MORRISVILLE, N.C--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ: TENX) a leading specialty pharmaceutical company focused on providing products to address conditions with significant unmet medical needs, today announced the appointment of three internationally recognized medical experts in the fields of pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) to its Scientific Advisory Board for the company’s planned Phase 2 clinical study in the use of levosimendan for patients with PH-HFpEF.
The scientific advisory board will be chaired by Stuart Rich, M.D., Professor of Medicine Northwestern University Feinberg School of Medicine and Director, Pulmonary Vascular Disease Program, Bluhm Cardiovascular Institute. Two additional world leading experts will join Dr. Rich as inaugural members of the scientific advisory board: Daniel Burkhoff MD, PhD, 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.
Dr. Rich stated, “I am excited to serve on this scientific advisory board with Dr. Burkhoff and Dr. Shah as they are both highly respected researchers and clinicians who have a common interest in developing novel therapies, such as levosimendan, for PH-HFpEF patients.”
This scientific advisory board of world recognized experts will guide Tenax’s clinical development of levoismendan in PH-HFpEF, including the design and execution of a Phase 2 trial that Tenax plans to initiate later this year. Michael Jebsen, Interim CEO of Tenax Therapeutics said, “We are very pleased to have attracted such a prestigious group of researchers and clinicians to serve as our scientific advisors. It is particularly notable that all three have been involved in multiple clinical trials and are very experienced in trial designs for novel therapeutics.”
Commenting on his appointment, Dr. Dan Burkhoff said, “I am excited to serve in this advisory capacity. I believe levosimendan offers significant promise as a potential therapy for PH-HFpEF patients who currently have no effective alternatives.”
Dr. Shah added, “I look forward to supporting the development of levosimendan in PH-HFpEF both as a member of the scientific advisory board as well as a principal investigator in the planned Phase 2 trial of levosimendan.”
Brief biographies of the Scientific Advisory Board members are listed below.
Stuart Rich, M.D.
Dr. Rich is Professor of Medicine Northwestern University Feinberg School of Medicine, and Director, Pulmonary Vascular Disease Program Bluhm Cardiovascular Institute. Dr. Rich has a career interest in understanding the causes and treatments of pulmonary hypertension. He was principal investigator for the National Institutes of Health (NIH) Registry on Primary Pulmonary Hypertension, the first of its kind, and has been the leader of the largest clinical centers in the USA for evaluating and treating patients with pulmonary hypertension since 1980. Dr. Rich has conducted pioneering research on the molecular mechanisms, epidemiology, clinical presentation, natural history and treatments of the disease. This knowledge has led to the discovery of more effective treatments for pulmonary hypertension, including the use of medicines like anticoagulants, calcium channel blockers, and prostacyclins. Dr. Rich was instrumental in the current classification system routinely used by physicians in characterizing the types of pulmonary hypertension. Dr. Rich was also a recent member of the Food and Drug Administration (FDA) Cardiovascular and Renal Advisory Committee.
During his distinguished career Dr. Rich has authored and published hundreds of articles and book chapters on pulmonary hypertension. He has received numerous awards recognizing his achievements including, the Heart for Hope Legacy Award from the Pulmonary Hypertension Association and the Lifetime Achievement Award from the Pulmonary Vascular Research Institute.
Daniel Burkhoff MD, PhD
Dr. Burkhoff is Director Heart Failure, Hemodynamics and MCS Research at the Cardiovascular Research Foundation (CRF) and Adjunct Associate Professor of Medicine, Columbia University. Dr. Burkhoff is a world-renowned expert in heart failure and hemodynamics. His expertise and clinical research is focused on heart failure, including ventricular assist devices, ventricular mechanics and cardiovascular physiology. Dr. Burkhoff is the creator of the Harvi simulator, an interactive application that gives healthcare providers a better understanding of the fundamentals of hemodynamics. It was designed to help educate physicians at all levels of training on hemodynamics and to assist them in predicting the effects of different therapies, as well as aid in patient selection for new therapies. He has authored over 300 peer-reviewed journal articles, book chapters and editorials. Before rejoining CRF in 2016, he was Vice President of Medical Science for HeartWare International. Previously, he served as Medical Director of CircuLite and Cheetah Medical.
Sanjiv Shah, MD, FAHA, FACC, FASE
Dr. Shah is Professor of Medicine and Director of the T1 Center for Cardiovascular Therapeutics at Northwestern University Feinberg School of Medicine. Dr. Shah’s research interests include understanding the physiology, mechanisms, and epidemiology of HFpEF. Dr. Shah started the first dedicated HFpEF clinical program at Northwestern University in 2007, and has been a leading enroller in clinical trials for HFpEF since that time. Dr. Shah’s 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 of heart failure syndromes. Dr. Shah’s research is currently funded by multiple NIH and American Heart Association grants, and he is also a steering committee member for several ongoing international heart failure clinical trials. Dr. Shah has published over 250 original papers, abstracts, book chapters, and review articles, and he is an Associate Editor for JAMA Cardiology. He has also received several teaching awards throughout his career, including the W. Proctor Harvey Teaching Award from the American College of Cardiology.
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.
About Tenax Therapeutics
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.
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 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.