Sangart completes enrollment for MP4OX Phase IIa study in severely injured trauma patients

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."