HOUSTON, Jan. 9 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals today announced the initiation of enrollment in a dose ranging study of TBC3711, the Company’s next-generation, highly selective endothelin receptor antagonist. 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 resistant hypertension.
“As we focus on the anticipated approval and commercialization of Thelin(TM), we continue to step-up activities surrounding our pipeline to fuel the Company’s long-term growth,” commented Bruce D. Given, M.D., President and Chief Executive Officer of Encysive Pharmaceuticals. “Dose ranging TBC3711 is a top priority for the Company, and we see resistant hypertension as an excellent model for doing so.”
Study Details
Diagnosed resistant hypertension patients enrolled in the 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.
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. Endothelin receptor antagonists may prove effective in the treatment of a variety of diseases where the regulation of vascular constriction is important, including resistant hypertension. TBC3711 is a next-generation endothelin A antagonist which possesses high oral bioavailability and is even more selective and potent than Thelin(TM), Encysive’s pulmonary arterial hypertension treatment. TBC3711 is greater than 100,000-fold selective in the targeting of the endothelin A receptor versus the endothelin B receptor.
Hypertension (blood pressure of 140/90 mmHg or higher) affects approximately 50 million individuals in the United States and approximately 1 billion individuals worldwide. A direct relationship exists between increased blood pressure and risk of heart attack, stroke, kidney disease and heart failure. 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 (<140/90 mmHg) in patients who are adhering to a regimen of full doses of three anti-hypertensive drugs, including a diuretic.
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, +1-212-477-9007ext. 27; Media: Dan Budwick of BMC Communications, +1-212-477-9007 ext. 14
Web site: http://www.encysive.com/
