Oxygen Biotherapeutics is a specialty pharmaceutical company focused on the development and commercialization of products for critical care patients
Currently, we have two product candidates. Levosimendan is being developed for use in cardiac surgery patients at risk of Low Cardiac Output Syndrome (LCOS). Oxycyte PFC emulsion, is being developed to treat patients with traumatic brain injury (TBI). more...
Oxygen Biotherapeutics’ clinical development is supported by significant preclinical and clinical research. more...
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..
Product Pipeline Development
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. Learn more...
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. Learn more...