Sangart, Inc. Reports Positive Phase IIa Data for Novel Oxygen Therapeutic Agent MP4OX in Severe Trauma Patients
Study meets primary endpoint of reducing lactate levels in trauma patients treated with MP4OX
SAN DIEGO, Aug. 31 /PRNewswire/ -- Sangart, Inc., today
announced positive results from its Phase IIa proof-of-concept
study of MP4OX (oxygenated pegylated hemoglobin) in severely
injured trauma patients with hemorrhagic shock causing lactic
acidosis. The study demonstrated that MP4OX, when given in addition
to standard of care, was effective at decreasing lactate levels in
treated patients. During hemorrhagic shock, inadequate perfusion of
critical organs can lead to insufficient oxygenation of tissues,
which can be detected by an increase in lactate levels. MP4OX is a
novel oxygen therapeutic agent that is designed to provide rapid
oxygen delivery to ischemic tissues.
Study data show a statistically significant greater immediate
and sustained decrease of lactic acid in patients treated with
MP4OX compared to patients in the control group. The study also
found that a greater proportion of patients treated with MP4OX were
able to attain normal lactate levels as early as four hours
post-treatment. Furthermore, data demonstrated a strong trend
toward outcomes benefits through multiple measures, including
reducing the average total number of days patients spent in
hospital. In patients treated with MP4OX, the median hospital stay
was half that of the control group. Serious adverse events were of
equal rates and similar in nature between the MP4OX-treated and
control groups.
"Trauma patients suffer organ dysfunction from shock and lack of
oxygen supply to vital tissues. Prolonged lactic acidosis, a marker
of shock, correlates with a worse outcome and higher mortality
rate. This study suggests that MP4OX has the ability to improve
oxygen delivery to the body and subsequently reduce organ failure
and other complications," said Karim Brohi, Professor of Trauma
Sciences at Barts and the London School of Medicine & Dentistry
and lead study investigator. "We are excited by the results from
this study as they suggest that MP4OX has the potential to improve
patient outcomes compared to the current standard of care in
trauma."
The clinical trial was a multi-center, randomized, double-blind,
controlled study that enrolled 51 patients who suffered
trauma-induced severe hemorrhagic shock across 11 clinical sites in
the United Kingdom, Germany, France and South Africa. The primary
objective of the study was to measure reduction in lactate levels
after infusion of MP4OX.
"The positive safety and efficacy data from this trial suggest
that MP4OX could be a promising new treatment option for patients
suffering an acute traumatic injury," said Brian O'Callaghan,
President and Chief Executive Officer of Sangart. "Based on these
results, we plan to further development and clinical evaluation of
MP4OX and initiate Phase IIb clinical studies in trauma patients.
This study further reinforces the promise of our MP4 platform in
the development of medicines designed to enhance the delivery of
oxygen to tissues and organs that are oxygen deprived."
About Trauma
Traumatic injuries, including both penetrating trauma injuries
such as bullet and knife wounds and blunt trauma from car accidents
and falls, cause the death of over 5 million people each year
world-wide. Trauma is the leading cause of death in people under
the age of 44. Despite optimal care, many patients treated for
traumatic injuries suffer organ dysfunction and failure. Elevated
lactate levels (lactic acidosis), which indicate hypoperfusion and
anaerobic metabolism (oxygen deprivation) in tissues and organs in
the body, represent metabolic failure and also cardiovascular,
renal and hepatic dysfunction. Prolonged lactic acidosis correlates
with worse outcomes and higher mortality.
About MP4
Sangart's product platform is based on the MP4 molecule, an
investigational biopharmaceutical product designed to enhance the
perfusion of oxygen-deprived (ischemic) tissues and provide
targeted oxygen delivery in the capillaries. Using a novel
pegylation approach, Sangart produces the MP4 molecule designed at
the optimal oxygen affinity, diffusion potential and molecular size
to perfuse capillaries and target oxygen delivery to tissues
specifically at risk of ischemia.
About Sangart
Sangart is a global biopharmaceutical company dedicated to
developing life-saving medicines specifically designed to enhance
the perfusion and oxygenation of ischemic (oxygen deprived) tissues
through targeted oxygen delivery. Based on more than a decade of
research, Sangart has refined the pegylation of human hemoglobin to
create a molecule, MP4, with the ability to carry oxygen through
the circulatory system to prevent and treat ischemia.
To learn more about Sangart, please visit the company's website
at www.sangart.com.
Media Contact: Lauren Hamilton Edelman Public Relations Office: 323-202-1425 Lauren.Hamilton@edelman.com
Source: Sangart, Inc.
CONTACT: Lauren Hamilton of Edelman Public Relations,
+1-323-202-1425,
Lauren.Hamilton@edelman.com
for Sangart
Web Site: http://www.sangart.com/
Posted: August 2010
