Tenax Therapeutics Announces First Patients Enrolled in Phase 3 LEVO-CTS Clinical Trial of Levosimendan
Tenax Therapeutics, Inc. (NASDAQ:TENX) , formerly Oxygen Biotherapeutics, Inc., a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced that the first patients have been enrolled in the LEVO-CTS Phase 3 trial designed to assess the benefits of levosimendan in cardiac surgery patients at risk of developing low cardiac output syndrome (LCOS).
“We are pleased to begin this important Phase 3 study, which has been designed in consultation with leading cardiovascular experts and investigators to provide a clear answer on the potential of levosimendan to prevent complications after high-risk cardiac surgery,” said John Kelley, CEO of Tenax Therapeutics. “We look forward to working with our colleagues at Duke Clinical Research Institute and the other cardiac surgery centers and hospitals involved in the trial, as we continue to activate many additional clinical sites in the months ahead.”
LEVO-CTS is a multi-center, double blind, randomized, placebo-controlled clinical trial that is testing the hypothesis that levosimendan reduces morbidity and mortality in cardiac surgery patients at risk for developing (LCOS). The U.S. Food and Drug Administration (FDA) has already granted Fast Track status for levosimendan in this LCOS indication, and agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA) with guidance that this single successful trial will be sufficient to support approval.
“The LEVO-CTS trial design will test levosimendan in the prevention of LCOS in high-risk patients undergoing cardiac surgery – an area of high unmet medical need and one where several smaller published clinical trials have suggested potential benefit,” said lead investigator John H. Alexander, M.D., MHS, Director of Cardiovascular Research, Duke Clinical Research Institute (DCRI). “We are pleased to be getting started with enrollment and are projected to have results in early 2016.”
The LEVO-CTS trial is being led by DCRI and will take place at approximately 50 major cardiac surgery centers in North America. It is seeking to enroll 760 patients undergoing coronary artery bypass graft surgery or mitral valve surgery that are at risk for developing LCOS.
The trial is event-driven, and includes a review of the event rate after the first 200 patients have been randomized in the trial. Two interim analyses will test for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded.
The full protocol for this trial has been published on ClinicalTrials.gov (NCT02025621).
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was 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. Tenax Therapeutics 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 Tenax Therapeutics
Tenax Therapeutics, Inc. (formerly Oxygen Biotherapeutics) is a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market. The company owns 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 initiated a Phase 3 trial with levosimendan in that indication in July 2014. For more information, visit www.tenaxthera.com.
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 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 15, 2014 and annual report on Form 10-K filed on July 29, 2014, 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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