Sangart Responds to Report Published in the Journal of the American Medical Association and Provides Update on Phase III Trials of Hemospan(R)

    SAN DIEGO, June 11 /PRNewswire/ -- Sangart, Inc., a privately held
 biopharmaceutical company focused on the research, development and
 commercialization of oxygen transport agents, today issued the following
 statement in response to a report in the May 21st edition of the Journal of
 the American Medical Association (JAMA) linking hemoglobin based oxygen
 carriers (HBOCs) to safety issues.
 
     "Those who have followed the development of hemoglobin-based oxygen
 carriers have long known of safety issues associated with many of the
 earlier generation HBOC products developed prior to Hemospan," said Dr.
 Robert Winslow, Sangart's chairman. "Hemospan was specifically designed,
 after decades of careful thought and research, to have novel chemical
 properties and a distinct oxygen delivery mechanism and thereby avoid the
 safety issues common to many earlier-generation products. We believe
 Sangart's preclinical and clinical data generated thus far vindicate our
 approach, reinforcing the promise that Hemospan will prove to be a safe and
 effective oxygen transport agent."
 
     Following the publication of the JAMA article and the accompanying
 editorial, a number of inaccurate reports have appeared in the press
 regarding Hemospan and its safety profile.
 
     The JAMA article described a statistical meta-analysis examining the
 incidence of myocardial infarction and death as reported in the published
 clinical trial data from five different HBOCs, including Hemospan. The four
 other HBOCs included in the metaanalysis were all earlier-generation
 products developed well before Hemospan, and have materially different
 chemical structures and oxygen transport properties. The only Hemospan data
 included in the meta-analysis constituted a very small fraction
 (approximately 2%) of the overall data analyzed and therefore had virtually
 no bearing on the overall statistical outcome of the meta-analysis. The
 Hemospan data cited in the meta-analysis was also misreported: the stated
 number of patients involved in the Phase II study is inaccurate, and
 relevant data from another published Phase II study report was completely
 excluded.
 
     For these reasons, Sangart does not believe that the meta-analysis
 described in the JAMA article should be perceived as representing a valid
 evaluation of Hemospan, its properties, or its safety profile.
 
     Dr. Winslow commented, "We believe an accurate safety profile of
 Hemospan will be reflected when all its clinical study data is analyzed,
 and we look forward to publishing the Phase III clinical trial results as
 soon as they become available." Sangart expects to report top-line results
 from these studies later this year.
 
     Sangart recently completed patient enrollment in two randomized,
 double-blind multicenter Phase III clinical trials of Hemospan in patients
 undergoing elective hip arthroplasty. Both trials were fully completed
 according to protocol and together enrolled more than 830 patients in six
 European countries including Belgium, the Czech Republic, the Netherlands,
 Poland, Sweden and the United Kingdom. Data from those studies is currently
 being compiled and has not yet been unblinded, though two earlier reviews
 of the blinded interim safety data by an independent Data Safety Monitoring
 Board found nothing to indicate that the Phase III trials should not be
 permitted to continue as planned.
 
     Before finalizing the design and clinical endpoints for the Phase III
 program, Sangart sought scientific advice from national regulatory
 authorities in Sweden and the United Kingdom, and also obtained formal
 scientific advice from the European Medicines Agency (EMEA). The resulting
 two Phase III study protocols were then submitted for review and approval
 by the regulatory authorities in each of the six countries where these
 studies were conducted. Each of the agencies reviewed the preclinical
 safety data and the earlier clinical data from a Phase I and two Phase II
 trials of Hemospan submitted to support initiation of the two pivotal Phase
 III studies. Results from the three completed clinical studies have been
 published in peer-reviewed scientific journals.
 
     "Hemospan is fundamentally different from earlier generation products,"
 commented Dr. Winslow. "Sangart's Phase III trials have been designed to
 demonstrate that Hemospan is not associated with the adverse side effects
 typically reported in many of the clinical trials with earlier generation
 HBOC solutions."
 
     About Sangart
 
     Sangart is a privately held San Diego-based biopharmaceutical company
 focused on the research, development and commercialization of medical
 products designed for use as therapeutic oxygen transport agents and
 potential alternatives to blood transfusions.
 
     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's
 lead product, Hemospan, was designed using unique polyethylene glycol
 conjugation to create a hemoglobin-based product that is intended to serve
 as an alternative to transfusion of donor 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 are designed to make the final product
 commercially viable. These breakthroughs laid the groundwork for Sangart's
 business concept of developing cost-effective oxygen transport agents 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, please visit the company's website at
 www.sangart.com.
 
 
 

SOURCE Sangart, Inc.

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