Oxygen Biotherapeutics Selects Duke Clinical Research Institute to Conduct Phase 3 Trial of Levosimendan
Phase 3 trials anticipated to begin in Q3 2014 and to be conducted at 50 major cardiac surgery centers in North America
MORRISVILLE, NC, December 11, 2013 – Oxygen Biotherapeutics, Inc., (NASDAQ: OXBT), a pharmaceutical company focused on developing drugs for the acute care market, today announced that it has selected Duke University's Duke Clinical Research Institute, (DCRI) to conduct the Phase 3 trial of the Company's newly acquired compound, levosimendan. DCRI is the world's largest academic clinical research organization, with substantial experience in conducting cardiac surgery trials. The DCRI will serve as the coordinating center and Drs. John H. Alexander and Rajendra Mehta as lead investigators for the Phase 3 trial.
Levosimendan is a calcium sensitizer developed for intravenous use in hospitalized patients with acutely decompensated heart failure. The treatment is currently approved in more than 50 countries for this indication. 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.
Oxygen Biotherapeutics recently acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland.
John Kelley, CEO for Oxygen Biotherapeutics and former co-founder of Phyxius Pharma commented on this agreement: "We are extremely pleased to have an organization with the skill and expertise in conducting clinical trials that DCRI possesses as our partner. They have been responsible for managing a number of major cardiac surgery trials in the last decade, so their knowledge of this area of medicine is invaluable to us. At Phyxius Pharma, we worked with DCRI for the past three years to develop the clinical program for levosimendan. They played a key role in designing the Phase 3 protocol that has been approved by the FDA under SPA."
According to the scientific literature, LCOS occurs in 5-10% of cardiac surgery patients, and is associated with a 10 – 15 fold increase in mortality. There is no drug currently approved for the prevention or treatment of LCOS. The Phase 3 clinical trial will study if levosimendan administered before and during surgery will reduce the incidence of LCOS and associated morbidity and mortality. 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%.
The Phase 3 trial will be conducted in approximately 50 major cardiac surgery centers in North America. The trial will enroll patients undergoing coronary artery bypass graphs (CABG) and/or mitral valve surgery who are at risk for developing LCOS. The trial will be a double blind, randomized, placebo controlled study seeking to enroll 760 patients. It is expected that enrollment will begin in the third quarter of 2014, and will take approximately 18 months to complete. More details on the specifics of the trial will be released shortly.
John H. Alexander, M.D., MHS, Director of Cardiovascular Research, Duke Clinical Research Institute said about today's announcement: "We are excited to be continuing our work on levosimendan and to move forward with the conduct of this innovative Phase 3 trial. The prevention of complications after high-risk cardiac surgery is clearly an area of unmet medical need. Our recent analysis of the work that has been published on levosimendan to date indicated a benefit to high-risk cardiac surgery patients at risk for developing LCOS. This next phase of research will be important to determine whether those results are verified in a large study. (Harrison et al. J Cardiothorac Vasc Anesth 2013;27:1224:32)"
About Oxygen Biotherapeutics
Oxygen Biotherapeutics, Inc. is developing medical products for the acute care market. The company recently acquired the North American rights to develop and commercialize 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 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.
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 finalization of definitive agreements with DCRI, matters beyond the company's control that could lead to delays in the clinical study, 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 September 17, 2013, 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.
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