MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic has joined our scientific advisory board. Tenax CEO Tony DiTonno stated: “We are very excited to have someone of Dr. Borlaug’s stature joining our scientific advisory board. Dr. Borlaug is a global leader in the fields of HFpEF and PH-HFpEF clinical research and is the leading enroller in the HELP Study. Dr. Borlaug’s expertise in the field, and his firsthand experience gained as a HELP Study investigator, make him an ideal addition to our scientific advisory board.”
Tenax is conducting a multi-center, double-blind, placebo-controlled 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 HELP Trial (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF). The Company has activated all 16 sites which it believes will be sufficient to fully enroll the targeted 36 patients. Given the current pace of patient enrollment, we expect full enrollment in the first quarter of 2020 with top-line data in the first half of 2020.
Dr. Borlaug was the first investigator to enroll a patient in the HELP Study and is the highest enrolling investigator to date with a total of 8 patients randomized at the Mayo Clinic. Dr. Borlaug stated, “I am excited to join my distinguished colleagues Dr. Stuart Rich, Dr. Sanjiv Shah, and Dr. Dan Burkhoff as members of the Tenax scientific advisory board and to be an investigator in the HELP Study. Hemodynamic responses observed during the open-label lead-in phase of the HELP Study have been impressive and I am hopeful that if we observe similar results in the double-blind phase of the trial that it could lead to the first therapy ever approved to treat PH-HFpEF patients.”
Dr. Borlaug joins the other distinguished members of our advisory board including Stuart Rich, MD, Northwestern, Professor of Medicine Northwestern University Feinberg School of Medicine and Director, Pulmonary Vascular Disease Program, Bluhm Cardiovascular Institute, Daniel Burkhoff MD, Ph.D., Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation and Adjunct Associate Professor of Medicine, Columbia University, and Sanjiv Shah, MD, Professor of Medicine Director, T1 Center for Cardiovascular Therapeutics, and Director, Northwestern HFpEF Program, Division of Cardiology, Department of Medicine Northwestern University Feinberg School of Medicine.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company has a world-class scientific advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and is currently enrolling 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). 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 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 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 1, 2019, its quarterly report on Form 10-Q filed on November 14, 2019 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.