SAN DIEGO, June 11 CA-Sangart-Hemospan
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.
