“Oxygen Biotherapeutics, Inc has made tremendous progress in 2013” said John Kelley, CEO. “The acquisition of the Phyxius Pharma assets was a transformative deal for this company. We now have the opportunity to build a company with a portfolio of assets focused on the critical care market. We look forward to an exciting 2014 with significant accomplishments ahead. On December 11, 2013 Oxygen Biotherapeutics announced that it had selected Duke University’s Duke Clinical Research Institute, (DCRI) to conduct the Phase 3 trial of the levosimendan. The Phase 3 trial will be conducted in approximately 50 major cardiac surgery centers in North America. It was earlier announced that researchers at the DCRI recently published findings with The earlier study. The published results showed that levosimendan was associated with reduced mortality and other adverse outcomes including heart attacks during and after operation in patients with reduced heart function undergoing heart surgery. FAST TRACK!!!They don’t fast track just anything………. !!! The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). In addition, the FDA has agreed to a Phase 3 protocol design under Special Protocol Assessment (SPA), and provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication. The company also has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte® that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke. It is currently approved in over 50 countries for this indication and not available in the United States. The FDA has provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication. It is expected that enrollment will begin in the third quarter of 2014, and will take approximately 18 months to complete. Anticipated 2014 Milestones
• Enroll first patient in the Phase 3 trial for levosimendan in cardiac surgery patients at risk for developing LCOS in July 2014.
• Completion of Army-funded preclinical safety studies for Oxycyte in the 2nd quarter of 2014.
• Completion of the second cohort of patient enrollment in the phase II-b clinical trial for traumatic brain injury (TBI) in the 3rd quarter of 2014.
Nov 5, 2013) - Oxygen Biotherapeutics, Inc. (NASDAQ: OXBT) is developing medical products that efficiently deliver oxygen to tissues in the body. The company has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte® that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke. @@@@ The company is also developing PFC-based creams and gels for topical delivery to the skin for dermatologic conditions and potentially wound care.
The MM like to play games a lot.... Very Very soon... If you look at QCOR and what the MM did with that one.... It was all over the place and roared. This one roared and gave back some, but the roar is still to come with more positive things. Forbes does not put articles for nothing and also this company does have a future.