Sangart, Inc., 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.
Source: Sangart