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Oxygen Biotherapeutics Announces Formation of Steering Committee for Phase 3 LEVO-CTS Trial of Levosimendan

June 2, 2014

- John H. Alexander, M.D., M.H.S, Head of Cardiovascular Research at Duke Clinical Research Institute, to serve as committee chair -

- Trial to start in third quarter of 2014 -

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, today announced the formation of a steering committee for the Company’s Phase 3 LEVO-CTS trial to evaluate levosimendan in cardiac surgery patients at risk of developing low cardiac output syndrome (LCOS). The committee includes experts in the fields of cardiology, cardiac surgery, cardiac anesthesia and clinical trials.

John H. Alexander, M.D., M.H.S, Director of Cardiovascular Research, Duke Clinical Research Institute (DCRI) will serve as the Committee Chair. At the DCRI, Dr. Alexander oversees a broad portfolio of clinical trials and has led a number of important studies in cardiology and cardiac surgery.

“We are very pleased to announce this Steering Committee to provide academic leadership for our upcoming Phase 3 LEVO-CTS trial, which includes leading cardiovascular investigators and has already provided crucial guidance for the trial design as we prepare to enroll our first patient in the third quarter of this year,” said John Kelley, CEO of Oxygen Biotherapeutics. “Levosimendan provides a unique opportunity to test a drug candidate with an established clinical profile in an area of clear unmet medical need – the prevention of complications after high-risk cardiac surgery. Data to date suggests that levosimendan can provide a benefit for these patients at risk of developing LCOS, and we look forward to working with the steering committee to try and verify those results in a larger study and bring this therapeutic option to patients in North America.”

“I am excited to work with my DCRI colleague and fellow lead investigator Raj Mehta, M.D., and this outstanding group of collaborators on this important trial,” Dr. Alexander said. “We, together with the teams at DCRI and Oxygen Biotherapeutics, look forward to enrolling the first patients later this year and providing a definitive answer about the role of levosimendan in high-risk patients undergoing cardiac surgery through the results of the LEVO-CTS study.”

Additional members of the steering committee are:

  • Robert Harrington, MD, Arthur L. Bloomfield Professor of Medicine; Chair, Department of Medicine, Stanford University
  • John Luber, M.D., Cardiac Surgeon, Franciscan Cardiothoracic Surgery Associates at St. Joseph
  • Wolfgang Toller, M.D., Head of Department of Anesthesiology and Intensive Care Medicine, University of Graz, Austria
  • Matthias Heringlake, M.D., Professor of Anesthesiology, University of LÜbeck
  • Jerrold H. Levy, MD, FCCM, Professor of Anesthesiology, Duke University School of Medicine
  • Kevin Anstrom, Ph.D., Associate Professor of Biostatistics and Bioinformatics, Duke University School of Medicine

    About Levosimendan

    Levosimendan is a calcium sensitizer developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 50 countries for this indication and not available in the United States. Oxygen Biotherapeutics recently acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma. 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 the 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.

    About Phase 3 LEVO-CTS Clinical Trial

    The Phase 3 LEVO-CTS trial is a double-blind, randomized, placebo-controlled study that will evaluate if levosimendan administered before and during cardiac surgery can reduce the incidence of LCOS and associated morbidity and mortality. The trial is seeking to enroll 760 patients undergoing coronary artery bypass grafts (CABG) and/or mitral valve surgery that are at risk for developing LCOS.

    Duke University’s Duke Clinical Research Institute (DCRI) will conduct the Phase 3 trial, which will take place in approximately 50 major cardiac surgery centers in North America. The trial is event-driven, and protocol includes a review of the control arm event rate for the first 200 patients randomized in the trial. The study population can be enriched to a higher percentage of patients with a greater degree of left ventricular dysfunction to increase the control event rate. Two interim analyses will test for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded.

    The protocol for this trial has been published on ClinicalTrials.gov.

    About Oxygen Biotherapeutics

    Oxygen Biotherapeutics, Inc. is a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market. The company recently acquired the North American rights to develop and commercialize levosimendan, and 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). The company plans to start a Phase 3 trial with levosimendan in that indication during the third quarter of 2014, and has also 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.

    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 matters beyond the company's control that could lead to delays in the clinical studies, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in the company’s filings with the Securities and Exchange Commission, including in its quarterly report on Form 10-Q filed on March 17, 2014, and annual report on Form 10-K filed on June 26, 2013, as well as its other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.




    Stern Investor Relations

    Jesse Baumgartner, 212-362-1200

    jesse@sternir.com

    Source: Oxygen Biotherapeutics, Inc.


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