Sangart Initiates Phase 2b Study of Oxygen Therapeutic Agent MP4OX in Severe Trauma Patients With Hemorrhagic Shock
SAN DIEGO, June 14, 2011 /PRNewswire/ -- 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 and other gas delivery, today announced the initiation of a Phase 2b study designed to evaluate the efficacy and safety 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.
"Based on results from the preclinical and Phase 2a studies, MP4OX has shown its potential in improving outcomes in bleeding trauma patients," said Karim Brohi, Professor of Trauma Sciences at the Royal London Hospital. "These studies have shown that MP4OX may increase the delivery of oxygen to the body and prevent organs from failing when a patient is experiencing hemorrhagic shock. This trial initiation is a key phase in finding a treatment that can improve patient outcomes after major trauma."
The clinical trial is a multi-center, randomized, double-blind, controlled study that will enroll approximately 360 patients who have suffered hemorrhagic shock with lactic acidosis across approximately 50 trial sites in 15 countries. The primary objective of the study is to measure the proportion of patients discharged alive from the hospital, as well as a number of secondary endpoints including lactic acidosis resolution. The dosing regimen in this study will include an initial dose of 250 mL of MP4OX plus up to three replacement doses of 250 mL each, all within 12 hours following the initial dose.
"The initiation of this study is another important step in bringing MP4OX to patients with medical conditions that deprive tissue of necessary oxygen," said Brian O'Callaghan, President and CEO of Sangart. "We remain committed to developing 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."
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, despite resuscitation, and can be detected by an increase in lactate levels.
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.
Marites Cristobal Coulter
Edelman Public Relations
SOURCE Sangart, Inc.