MORRISVILLE, N.C. & CHESTER, N.J.--(EON: Enhanced Online News)--Phyxius Pharma, Inc. and Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT), today announced that researchers at the Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine, recently published findings of a meta-analysis of multiple clinical trials that evaluated the use of levosimendan in patients undergoing heart surgery. The study aggregated and analyzed results from 14 independent clinical trials with a total of 1,155 patients. The published results showed that levosimendan was associated with reduced mortality (death) and other adverse outcomes including heart attacks during and after operation in patients with reduced heart function undergoing heart surgery. This research was recently published in the Journal of Cardiothoracic and Vascular Anesthesia as an "in Press" online version of the publication that precedes the final publication. A link to the online version of the publication is available here: http://www.jcvaonline.com/article/S1053-0770(13)00171-7/abstract.
“LCOS represents an area of unmet medical need. The results of this meta-analysis are highly supportive of Phyxius Pharma’s current Phase 3 clinical trial design that intends to evaluate the ability of levosimendan treatment to prevent LCOS and the associated mortality and morbidity.”
Oxygen Biotherapeutics has a Definitive Agreement to acquire certain assets of Phyxius Pharma, including the U.S. and Canadian development and commercialization rights to levosimendan. 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 Phyxius Pharma’s 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.
John Alexander, M.D., MHS, Director, Cardiovascular Research, Duke Clinical Research Institute said, “Our meta-analysis of 14 randomized clinical trials suggests that levosimendan, in conjunction with standard care in high-risk cardiac surgery patients with reduced left ventricular function, may reduce mortality and other adverse outcomes by as much as 50 percent.”
John Kelley, CEO of Phyxius Pharma stated, "These findings are highly supportive of our definitive Phase 3 trial design which includes mortality, need for dialysis, peri-operative myocardial infarction, as components of the primary composite endpoint. With the support of these data and the FDA’s guidance we have designed a very modest sized and highly cost efficient trial of 760 patients. This is far smaller than other cardiac trials which typically require larger patient populations.”
Robert Harrington, M.D. Chairman of the Department of Medicine at Stanford University stated, “LCOS represents an area of unmet medical need. The results of this meta-analysis are highly supportive of Phyxius Pharma’s current Phase 3 clinical trial design that intends to evaluate the ability of levosimendan treatment to prevent LCOS and the associated mortality and morbidity.”
Consistent with the positive meta-analysis findings, the Phase 3 trial is designed to include low EF (Ejection Fraction) cardiac surgery patients and evaluates several end points included in the meta-analysis.
About Phyxius Pharma
Phyxius Pharma, Inc. is a privately-held development stage pharmaceutical company. The company is focused on developing products for use in acute care settings. The company has licensed North American rights to develop and commercialize levosimendan from Orion Pharma, Orion Corporation of Espoo, Finland.
Levosimendan is a calcium sensitizer developed for intra-venous use in hospitalized patients with acutely decompensated heart failure. It is currently approved in 53 countries for this indication. It is not available in the United States. It is under development in North America for reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome (LCOS).
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. 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.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, the likelihood of the consummation of the Phyxius transaction, as well as the successful integration of Phyxius into the Company, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in our filings with the Securities and Exchange Commission, including in the current Form 10-Q filed on September 17, 2013, and our annual report on Form 10-K filed on June 26, 2013, as well as other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.