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Encysive Pharmaceuticals Presents Thelin(TM) Data at European Society of Cardiology

Posted on: Tuesday, 6 September 2005, 09:00 CDT

HOUSTON, Sept. 6 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals today announced data presentations of Thelin(TM) (sitaxsentan) from the Company's STRIDE clinical trials in pulmonary arterial hypertension (PAH) at the European Society of Cardiology (ESC) 2005 Congress, September 3-7 in Stockholm, Sweden.

"ESC provides us with the opportunity to continue educating physicians throughout Europe on studies regarding Thelin as a potential new treatment for patients suffering from PAH," commented Bruce D. Given, M.D., President and CEO of Encysive Pharmaceuticals. "Our clinical data package is now under review by both European and U.S. regulatory authorities. We are focused on building a stronger worldwide presence for Thelin as we anticipate commercialization in Europe in 2006."

Data from STRIDE-2, Encysive's second pivotal Phase III trial for Thelin, was highlighted Sunday, September 4 in a Featured Research Session entitled, "STRIDE-2 Trial: A Placebo-Controlled Study for Sitaxsentan in Pulmonary Arterial Hypertension" (N. Galie, M.D., et al.); Abstract 761.

Four additional abstracts were also presented during the ESC Poster Sessions on Sunday, September 4:

* "Sitaxsentan Treatment for Patients with Pulmonary Arterial Hypertension (PAH) Failing Bosentan Treatment Due to Lack of Efficacy" (R. Benza, M.D., et al.); Abstract P596 * "Sustained Efficacy with the Highly Selective Orally-Active Endothelin-A Receptor Antagonist, Sitaxsentan, After Two Years of Therapy in Patients with Pulmonary Arterial Hypertension" (D. Langleben, M.D., et al.); Abstract P600 * "Sitaxsentan for Pulmonary Arterial Hypertension (PAH) Patients with Clinical Deterioration or Significantly Abnormal Liver Function Test on Bosentan" (D. Ivy, M.D., et al.); Abstract P597 * "Sitaxsentan Improves 6MW and Hemodynamics in Patients with Pulmonary Arterial Hypertension (PAH) Related to Connective Tissue Disease (CTD)" (V. McLaughlin, M.D., et al.); Abstract P598

Additionally, the Company supported, via an unrestricted educational grant, a symposium entitled, "New Therapies and Approaches in the Treatment of Pulmonary Arterial Hypertension," on Monday, September 5. Chairing the event were Nazzareno Galie, M.D., Associate Professor of Cardiology, and Head of Pulmonary Hypertension Centre, Institute of Cardiology, University of Bologna, Italy and Gerald Simonneau, M.D., Head, Department of Pulmonary Disease, Hopital Antoine Beclere, Paris.

For more information about the European Society of Cardiology 2005 Congress, please visit http://cic.escardio.org/Welcome.aspx?eevtid=11 .

About Thelin 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.

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 media, Dan Budwick of BMC Communications, +1-212-477-9007ext. 14; or Marcy Strickler of The Trout Group, +1-212-477-9007 ext. 27, bothfor Encysive Pharmaceuticals

Web site: http://www.encysive.com/http://cic.escardio.org/Welcome.aspx?eevtid=11

Source: PRNewswire-FirstCall

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