HOUSTON, March 21, 2007 (PRIME NEWSWIRE) -- Encysive Pharmaceuticals Inc. (Nasdaq:ENCY) today announced that the first patient has been enrolled into its Phase II dose-ranging study of oral TBC3711, the Company's next-generation, highly selective endothelin receptor antagonist, in resistant hypertension. The 12-week, multi-center, randomized, double-blind, placebo-controlled study will evaluate four once-daily oral doses of TBC3711 in approximately 150 patients with diagnosed resistant hypertension.
"With the commercialization of our lead product THELIN(tm) well underway in the European Union, we're able to focus on advancing our product pipeline," commented Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. "This study is the crucial next step for TBC3711 development and we eagerly await the results."
Study Details
Resistant hypertension patients enrolled in the Phase II study will be randomized to one of four double-blind TBC3711 treatment arms or a placebo arm. Each arm will consist of approximately 30 patients. All study arms will receive once-daily doses of either TBC3711 or placebo. TBC3711 or placebo will be given concomitantly with each patient's current anti-hypertensive regimen. Primary outcome data will consist of blood pressure measurements taken pre-dose and two hours post-dose.
"A selective endothelin receptor antagonist may prove effective in improving persistent vasoconstriction, a hallmark finding of resistant hypertension," said Domenic Sica, M.D., Professor of Internal Medicine and Nephrology, Virginia Commonwealth University, Richmond, Virginia. "I look forward to the study of TBC3711 in the resistant hypertension population, a group of patients who, despite three drug therapy, are still presenting with poorly controlled high blood pressure."
About TBC3711 and Resistant Hypertension
TBC3711 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. TBC3711 is a next-generation endothelin A antagonist which possesses high oral bioavailability and is more selective and potent than THELIN(tm) (sitaxsentan sodium) Encysive's oral treatment for pulmonary arterial hypertension. TBC3711 is greater than 100,000-fold selective in the targeting of the endothelin A receptor versus the endothelin B receptor.
Many individuals can successfully lower blood pressure through lifestyle modifications and/or treatment with one or more approved hypertension drugs. Resistant hypertension is defined as the failure to reach goal blood pressure (less than 140/90 mmHg) in patients who are adhering to a regimen of full doses of three anti-hypertensive drugs, including a diuretic. A direct relationship exists between increased blood pressure and risk of heart attack, stroke, kidney disease and heart failure.
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 U.S. Food and Drug Administration (FDA)-approved drug, Argatroban, for the treatment of heparin-induced thrombocytopenia that is marketed by GlaxoSmithKline. Our endothelin receptor antagonist, THELIN(r)(a), is approved in the European Union and Australia, and is under regulatory review in the United States and Canada. To learn more about Encysive Pharmaceuticals please visit our web site: http://www.encysive.com.
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Note:
(a) THELIN(r) is an E.U. registered trademark of Encysive Pharmaceuticals Inc.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to prospects for regulatory approval of TBC3711 and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "potential," "plan," "believe" or other words and terms of similar meaning. Among the factors that could cause actual results to differ materially from those indicated by such forward- looking statements are: difficulties in obtaining sufficient patient population and clinician support for TBC3711 clinical trials; delays in the timelines for recruiting clinical sites and enrolling patients in TBC3711 clinical trials; unforeseen or significant side effects or other safety issues with respect to TBC3711; any estimates concerning the amount of time necessary to determine whether TBC3711 is effective; production of sufficient quantities of TBC3711 to complete clinical trials; any estimates of the size of the resistant hypertension patient population.; the results of clinical trials with respect to TBC3711; the availability of sufficient funds to continue research and clinical development efforts for TBC3711; as well as more specific risks and uncertainties facing Encysive such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward- looking statements. Furthermore, Encysive does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.