Tenax Therapeutics Announces New Scientific Publication of Preclinical Data Provides Additional Evidence of Levosimendan Treatment Effects in Pulmonary Hypertension

MORRISVILLE, N.C.--(BUSINESS WIRE)-- Tenax Therapeutics, Inc. (Nasdaq: TENX) today announced the publication of a positive preclinical study of levosimendan conducted by Hansen et al in the March 1, 2018, issue of Pulmonary Circulation. The study was titled “Levosimendan improves cardiac function and myocardial efficiency in rats with right ventricular failure” and found that chronic administration of levosimendan improved right heart function. Dr. Hansen and colleagues assessed the effects of levosimendan in an experimental model of right heart failure. The authors conclude the study results support the “potential therapeutic value of chronic levosimendan in treatment RV failure.”

This is the second study published in recent months by Dr. Hansen and colleagues who have investigated the potential benefits of levosimendan treatment for right heart failure secondary to pulmonary hypertension. This group published similar findings in October 2017 in Journal of Cardiovascular Pharmacology in a study titled, “Levosimendan Prevents and Reverts Right Ventricular Failure in Experimental Pulmonary Arterial Hypertension.” The results from this preclinical study resulted in the authors concluding that “Chronic treatment with levosimendan prevents and reverts the development of RV failure and attenuates pulmonary vascular remodeling in a rat model of PAH.”

Observations from these preclinical studies are in keeping with previous clinical trials of levosimendan in pulmonary hypertension patients conducted by Kleber et al in 2009 and Jiang et al in 2017. Each provided evidence that levosimendan may provide benefits to patients with pulmonary hypertension, including those with coexisting right heart failure.

Michael Jebsen, Interim CEO of Tenax Therapeutics stated, “The promising findings reported in the scientific literature provide additional support to our hypothesis that levosimendan has the potential to offer significant benefits in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) patients through improvements in right heart function. We believe that levosimendan’s unique mechanisms of action will provide an alternative therapy for PH-HFpEF patients who currently have no effective or approved therapies to help manage their disease. Our Phase 2 study for this indication is anticipated to begin in the later part of next quarter.”

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 60 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, Inc.

Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on licensing, development, and commercialization of drugs that address conditions with high unmet medical need. The Company has a world-class scientific team including recognized global experts in pulmonary hypertension. The Company owns the North American rights to develop and commercialize levosimendan. For more information, visit www.tenaxthera.com.

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 annual report on Form 10-K filed on March 16, 2017, its quarterly report on Form 10-Q filed on November 9, 2017 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.