Sangart, Inc. Completes Patient Enrollment in Phase 2B Clinical Trial of MP4OX in Traumatic Hemorrhagic Shock Patients
Published: Oct 09, 2012
SAN DIEGO, Oct. 8, 2012 /PRNewswire/ -- Sangart, Inc., a global biopharmaceutical company dedicated to developing rescue therapies for patients in ischemic crisis, today announced the completion of patient enrollment in its Phase 2b study designed to evaluate the efficacy and safety of MP4OX treatment in severely injured trauma patients experiencing hemorrhagic shock. MP4OX is a novel ischemic rescue therapy designed to improve perfusion and oxygen delivery to tissues.
"This achievement is a tribute to the excellent execution and diligent follow-up by the investigative sites and our clinical operations team," said Brian O'Callaghan, President and CEO of Sangart. "As past experience has shown, the conduct of trauma trials can be extraordinarily difficult and achieving this milestone is a major achievement of which all participants can justly be proud."
The clinical trial was a multi-center, randomized, double-blind, controlled study that enrolled patients suffering from hemorrhagic shock with lactic acidosis at 53 trial sites in 15 countries. The primary endpoint of the study is the proportion of patients able to be discharged alive from the hospital within 28 days following the trauma.
Trauma is the leading cause of death in people under the age of 44 leading to over 5 million deaths annually worldwide. In the US, trauma accounts for 42 million emergency department visits and 2 million hospital admissions every year. 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, represents metabolic failure which may lead to cardiovascular, renal and hepatic dysfunction. Prolonged lactic acidosis correlates with worse outcomes and higher mortality.
Sangart's unique MP4 gas-delivery platform is being used to develop therapies for patients in crisis who are experiencing ischemia (oxygen deprivation of tissues) and organ dysfunction as a result of hemorrhagic shock injury or a vaso-occlusive crisis associated with sickle cell disease.
Sangart is a global biopharmaceutical company dedicated to developing and commercializing targeted rescue therapies for patients in acute ischemic crisis. Sangart's therapies are designed to help patients with medical conditions that cause ischemia, such as hemorrhagic shock and sickle cell disease.
To learn more about Sangart, please visit the company's website at www.sangart.com.
Edelman Public Relations
SOURCE Sangart, Inc.