HOUSTON, Oct. 20 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals today announced that new data from STRIDE-2 and related clinical trials of Thelin(TM) (sitaxsentan sodium) in pulmonary arterial hypertension (PAH) will be presented at the annual meeting of the American College of Chest Physicians (CHEST), to be held October 29-November 3 in Montreal.
Five abstracts were accepted for the meeting, including four oral and one poster presentation. They include:
* “Sitaxsentan Improves Time to Clinical Worsening in Patients with Pulmonary Arterial Hypertension” (Abstract 2614); Presented by David Badesch, M.D., on Monday, October 31, 2:30-4:00 p.m. EST * “Sitaxsentan Therapy in Pulmonary Arterial Hypertension Results in Significantly Fewer Liver Function Abnormalities than Bosentan” (Abstract 2719); Presented by Terrance Coyne, M.D., on Tuesday, November 1, 10:30 a.m.-12:00 p.m. EST * “Sitaxsentan, a Selective Endothelin-A Receptor Antagonist, Improves Exercise Capacity in Pulmonary Arterial Hypertension (PAH) Associated with Connective Tissue Disease (CTD)” (Abstract 2704); Presented by James Siebold, M.D., on Wednesday, November 2, 10:30 a.m.-12:00 p.m. EST * “Warfarin Management in Pulmonary Arterial Hypertension is Similar Between Bosentan, Placebo, and Sitaxsentan” (Abstract 2716; Poster 563); Presented by Terrance Coyne, M.D., on Wednesday, November 2, 12:30 p.m. -2:00 p.m. EST * “Long-term Treatment with Sitaxsentan in Patients with Pulmonary Arterial Hypertension Associated with Connective Tissue Disease (PAH-CTD)” (Abstract 3111); Presented by Reda Girgis, M.D., on Wednesday, November 2, 10:30 a.m.-12:00 p.m. EST
Additionally, the Company is supporting, via an unrestricted educational grant, a Satellite Symposium to be held Tuesday, November 1 from 6:15 p.m. to 9:00 p.m. EST in Salle de Ball Centre, Le Centre Sheraton Montreal Hotel.
For more information about the American College of Chest Physicians and CHEST 2005, please visit http://www.chestnet.org/.
About Thelin(TM) (sitaxsentan sodium) 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.
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. Monthly testing for liver function and pregnancy testing for women of childbearing potential is required for patients receiving Thelin(TM).
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. The NDA for our lead drug candidate Thelin(TM) (sitaxsentan sodium), an endothelin A receptor antagonist for the treatment of PAH, is now under active review by the Cardio- Renal Division of the FDA. The European Agency for the Evaluation of Medicinal Products is currently reviewing a Marketing Authorization Application for approval of Thelin within the European Union. In addition, we have an 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
CONTACT: Investors, Ann Tanabe of Encysive Pharmaceuticals,+1-713-796-8822; or Marcy Strickler of The Trout Group for EncysivePharmaceuticals, +1-212-477-9007 ext. 27; or Media, Dan Budwick of BMCCommunications for Encysive Pharmaceuticals, +1-212-477-9007 ext. 14
