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| |  Novastan Shows Promising Results in Acute MI HOUSTON, March 17, 1997 -- Positive results of were announced today on two of Texas Biotechnology Corporation's multi-center Phase II studies of Novastan(R) (argatroban for injection) as adjunctive therapy to thrombolytic agents (t-PA or streptokinase) in acute myocardial infarction. ARG-231 (Myocardial Infarction Novastan t-PA or MINT) data were presented at a company-sponsored investigator's meeting on Sunday, March 16. ARG-230 (Argatroban Myocardial Infarction or AMI) data are included in today's Late Breaking Clinical Trials session at the 46th Annual American College of Cardiology meeting, both in Anaheim. As presented by I.K. Jang, M.D., principal investigator, Massachusetts General Hospital, results of the ARG-231 trial demonstrated a safety benefit and a statistically significant improvement in coronary artery reperfusion by 29% at the highest dose as compared to heparin (p=0.02) based on the TIMI Frame Count, an objective measure of artery reperfusion. The trial, which evaluated the potential of Novastan to accelerate reperfusion in coronary arteries, was a double-blind, randomized angiographic reperfusion study of Novastan as adjunctive therapy with t-PA. In the study, 120 patients were randomized to receive either heparin at 15 IU/kg or Novastan at 1 or 3 mcg/kg/minute. In Fall 1996, a companion angiographic trial (ARG-230A) of the same design with streptokinase in 180 patients demonstrated improvement of coronary artery reperfusion by 34% compared to placebo within a six-hour therapeutic window, and by 52% if given within three hours of symptom onset (p=0.03). "The combination of t-PA and argatroban, particularly in late-presenting patients, appears to be far superior than the combination of t-PA and heparin," Dr. Jang said. "While there are several investigational approaches to improving reperfusion rates, including the novel mutant t-PA's and other new thrombolytics, it seems that argatroban, as a new adjunctive therapy has been demonstrated to increase 90 minute patency, known to have close correlation to left ventricular function and mortality. This may be due to the drug's mechanism of action -- blocking thrombin and subsequent inhibition. As presented today at the ACC conference by Pierre Theroux, M.D., principal investigator, Montreal Heart Institute, results of the ARG-230 trial demonstrated no evidence of increased bleeding risk (stroke, major bleeding) versus placebo. The randomized, double-blind, placebo-controlled trial ("ARG-230") was designed to assess safety, as well as effect on a 30-day composite endpoint, which included recurrent myocardial infarction (MI), urgent angioplasty (PTCA) or coronary bypass (CABG), shock/congestive heart failure and death. In the trial, a total of 900 patients were dosed at the rate of 1 or 3 mcg/kg/minute of Novastan or placebo, and received 1.5 million units of streptokinase (SK). "Given the strong safety profile of this drug and the fact that we can see these are the best results shown to date with a direct thrombin inhibitor, we believe that there is room to test with even higher doses," he added. Novastan is a small molecule direct thrombin inhibitor being developed by Texas Biotechnology in the U.S. and Canada for use in the intravenous anticoagulant market as an adjunct to thrombolytic therapy and for the treatment of heparin-induced thrombocytopenia (HIT). Data from the pivotal Phase III trial for Novastan in its initial indication, HIT, is expected to be reported in the second quarter of 1997. Texas Biotechnology Corporation is developing a new generation of therapeutics focused on preserving the functional integrity of the vascular system.
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