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Sangart Receives Approval to Initiate Phase Ib/II Clinical Trial for Hemospan®
SAN DIEGO, CA (December 13, 2002) Sangart, Inc., a biopharmaceutical company developing oxygen transport agents, announced today that it has received approval from the Swedish Medical Products Agency (MPA) to conduct a Phase Ib/II clinical trial for Hemospan. The trial will be conducted at the Karolinska Hospital in Stockholm, Sweden and is anticipated to include thirty patients undergoing elective orthopedic surgeries. Sangart expects the trial will commence in January 2003.
Robert M. Winslow, M.D., Chairman and Chief Executive Officer of Sangart, commented, "We are pleased with the decision from the MPA allowing us to commence the next stage of clinical development for our Hemospan product for use as an alternative to traditional blood transfusions in orthopedic surgeries. We feel that this is an important step in the development of Hemospan and will allow us to highlight the clear clinical advantages of our product as a radical departure from other oxygen transport blood substitutes in terms of safety and efficacy."
About Hemospan
Hemospan is a product that is designed to serve as an alternative for red blood cell transfusions. Hemospan represents a revolutionary approach in oxygen transport technology and is distinct from blood substitute products that have languished in decades-old clinical research. Sangart's products are chemically modified hemoglobin solutions prepared from outdated human blood, designed specifically to maximize oxygen transport to tissues that need it most.
About Sangart
Sangart is a private biopharmaceutical company focused on the research, development and commercialization of medical products designed for use as alternatives to blood transfusions. The products are chemically modified hemoglobin solutions prepared from outdated human blood, designed specifically to transport oxygen in a cell-free solution.
Dr. Robert Winslow, a world-renowned authority in the field of oxygen transport, founded Sangart in 1998. In the two decades prior to founding Sangart, Dr. Winslow and his colleagues studied and defined mechanisms of oxygen transport by cell-free hemoglobin solutions, funded by competitive grants from the National Institutes of Health and the Department of Defense. The counterintuitive discoveries by Dr. Winslow's group on the effective action of oxygen transport agents have been patented and published in numerous scientific articles. From this experience, Sangart designed its lead product, Hemospan, using unique polyethylene glycol conjugation to create a hemoglobin-based product that is intended to serve as an alternative to donated blood.
The key breakthroughs in the development of Hemospan were the understanding of the mechanisms of vasoconstriction and the development of simplified production methods that make the final product commercially viable. These breakthroughs laid the groundwork for Sangart's business concept of developing cost-effective oxygen carriers that can be used in lieu of transfused red blood cells during episodes of temporary blood loss, such as surgery or trauma.
To learn more about Sangart or Hemospan®, please visit www.sangart.com
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Edelman
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Edelman
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