The trials are being conducted in the U.S., Europe, South Africa, Australia, and New Zealand. Additional countries will be entering the program. The company expects that the trials will be conducted at up to 130 sites worldwide and that approximately 70% of the ASP-I sites and approximately 50% of the ASP-II sites will be located within the U.S. Patients who qualify for enrollment into the clinical trials will receive a two or three-hour intravenous infusion of ancrod or placebo within six hours of stroke onset. If treated within three hours of stroke onset, subjects must have been determined unsuitable for treatment with tPA.
"We have data showing that fibrinogen plays a significant role in influencing stroke outcome. Ancrod directly targets fibrinogen and has the potential to treat strokes by rapidly lowering fibrinogen levels," said David E. Levy, MD, Vice President of Clinical Development for NTI.
"We are aggressively recruiting patients worldwide for the ASP-I and ASP-II studies. We hope by garnering a large patient base for the study we can generate the robust data needed to confirm our new dosing strategy and six hour treatment window for acute ischaemic stroke."
Source: PRNewswire
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