Friday February 8, 7:00 am Eastern Time
Press Release
SOURCE: Texas Biotechnology Corporation
Retrospective Study Shows Argatroban Benefit in Acute Ischemic Stroke Patients With HIT at International Stroke Conference
A Second Conference Poster Describes Design of ARGIS-I: A Randomized Placebo-Controlled Study to Determine the Safety and Efficacy of Argatroban In Acute Ischemic Stroke
SAN ANTONIO and HOUSTON, Feb. 8 /PRNewswire-FirstCall/ -- At the 27th International Stroke Conference held February 7-9 in San Antonio, clinical investigators for Texas Biotechnology Corporation (Nasdaq: TXBI - news) presented a retrospective analysis suggesting positive clinical effects for Argatroban in acute ischemic stroke in patients with heparin-induced thrombocytopenia (HIT).
HIT is an immune-mediated condition that can cause blood clots leading to stroke, amputation of limbs and death. Patients who develop HIT must be discontinued from heparin therapy. Argatroban, a direct thrombin inhibitor anticoagulant, was approved by the U.S. Food & Drug Administration as an anticoagulant therapy for the prophylaxis or treatment of thrombosis in patients with HIT in November 2000. Argatroban has also been approved in Japan as a treatment for ischemic stroke since 1996.
Reduction in Stroke-Associated Mortality in Patients with Heparin-Induced Thrombocytopenia after Treatment with the Direct Thrombin Inhibitor Argatroban
Marian P. LaMonte, M.D., M.S.N., Assistant Professor of Neurology and Surgery, University of Maryland School of Medicine, and Director, The Maryland Brain Attack Program, University of Maryland Medical Center, Philip M. Brown, M.D., J.D., Texas Biotechnology and Kurt L. Berens, Texas Biotechnology presented a retrospective analysis involving 812 Argatroban-treated HIT patients and 193 historical control HIT patients from three multi-center Phase III clinical studies evaluating Argatroban as a treatment for HIT. The objective of the analysis was to compare the incidence of stroke in HIT and to assess the effect of Argatroban on HIT patients compared with historical control patients. Historical control patients were typically treated by heparin discontinuation and/or oral anticoagulation.
In the Argatroban-treated HIT patients, the incidence of stroke-related events was 2.6% (21/812) compared to 4.1% (8/193) in the historical control group. While not statistically significant, this decrease in overall stroke events in the Argatroban-treated patients is viewed as clinically relevant. Most important, stroke-associated mortality in the Argatroban-treated patients was statistically different compared to the historical control patients, 1.0% and 3.1% respectively.
``The ability of Argatroban to significantly reduce the number of deaths associated with stroke was very encouraging. We believe these results, combined with the overall safety profile of Argatroban, and the lack of intracerebral hemorrhage associated with this drug, may be of great value to the treatment of these very ill and underserved patients,'' stated Philip Brown, M.D., J.D., Vice President of Clinical Affairs at Texas Biotechnology. ``These conclusions led to the initiation of ARGIS-I, a rigorous Phase II double-blind, placebo-controlled trial to determine the safety and assess the efficacy of Argatroban as a treatment for ischemic stroke.''
As a direct inhibitor of thrombin, including clot bound thrombin, Argatroban may influence both the primary clot, which caused the stroke, as well as the collateral and microcirculation of the brain in and around the original infarction. Through this mechanism, it is possible that additional clots may be prevented from forming. This effect is thought to be responsible for the reduction of secondary thrombus formation following initiation of Argatroban and the reduction in stroke-associated mortality in this retrospective evaluation.
At the Stroke Conference, researchers also presented a clinical poster detailing the trial design for ARGIS-I.
ARGIS-I: A Randomized Placebo-Controlled, Three Treatment Arm Study to Determine the Safety and Efficacy of Argatroban in Patients with Acute Ischemic Stroke
Dr. LaMonte, the primary investigator for the ARGIS-I trial, stated, ``Time of treatment is a major limiting factor in treating stroke patients. Given this unmet need and our confidence in the therapeutic potential of Argatroban to be used as a safe and effective treatment for ischemic stroke, the ARGIS-I trial is exploring a treatment window from 0-12 hours. A treatment window of 0 to 12 hours would significantly increase the treatment options well beyond the 3 hour limitation associated with t-PA, currently the only approved therapy for stroke.''
ARGIS-I is expected to include 180 ischemic stroke patients and involve over 30 major stroke centers in North America. Argatroban is an anticoagulant that is administered by intravenous infusion. The treatment window under evaluation in the Argatroban trial is within 12 hours of onset of symptoms with data being evaluated in two groups: 0 to 6 hours and 6 to 12 hours. Patients who present within the 0 to 3 hour window who are not candidates for t-PA will also be eligible to participate in the Argatroban trial. Neurologic assessments will be made using traditional and well-accepted measures: the Modified Rankin Scale (mRS), Barthel Index (BI) and National Institute of Health Stroke Scale (NIHSS). These measures will be evaluated throughout the trial. Safety, the primary endpoint for this study, will be assessed in terms of incidence of major bleeding.
Dr. Brown added, ``Patient enrollment for ARGIS-I is progressing well and we look forward to reporting the results of the trial in the second half of 2002.''
Copies of the clinical posters: Reduction in Stroke-Associated Mortality in Patients with Heparin-Induced Thrombocytopenia after Treatment with the Direct Thrombin Inhibitor Argatroban and ARGIS-I: A Randomized Placebo- Controlled, Three Treatment Arm Study to Determine the Safety and Efficacy of Argatroban in Patients with Acute Ischemic Stroke can be accessed on the Texas Biotechnology web site www.tbc.com .
Texas Biotechnology, a biopharmaceutical company focused on the discovery, development and commercialization of novel drugs, is recognized for its expertise in small molecule drug development and vascular biology. Argatroban, its first FDA-approved product, is being marketed by GlaxoSmithKline for heparin-induced thrombocytopenia. Additional studies are seeking to broaden this initial indication for Argatroban in ischemic stroke, angioplasty and hemodialysis. Texas Biotechnology has several other products in clinical development for pulmonary arterial hypertension, congestive heart failure and asthma. To learn more about Texas Biotechnology please go to our web site: www.tbc.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 timing and cost of our clinical trials, attainment of research and clinical goals and milestones of product candidates, attainment of required governmental approval, sales levels of our products and availability of financing and revenues sufficient to fund development of product candidates and operations. In particular, careful consideration should be given to cautionary statements made in the various reports Texas Biotechnology has filed with the Securities and Exchange Commission. The Company undertakes no duty to update or revise these forward- looking statements.
SOURCE: Texas Biotechnology Corporation |
