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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