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Biotech / Medical : Indications -- Stroke -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (26)	5/27/2003 8:27:32 PM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 70

Hope this will work. Stroke didn't have any progress for eons. Press Release Source: AstraZeneca AstraZeneca Initiates Major Phase III Clinical Trials of CEROVIVE For Treatment of Patients with Acute Ischemic Stroke Tuesday May 27, 9:42 am ET WILMINGTON, Del., May 27 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN - News) announced today the initiation of two major Phase III pivotal clinical trials to determine the effect of CEROVIVE (R) (also known as NXY-059) on disability and neurological recovery in acute ischemic stroke patients. The clinical trial program, known as the SAINT (Stroke - Acute Ischemic - NXY Treatment) Trials, will compare the efficacy and safety of a 72-hour intravenous infusion of CEROVIVE given within six hours of the onset of symptoms, versus placebo. Two multinational, multicenter, double-blind, randomized, placebo- controlled parallel-group studies will be enrolling more than 3000 patients. The SAINT-I trial will involve 200 centers across 24 countries in Europe, Asia, Australia and South Africa. The SAINT-II trial will involve patients from approximately 150 sites in the United States, Canada and South America. "Acute stroke is an area with substantial unmet need for new effective therapies," said Bill Bastain, Global Vice President, Neuroscience Research and Development, AstraZeneca. "AstraZeneca views acute stroke as a treatable emergency and is fully committed to progressing the evaluation of the safety and efficacy of CEROVIVE in large patient populations." CEROVIVE, a nitrone with free radical trapping properties, is a drug under development that has been licensed from Renovis, Inc. of South San Francisco, California. Initiation of the SAINT trials is based on data from animal models of acute ischemic stroke in both rodents and small primates. In the rodent models, CEROVIVE was administered as late as five hours(1) after ischemia and in the latter models as late as four hours(2) after a permanent ischemic insult, where both short term (3 weeks) and long term (10 weeks) functional outcome was assessed as well as the extent of brain injury. Phase I/II trials including two trials(3)(4) in acute stroke patients have been completed to determine the appropriate dose and tolerability of CEROVIVE. The data from the animal models and phase I/II trials have facilitated the initiation of the phase III trials of CEROVIVE in acute ischemic stroke.