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Biotech / Medical : 3-DIMENSIONAL PHARMACEUTICALS (DDDP) -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (43)	12/10/2001 6:19:02 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 146

Monday December 10, 10:30 am Eastern Time Press Release SOURCE: AstraZeneca AstraZeneca's Investigational Oral Anticoagulant Studied as Alternative to Warfarin for Stroke Prevention Results Presented at American Society of Hematology WILMINGTON, Del., Dec. 10 /PRNewswire/ -- Interim results of a Phase II trial comparing AstraZeneca's investigational oral direct thrombin inhibitor EXANTA (ximelagatran) to warfarin for the prevention of strokes in patients with chronic nonvalvular atrial fibrillation (NVAF) showed 0.9 strokes and 0.4 transient ischemic attacks (TIAs) per 100 treatment years (3 events) for patients on EXANTA and 2.6 strokes and 2.6 TIAs per 100 treatment years (4 events) for patients on warfarin. Results of the SPORTIF IV trial were presented today at the 43rd annual meeting of the American Society of Hematology in Orlando, Florida. Both strokes observed in the patients treated with EXANTA were ischemic and non-fatal. Both strokes observed in the warfarin-treated patients were hemorrhagic and fatal. SPORTIF IV is a long-term, open-label continuation of SPORTIF II, a 12-week randomized dose-finding study. In SPORTIF IV, 125 patients with chronic NVAF and at least one additional stroke risk factor received fixed-dose EXANTA (36 mg bid) and 42 patients received warfarin (dose-adjusted to an INR of 2-3). Patients have been treated for between 21 and 24 months; the study is ongoing. These preliminary results need to be confirmed in larger-scale clinical trials. The incidence of major bleeding was 0.9 per 100 treatment years with EXANTA and 2.6 per 100 treatment years with warfarin. In the combined SPORTIF II/IV clinical trials, liver enzyme levels of at least three times the upper limit of normal were observed in approximately 5 percent of patients treated with EXANTA. None of these patients was symptomatic, and enzyme levels decreased during continued treatment or discontinuation of therapy. EXANTA is the first oral direct thrombin inhibitor under Phase III investigation. The mechanism of action of EXANTA is to inhibit the activity of a clot-forming enzyme called thrombin, which is critical to the final step in the formation of blood clots. Ongoing clinical studies utilize a fixed dose of EXANTA without routine coagulation monitoring. According to the American Heart Association, atrial fibrillation is found in about two million Americans. During atrial fibrillation, the two small upper chambers of the heart, called the atria, quiver instead of beating effectively. Blood in these quivering chambers can pool and clot. If a piece of the blood clot travels to an artery in the brain and becomes lodged, a stroke may result. About 15 percent of strokes in the United States occur in people with atrial fibrillation. AstraZeneca (NYSE: AZN - news) is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15.8 billion and leading positions in sales of cardiovascular, gastrointestinal, oncology, anesthesia (including pain management), central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is an $8 billion healthcare business with more than 10,000 employees. For more information about AstraZeneca please visit astrazeneca-us.com This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2000. SOURCE: AstraZeneca