Tenax Therapeutics Activates First Clinical Research Site for Phase 2 Clinical Trial
Tenax Therapeutics, Inc. recently 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 to 15 major research institutions across the US.
Anthony DiTonno, CEO of Tenax Therapeutics, Inc., said “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 1 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.
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.
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