Skip to content

newsroom

Newsroom

Newsroom

Data Safety Monitoring Board Recommends Continuation of Sangart's Phase IIa Trial for Oxygen Therapeutic MP4OX in Severe Trauma Patients - Clinical Trial Enrollment Remains on Track

SAN DIEGO, CA (April 22, 2010) 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 that an independent data safety monitoring board (DSMB) reviewed clinical data for 21 patients enrolled in the Phase IIa clinical trial for its oxygen therapeutic MP4OX in severe trauma patients with hemorrhagic shock and unanimously recommended that the study be continued without modification.

The DSMB is an independent group of medical experts enlisted by Sangart to review and evaluate the interim safety data generated from the Company's Phase IIa study of MP4OX in order to make recommendations regarding the continuation, modification or termination of the study due to safety concerns. This DSMB recommendation was based on a pre-planned interim analysis of the study data. Study enrollment will continue over the next few months, and final data from the study are expected to be available in late 2010. "We are pleased that after its initial review, the DSMB has recommended continuation of the Phase IIa study, which reinforces the potential and safety of oxygen therapeutics such as MP4OX," said Brian O'Callaghan, President and Chief Executive Officer of Sangart. "Enrollment in the trial is progressing well, and we are excited by the progress seen in this study. We look forward to being able to continue exploring the use of MP4OX in trauma and helping improve patient outcomes for major traumatic injury." The Phase IIa clinical trial is a multi-center, randomized, double-blind, controlled study that will enroll up to 75 patients who have suffered hemorrhagic shock with lactic acidosis across 14 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.

About Trauma

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.

About Sangart

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.

Media Contact:
Marites Cristobal
Edelman Public Relations
Marites.Cristobal@edelman.com
Cell: 415-819-2214
Office: 323-202-1424

FOR PRESS INQUIRIES

Contact:
Rachel Martin
Edelman Public Relations
(323) 202-1031
Rachel.Martin@edelman.com