MORRISVILLE, N.C., May 25, 2022--(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 it will host a key opinion leader (KOL) webinar about TNX-201 (oral, modified release imatinib), in development as a potential treatment for pulmonary arterial hypertension (PAH), on Thursday, June 2, 2022 at 11:00am Eastern Time.
The webinar will feature presentations from renowned medical experts in the field of pulmonary hypertension:
Anna Hemnes, MD, of Vanderbilt University Medical Center
John Ryan, MD, MB, BCH, BAO, of the University of Utah
Bradley Maron, MD, of Harvard Medical School
Robert Frantz, MD, FACC, of Mayo Clinic College of Medicine.
The discussion will focus on the current pulmonary arterial hypertension (PAH) treatment landscape and on the potential future role of TNX-201, a novel, oral, modified release formulation of imatinib developed by Tenax Therapeutics. Results from a previous Phase 3 study, IMPRES, which evaluated GLEEVEC® (imatinib mesylate) for the treatment of PAH, will also be discussed.
A live question and answer session will follow the formal presentations.
To register for the event, please click here.
Anna Hemnes, MD is an Associate Professor of Medicine in the Division of Allergy, Pulmonary & Critical Care Medicine at the Vanderbilt University Medical Center. She is a renowned translational physician-scientist with a research focus on the role of altered metabolism in pulmonary vascular disease. Her interest in molecular phenotypes of pulmonary vascular disease has led to work demonstrating an Omic signature of vasodilator-responsive pulmonary arterial hypertension, which was one of the earliest publications demonstrating the feasibility of precision medicine in an ultra-rare pulmonary vascular disease. The Hemnes lab is now actively investigating novel blood-based Omic predictive strategies for FDA-approved therapies for pulmonary arterial hypertension. Dr. Hemnes also has clinical responsibilities which include managing patients in the Vanderbilt Center for Pulmonary Vascular Disease. She has effectively worked with this population to recruit into clinical studies for pulmonary vascular disease, including the treatment of pulmonary hypertension, diagnostic modalities in pulmonary vascular disease and novel classification of pulmonary vascular disease. She was recently appointed the new Editor in Chief of the journal Pulmonary Circulation.
John Ryan, MD, MB, BCH, BAO is an internationally renowned specialist in Cardiovascular Medicine and Pulmonary Hypertension. He is Associate Professor in the Division of Cardiovascular Medicine at the University of Utah. He is an author on the guidelines from the ACCP on the treatment of Pulmonary Hypertension. Dr. Ryan also is a Sports Cardiology Consultant for the United States Olympic Committee, the International Olympic Committee, the National Basketball Association, Major League Soccer and the NCAA. Dr. Ryan has published over 130 research publications, including in leading medical journals such as The New England Journal of Medicine, Nature Medicine, The British Medical Journal, Circulation, CHEST, and The Journal of the American College of Cardiology.
Bradley Maron, MD is an Assistant Professor of Medicine at Harvard Medical School, Associate Physician in the Division of Cardiovascular Medicine at Brigham and Women’s Hospital, and Co-director of the Pulmonary Vascular Disease Center at the VA Boston Healthcare System. His laboratory focus involves utilizing network medicine and systems biology to characterize the pathobiological mechanisms underpinning complex cardiovascular disease. Through these approaches, Dr. Maron identified a critical cysteinyl thiol redox switch as well as a pro-thrombotic peptide in the CAS protein NEDD9 that regulate pulmonary vascular fibrosis and thrombosis, respectively. These molecular targets have emerged as potentially modifiable small molecule and antibody technologies. In collaborative work, he led international projects focusing on the hemodynamic spectrum of clinical risk in pulmonary hypertension, which have provided new insights on pulmonary artery pressure and pulmonary vascular resistance levels associated with adverse clinical outcomes. More recently, he has applied network medicine to individualizing the pathobiology of patients with hypertrophic cardiomyopathy. Dr. Maron has co-authored numerous scientific manuscripts, is the co-inventor of several patents or pending patents, and is funded by the National Institutes of Health, American Heart Association, and many other Foundations. He is a member of the American Society of Clinical Investigation, a recipient of the distinguished Eleanor and Miles Shore Scholar in Medicine fellowship, a McKenzie Family Master Clinician, and a recipient of Harvard Medical School’s Excellence in Teaching Awards.
Robert Frantz, MD, FACC is Professor of Medicine at Mayo Clinic College of Medicine. He joined the staff of Mayo Clinic in 1990, where he currently serves as Director of the Pulmonary Hypertension Clinic and Director of the Unexplained Dyspnea Clinic. Dr. Frantz’ research comprises the varied forms of pulmonary hypertension, pulmonary vascular disease and right heart failure, including pathophysiology, hemodynamics, causes of exercise limitation and optimal management strategies. His research centers on defining best strategies for management of chronic thromboembolic pulmonary hypertension, including coordination of an active program of balloon pulmonary angioplasty. Dr. Frantz is currently serving as a site principal investigator for National Heart, Lung, and Blood Institute studies on "Redefining Pulmonary Hypertension through Pulmonary Vascular Disease Phenomics." Additionally, he has authored or co-authored well over 200 peer-reviewed publications.
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 world-class scientific advisory teams, including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize subcutaneous and oral formulations of levosimendan and has recently released detailed results from the Phase 2 HELP Study of levosimendan in Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) at the Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting, and in the Journal of the American College of Cardiology: Heart Failure. Tenax Therapeutics is also developing a unique oral formulation of imatinib designed to minimize the gastric irritation observed in a previous Phase 3 trial of the marketed version of the therapy while assuring that the dose achieved is at the level necessary for the drug to be effective. Tenax Therapeutics expects to conduct a single pivotal trial pursuant to the 505(b)(2) pathway for regulatory approval. For more information, visit www.tenaxthera.com.
About Imatinib (TNX-201)
Tenax Therapeutics is developing novel dosing and a unique formulation of imatinib mesylate, a kinase inhibitor that has received FDA’s orphan designation (March 2020) for the treatment of pulmonary arterial hypertension (PAH). The IMPRES trial, a previous Phase 3 trial, demonstrated that oral imatinib may produce a markedly greater, and much more durable, treatment effect on exercise tolerance, than any other available PAH treatment, alone or in combination, based on the results observed in those patients who were maintained on the full imatinib dose for the majority of the trial. Despite the availability of several classes of pulmonary vasodilators, no existing treatment has been shown to halt progression or induce regression of the disease. Imatinib acts on underlying cellular proliferative pathways associated with PAH and has the potential to be the first disease modifying therapy for PAH. Tenax Therapeutics intends to commence a Phase 3 trial of TNX-201 in 2H 2022.
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. 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 maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing and customer acceptance of our product candidates; intellectual property risks; our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic; 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.
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