SAN DIEGO, Dec. 9 Sangart, Inc., 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, today announced the initiation of a dose-finding study designed to evaluate the safety and efficacy of MP4OX treatment plus standard of care in severely injured trauma patients with lactic acidosis due to hemorrhagic shock. MP4OX is a novel oxygen therapeutic agent that is designed to provide rapid oxygen delivery to ischemic tissues.
"Pre-clinical studies suggest that MP4OX has the potential to improve outcomes after major trauma. When a lot of blood has been lost and patients are in shock, MP4OX may increase the delivery of oxygen to the body and therefore prevent organs from failing," said Karim Brohi, Professor of Trauma Sciences at Barts and the London School of Medicine & Dentistry and lead study investigator. "The initiation of this clinical trial is an important step in finding a treatment that can improve patient outcomes after major trauma."
The clinical trial will be a multi-center, randomized, double-blind, controlled study that will enroll up to 75 patients who have suffered hemorrhagic shock with lactic acidosis across approximately 12 trial sites in Europe and South Africa. The primary objective of the study is to measure reduction in lactate levels after infusion of MP4OX. Acute traumatic injury, including both blunt and penetrating trauma is often associated with severe bleeding which can lead to hemorrhagic shock. During shock, inadequate perfusion of critical organs can lead to insufficient oxygenation of tissues, which can be detected by an increase in lactate levels.
"The initiation of this study is another key milestone for Sangart as we continue to develop medicines designed to enhance the delivery of oxygen to tissues and organs that are oxygen deprived, particularly in patients who experience an acute traumatic injury," said Brian O'Callaghan, President and Chief Executive Officer of Sangart. "MP4OX is an integral part of our platform of products designed to help patients with medical conditions that deprive tissue of necessary oxygen."
Physical trauma is a serious injury to the body. According to the Centers for Disease Control and Prevention (CDC), unintentional injury kills more people between the ages of one and 44 than any other disease or illness.
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.
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.
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.
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SOURCE Sangart, Inc.