Sangart, Inc. Completes Enrollment in Phase IIa Study of Oxygen Therapeutic Agent MP4OX in Severe Trauma Patients
By Sangart Inc., PRNETuesday, June 29, 2010
SAN DIEGO, June 30, 2010 - Sangart, Inc., today announced that enrollment was completed in a Phase
IIa clinical study of MP4OX (oxygenated pegylated hemoglobin) in severely
injured trauma patients with hemorrhagic shock causing lactic acidosis.
Complete study results are expected, after follow up of outcomes in these
patients, in the second half of 2010.
"The hemorrhagic shock that results from severe trauma can cause organ
dysfunction and even death," said Karim Brohi, global principal investigator
of the study. "Pre-clinical study models of hemorrhagic shock suggest that
MP4OX has the potential to provide an improvement in patient outcomes above
that of current standard of care treatments."
The multi-center, randomized, double-blind, controlled clinical trial
enrolled 51 patients experiencing trauma-induced severe hemorrhagic shock at
12 clinical sites in the United Kingdom, France, Germany and South Africa to
investigate improved oxygenation of organs and tissues. 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. The primary objective of the study was to measure reduction in
lactate levels after infusion of MP4OX.
"We are pleased that the MP4OX study has completed enrollment on time and
within our enrollment target range," said Brian O'Callaghan, President and
Chief Executive Officer of Sangart. "The enrollment completion signifies a
key milestone for Sangart and brings us closer to delivering a potential new
treatment option for patients suffering an acute traumatic injury."
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 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 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: Marites Cristobal Edelman Public Relations Office: +1-323-202-1424 Marites.Cristobal@edelman.com Cell: +1-415-819-2214
Marites Cristobal of Edelman Public Relations, +1-323-202-1424, Cell, +1-415-819-2214, Marites.Cristobal at edelman.com, for Sangart, Inc.
Tags: california, France, Germany, June 30, San diego, Sangart Inc., United Kingdom