The completed study of 460 patients is one of two parallel Phase III clinical trials being conducted at 36 academic medical centers in the UK, Sweden, the Netherlands, Belgium, Poland and the Czech Republic. The two randomized, placebo-controlled studies, which will enroll a combined total of more than 800 elective orthopedic surgery patients, are designed to evaluate the safety and efficacy of Hemospan in preventing and treating hemodynamic instability, especially hypotension, or low blood pressure, during surgery.
Sangart also announced that enrollment in the second Phase III study is progressing well and is expected to be completed in the near future. Earlier clinical studies indicate that Hemospan’s novel oxygen delivery mechanism has the potential to provide a safe and effective alternative to blood transfusions.
Robert Winslow, chairman, president and CEO of Sangart, said: “This represents a major milestone for Sangart as we continue to gather evidence of Hemospan’s potential to satisfy the significant and growing demand for a safe and effective agent to improve oxygen transport in clinical settings where blood is often transfused.”