Press Release
SOURCE: Texas Biotechnology Corporation
Preclinical Results With Argatroban Suggest Expanded Treatment Window For Ischemic Stroke When Used in Combination With tPA
HOUSTON and DETROIT, May 9 /PRNewswire/ -- Texas Biotechnology Corporation (Amex: TXB - news) and Henry Ford Health Systems today announced the presentation of positive preclinical stroke data for Texas Biotechnology's Argatroban at the Society for Academic Emergency Medicine (SAEM) in Atlanta. Results from this study demonstrated that Argatroban and tPA, when used in combination at four hours after the onset of an embolic stroke, reduced ischemic lesion size without increasing gross cerebral hemorrhage rates (bleeding into the brain) in rats. This preclinical stroke model closely simulates the pathophysiology of humans experiencing ischemic stroke.
In this study there was a statistically significant reduction in lesion size without any increase in bleeding in the Argatroban + tPA treated rats versus the tPA treated group. (see attached Abstract: Opening the Window of Opportunity for Treatment of Stroke with Argatroban and tPA).
Michael Chopp, Ph.D., Professor & Vice Chairman, Neurology at the Henry Ford Hospital, the principal investigator for this study, stated, ``Our research demonstrated that combination therapy of Argatroban, a direct thrombin inhibitor, and tPA at four hours has the potential to open the window of opportunity for treatment of stroke without increasing intracranial bleeding in this rat model.''
tPA, the only approved drug for ischemic stroke, can only be used within three hours of the onset of a stroke.
Philip Brown, M.D., JD, Vice President of Clinical Affairs at Texas Biotechnology, stated, ``These results represent an important step in furthering our understanding of the potential use of Argatroban as a treatment for ischemic stroke. Validation of the Japanese experience in different animal models gives us greater assurance as we move forward with our clinical trials in stroke.'' Dr. Brown added, ``The three hour treatment window with tPA is extremely limiting and expanding the current treatment window would represent a significant improvement.''
Argatroban has been approved as a treatment for ischemic stroke since 1996 in Japan where it is marketed by Mitsubishi-Tokyo Pharmaceuticals, Inc.
David B. McWilliams, President and CEO of Texas Biotechnology, added, ``The results of this preclinical study add additional momentum to our plan to evaluate Argatroban for additional indications, in this case as a treatment for ischemic stroke -- as monotherapy and possibly in combination with tPA.''
Late last year, Argatroban was approved by the U.S. Food & Drug Administration as an anticoagulant for the prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia (HIT). GlaxoSmithKline is responsible for the sales and marketing of Argatroban in HIT. Texas Biotechnology and Mitsubishi are funding a Phase II trial, the ARGIS-I trial, to evaluate the safety and efficacy of Argatroban as a treatment for ischemic stroke. |
