Tenax Therapeutics Activates First Clinical Research Site for Phase 2 Pulmonary Hypertension Clinical Trial
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that Stanford University School of Medicine has been activated as the first clinical research site for the Company’s Phase 2 trial designed to evaluate levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the H-E-L-P Trial (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF) and is expected to enroll a total of 36 PH-HFpEF patients at up to approximately 12-15 major research institutions across the US.
Anthony DiTonno, CEO of Tenax Therapeutics, Inc., stated, “We are very excited to have activated our first site for the HELP trial. We are equally excited that so many highly regarded medical centers and principal investigators have indicated strong interest in participating in the trial and we expect to have several additional site activations in the coming weeks.”
The HELP trial is designed to evaluate the hemodynamic benefits of levosimendan, compared to placebo in patients with PH-HFpEF. In addition to the previously conducted preclinical and clinical studies, the trial design has been informed by the substantial clinical experience that comes from more than one million patients who have been treated in over 60 countries where levosimendan is currently approved to treat acute heart failure.
PH-HFpEF represents an area of very high unmet medical need. No approved or effective therapies currently exist to treat the many patients who suffer with PH-HFpEF. Preliminary data from preclinical and clinical studies of pulmonary hypertension and heart failure patients provide a reason to believe that levosimendan may provide important benefits for PH-HFpEF patients.
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 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 and is finalizing preparations to begin their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) in the fourth quarter of 2018. For more information, visit www.tenaxthera.com.
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 acute 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.
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, new product introductions and customer acceptance of these new products; matters beyond the Company’s control that could impact the Company’s continued compliance with Nasdaq listing requirements; the impact of management changes on the Company’s business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; 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 April 2, 2018, its quarterly report on Form 10-Q filed on November 14, 2018 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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