August 31, 2010
Sangart Reports Positive Phase IIa Data For Novel Oxygen Therapeutic Agent MP4OX In Trauma Patients
Study meets primary endpoint of reducing lactate levels in trauma patients treated with MP4OX
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."
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