Oxygen Biotherapeutics Inc. Provides an Update on Communication with the FDA Regarding Oxycyte Development Program
Tuesday, March 4, 2014 5:00 am PST
Public Company Information:
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 been notified by the U.S. Food and Drug Administration (the “FDA”) that the agency has completed its review of the September 2013 nonclinical submission and has lifted the clinical hold on Oxycyte®. Lifting of the clinical hold clears the company to proceed with the clinical development program in the US. The FDA communicated this information to the company during a conference call with the FDA on Friday, February 28, 2014. Written confirmation of the FDA’s decision is expected to be received within 30 days. more..
Currently, we have two product candidates in clinical development. Levosimendan (Phase 3) is being developed for use in cardiac surgery patients at risk of Low Cardiac Output Syndrome (LCOS). Oxycyte PFC emulsion (Phase 2), is being developed to treat patients with traumatic brain injury (TBI).
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 agreed to 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.