Tenax Therapeutics to Host KOL Event: “LEVEL Setting: the Scientific Rationale for Levosimendan as a Potential First Treatment for PH-HFpEF, and the Ongoing Phase 3 LEVEL Study”
Panel of renowned cardiologists, all globally recognized experts in heart failure, will discuss the unmet medical need in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) and the potential role for levosimendan in treating this prevalent, fatal disease
Experts will explain pathophysiology of PH-HFpEF, and mechanistic rationale for levosimendan
Update on the ongoing Phase 3 LEVEL Study evaluating TNX-103 (oral levosimendan) for the treatment of PH-HFpEF
Tenax to Host Webcast on Thursday, April 18, 2024, at 10:00 am ET
CHAPEL HILL, N.C., April 09, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that Stuart Rich, Tenax CMO, will moderate ”LEVEL Setting," a scientific round-table exploration of the rationale for TNX-103 (oral levosimendan), for the treatment of PH-HFpEF.
Presentations from four globally recognized experts in the field of heart failure will explore this most prevalent type of pulmonary hypertension and the therapeutic potential of levosimendan:
Understanding the setting of PH-HFpEF – Sanjiv Shah, M.D. (Northwestern University)
Mechanism of Action of Levosimendan – Daniel Burkhoff, M.D., Ph.D. (Columbia)
Review of data from the Phase 2 HELP Study – Barry Borlaug, M.D. (Mayo Clinic)
Current treatment landscape in PH-HFpEF – Javed Butler, M.D., M.P.H., M.B.A. (Baylor Scott & White)
Following the seminar, members of Tenax Therapeutics senior management will provide a brief update on the ongoing Phase 3 LEVEL Study, followed by a Q&A session with the experts.
Dr. Sanjiv Shah is the Stone Endowed Professor of Medicine, Director of Research for the Bluhm Cardiovascular Institute, and Director of the HFpEF Program at Northwestern University Feinberg School of Medicine. His clinical expertise is in HFpEF, pulmonary hypertension, echocardiography, hemodynamics, and rare cardiomyopathies such as cardiac amyloidosis. Dr. Shah’s research interests include understanding the physiology, mechanisms, epidemiology, and treatment of HFpEF. He started the first dedicated HFpEF clinical program in the world at Northwestern University in 2007, now a model for programs around the world, and has been the overall principal investigator or on the steering committee/executive committee of > 35 multicenter, randomized HF clinical trials. His research interests also include the study of acquired and genetic risk factors for abnormal cardiac mechanics, and novel machine learning techniques for improved classification and therapeutic targeting for HF syndromes. Dr. Shah is currently the PI of multiple active NIH R01 grants and an AHA Strategically Focused Research Network project grant. Dr. Shah has published over 355 peer-reviewed research publications, and he is an Associate Editor for JAMA Cardiology.
Daniel Burkhoff, M.D., Ph.D.
Dr. Burkhoff obtained Doctor of Philosophy and Medical degrees from The Johns Hopkins School of Medicine and completed a fellowship in Cardiology at The Johns Hopkins Hospital. Dr. Burkhoff then moved to Columbia University in the City of New York where he established and ran the Cardiovascular Research Laboratory through 2003 and then took the position of Director of the Jack Skirball Center for Cardiovascular Research of the Cardiovascular Research Foundation (CRF) through 2005. His focus shifted to development and research of medical devices in his capacity as Medical Director of several startup companies involved in diagnostics and therapies for heart failure. Dr. Burkhoff then returned to CRF as Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research. In this capacity, he also directs CRF’s educational program called “TEACH” (Training and Education in Advanced Cardiovascular Hemodynamics). Dr. Burkhoff’s interests include cardiovascular modeling and research in basic and clinical aspects of ventricular mechanics, cardiovascular monitoring, heart failure, device and pharmacologic treatments for heart failure, including left ventricular assist devices. He is also the author of Harvi, an interactive simulation-based application for teaching and researching many aspects of ventricular mechanics and hemodynamics.
