HOUSTON, March 23 /PRNewswire-FirstCall/ -- Encysive Pharmaceuticals today announced that Encysive and the U.S. Food and Drug Administration (FDA) have placed TBC3711, the Company's next-generation selective endothelin receptor antagonist entering early clinical studies, on clinical hold. The hold is a result of an unusual finding following dosing with intravenous TBC3711 in a single rat that had displayed abnormalities at baseline. The delay follows a standard 30-day review process associated with the Investigational New Drug (IND) application for the intravenous form of TBC3711. The FDA believes, and the Company agrees, that it requires further review before proceeding with patient dosing. All clinical testing with TBC3711, including oral and intravenous formulations, will be suspended. Encysive will work with the FDA to resolve this issue as quickly as possible.
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. A New Drug Application 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 (EMEA) is currently reviewing a Marketing Authorization Application for approval of sitaxsentan sodium (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 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: resolution of the clinical hold for TBC3711; the results of clinical trials with respect to TBC3711; the availability of sufficient funds to continue research and development efforts; 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.
