News & Events
Oxygen Biotherapeutics Inc., Announces the Appointment of Industry Veteran Gerald Proehl to its Board of Directors
Friday, April 4, 2014 5:00 am PDT
Public Company Information:
MORRISVILLE, N.C.--(BUSINESS WIRE)--Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, announced today that it has appointed Gerald Proehl, former President and CEO of Santarus, Inc. as a member of the company’s Board of Directors. Mr. Proehl’s addition is a new position on the company’s Board. more..
Levosimendan- Phase 3
Levosimendan is under development in North America for reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome (LCOS). The FDA has granted Fast Track status for levosimendan and has agreed to our Phase 3 clinical trial protocol under a Special Protocol Assessment (SPA). The FDA has provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication.
The Phase 3 clinical trial will study if levosimendan administered before and during surgery will reduce the incidence of morbidity and mortality in cardiac surgery patients at risk. There is substantial scientific evidence for the use of levosimendan in cardiovascular surgery, with over 25 published articles in peer reviewed journals and evidence of mortality reduction in some cardiac surgery trials of more than 50%.
Oxycyte® – Phase 2
The ongoing clinical trial in traumatic brain injury (TBI) is a double-blind, placebo–controlled, dose-escalation study. The first cohort of patients has been successfully completed in Israel and Switzerland with an independent data safety monitoring board approving advancement to the next higher dose. Enrollment in the second cohort, which began in May 2013, is progressing and we have recently made submissions to regulatory authorities to expand the trial into more European countries.
Phase 1 and 2a clinical development studies were conducted in the United States; however, the current trial is on clinical hold in the US due to FDA concerns regarding class effects (e.g., thrombocytopenia and immunosuppression) of earlier perfluorocarbon-based emulsion products. In 2011, we received a $2.07 million cost reimbursement award from the U.S. Army to conduct safety related preclinical studies for Oxycyte PFC emulsion that will enable us to address the agency’s questions.