Barry Borlaug, M.D.
Dr. Borlaug is Professor of Medicine and Director, Circulatory Failure Research, Division of Cardiovascular Diseases, and Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic, Rochester, Minnesota. After graduating from medical school at the University of Wisconsin, Dr. Borlaug trained in internal medicine at the Brigham and Women’s Hospital in Boston, Massachusetts and cardiovascular medicine at the Johns Hopkins Hospital in Baltimore, Maryland prior to joining the cardiovascular division of the Mayo Clinic in Rochester, Minnesota where he is currently Associate Professor of Medicine and Director of Circulatory Failure research. Dr. Borlaug’s research interests focus on the pathophysiology, diagnosis and treatment of heart failure, particularly heart failure with preserved ejection fraction, with an emphasis on hemodynamics. He has published over 400 articles in peer reviewed journals on these topics. Dr. Borlaug is an active member of the American College of Cardiology, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and the Society of Cardiac Angiographers and Interventionalists.
Javed Butler, M.D., M.P.H., M.B.A.
Javed Butler, M.D., M.P.H., M.B.A., is the President of the Baylor Scott & White Research Institute and Senior Vice President for Baylor Scott & White Health. He is also the Distinguished Professor of Medicine at the University of Mississippi in Jackson, MS. Dr. Butler earlier served as the Patrick H. Lehan Chair in Cardiovascular Research, and Professor and Chairman of the Department of Medicine at the University of Mississippi, where he was also Professor of Physiology and Biophysics. He was previously Charles A. Gargano Chair in Cardiovascular Research and Director of the Division of Cardiovascular Medicine and Co-Director of the Heart Institute at Stony Brook University, New York; Director for Heart Failure Research at Emory University; and Director of the Heart and Heart-Lung Transplant Programs at Vanderbilt University. He received his medical degree from the Aga Khan University and then completed residency training at Yale University, cardiology fellowship and advanced heart failure and transplant fellowships at Vanderbilt University, and cardiac imaging fellowship at the Massachusetts General Hospital at the Harvard Medical School. He received a Master of Public Health degree from Harvard University, and an MBA from Emory University.
The LEVEL Study is a Phase 3, double-blind, randomized, placebo-controlled study of levosimendan in patients with PH-HFpEF. Approximately 152 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan (2 mg/day) or placebo for Weeks 1 to 4 and 3 mg/day or placebo for Weeks 5 to 12. The primary outcome measure for the study is change in six-minute walk distance from Baseline to Week 12. All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.
About Levosimendan (TNX-101, TNX-102, TNX-103)
Levosimendan is a unique, potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action. Initially discovered and developed by Orion Corporation in Finland, intravenous levosimendan is approved in 60 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Results of Tenax Therapeutics’ Phase 2 HELP study of levosimendan in patients with pulmonary hypertension (PH) with heart failure with preserved ejection fraction (HFpEF) demonstrated that I.V. levosimendan produces potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity, a discovery that is the basis of LEVEL, the Phase 3 investigation of Tenax Therapeutics’ potential groundbreaking therapy. To date, no other drug therapy has improved exercise tolerance in patients with PH associated with HFpEF, “a growing epidemic with high morbidity and mortality and no treatment. The clear unmet need and lethal nature of PH-HFpEF must be met with novel solutions at all levels of therapeutic development” (AHA Scientific Advisory, “A Call to Action,” 2022).
About Tenax Therapeutics
Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company owns global rights to develop and commercialize levosimendan, which it has prioritized in the near term. Tenax Therapeutics also may resume developing its unique oral formulation of imatinib. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.
Caution Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; risks related to our business strategy, including the prioritization and development of product candidates; intellectual property risks; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; our competitive position; risks related to our continued listing on Nasdaq; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; volatility and uncertainty in the global economy and financial markets in light of the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.
Contacts
Investor Contact: John Fraunces Managing Director LifeSci Advisors, LLC C: 917-355-2395, or
Brian Mullen LifeSci Advisors, LLC C: 203-461-1175
