Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that it has completed patient enrollment for its Phase 3 LEVO-CTS trial in cardiac surgery.
The Company will lock its database after 30-day follow-up from the final patient, and currently expects to report top-line results in January 2017 in conjunction with the study’s lead investigators at Duke Clinical Research Institute (DCRI).
“We are very pleased to reach this milestone after more than two years of hard work, and would like to thank all of the patients and investigators who have taken part in the trial,” said John Kelley, CEO of Tenax Therapeutics. “Consistent clinical execution and increased trial visibility has significantly accelerated the enrollment rate during these past 12 months, and we believe the expanded number of patients ensures that we have the best possible chance for success. We now look forward to sharing top-line results with you during the next few months, and we are prepared for a near-term NDA submission and commercial effort if the data reads out positively. We continue to believe that levosimendan has the potential to fill an important void in the current treatment paradigm for cardiac surgery.”
The trial has enrolled a total of 880 patients. This was larger than the original target enrollment number of 760 patients in order to ensure sufficient powering – which was necessary due to a small number of patients who were randomized but did not receive study drug, a small number of patients missing one or more component measurements of the primary endpoint, and a slightly lower primary endpoint event rate than originally projected.
The LEVO-CTS trial is a double-blind, randomized, placebo-controlled study that is evaluating the use of levosimendan administered before and during cardiac surgery to reduce the incidence of low cardiac output syndrome (LCOS) and associated morbidity and mortality. The trial is also measuring secondary endpoints around potential pharmacoeconomic benefits and the incidence rate of LCOS. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan in this indication, and agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA).
The full LEVO-CTS trial design was recently published by the study’s investigators in the American Heart Journal in an article titled, “Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery on Cardiopulmonary Bypass: Rationale and Study Design of the LEVO-CTS Trial.”
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 acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing and commercializing 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 is currently in a Phase 3 trial with levosimendan for that indication. 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 transition report on Form 10-KT filed on March 14, 2016, its quarterly report on Form 10-Q filed on November 9, 2016 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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Will O‘Connor, 212-362-1200