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news.Sangart has completed enrollment in the second Phase III trial of its lead product, Hemospan. Sangart expects the top line results from this trial to be available in the second half of 2008.
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The 370-patient randomized, double-blind, controlled Phase III study was conducted at 18 clinical sites in six European countries. Together with another Phase III study completed in March, the trials were designed to evaluate the safety and efficacy of Hemospan for preventing and treating hemodynamic instability, particularly hypotension, or low blood pressure, during primary hip replacement surgery.
Extensive preclinical efficacy studies and earlier clinical trials indicate that Hemospan’s novel oxygen delivery mechanism has the potential to enhance oxygenation of ischemic tissues and may provide a safe and effective alternative to blood transfusion, especially when blood is not immediately available.
Robert Winslow, chairman, president and CEO of Sangart, said: “The completed enrollment in this second Phase III trial represents another significant milestone for Sangart as we advance the development of Hemospan.”