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Novastan Effective Anticoagulant in PTCA Patients With HIT HOUSTON -- April 17, 1997 -- Results of a Phase III clinical trial show Novastan(R) to be an effective alternative to heparin in acute coronary intervention patients with a history of heparin-induced thrombocytopenia (HIT). This trial is a follow-up to a phase II study, ARG-216, in 21 patients, which was reported in November 1996. Data from the 30-patient study, which included those undergoing percutaneous transluminal coronary angioplasty (PTCA), direct atherectomy, or stent placement, showed that all 30 patients met the primary endpoint of ability to successfully complete the procedure while using Novastan as the anticoagulant. Clinically significant bleeding, the most common side effect of anti-coagulation therapy, was noted in only one patient. Texas Biotechnology Corporation, which developed the drug, anticipates using these interventional data as a supplement to its initial NDA submission for non-interventional patients. Texas Biotechnology is currently analyzing data from a pivotal 300-patient trial, ARG-911, which uses Novastan as anticoagulant therapy in non-interventional patients with HIT. This is projected to be the initial claim for Novastan. Texas Biotechnology anticipates announcing results of both the ARG-911 and ARG-310 studies at a satellite symposium during the International Society of Thrombosis and Hemostasis conference in Florence, Italy this June. Novastan is a small molecule direct thrombin inhibitor being developed in the U.S. and Canada for use in the injectable anticoagulant market. The Company has two broad clinical programs for the development of the compound. The first is for HIT, a serious allergic reaction to heparin, the most widely used injectable anticoagulant. Currently, there is no viable alternative in the U.S. to heparin for patients who develop HIT. Texas Biotechnology is also evaluating Novastan as an adjunct to thrombolytic agents including t-PA and streptokinase in acute myocardial infarction. E-mail this page to a friend or colleague! To print, use this version