TM) (sitaxsentan sodium), 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.
Encysive Pharmaceuticals Inc.CONTACT: investors, Ann Tanabe, VP, Investor Relations and CorporateCommunications of Encysive Pharmaceuticals Inc., +1-713-796-8822; or media,Dan Budwick of BMC Communications, +1-212-477-9007, ext. 14, for EncysivePharmaceuticals Inc.; or Marcy Strickler of The Trout Group,+1-212-477-9007, ext. 27, for Encysive Pharmaceuticals Inc.