Tag: Failure

Tenax Therapeutics Announces Late-Breaking Clinical Trial Presentation of Phase 2 HELP Study at Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting

MORRISVILLE, N.C.–(BUSINESS WIRE)–Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that detailed results from the Phase 2 HELP Study of levosimendan in PH-HFpEF will be presented at the upcoming Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting to be held September 30, – October 6. Scheduling details and registration information are provided below:

Title:

 

Levosimendan Improves Hemodynamics and Submaximal Exercise Capacity In PH-HFpEF: Primary Results From The HELP-PH-HFpEF Multicenter Randomized Controlled Trial

 

 

Speaker:

 

Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic

 

 

Session:

 

Late-Breaking Clinical Trials I (LBCT I)

 

 

Date/Time:

 

Saturday, October 3, 4:30 – 5:30 PM

   

Registration and additional HFSA information are available at the HFSA website: https://hfsa.org/hfsa-announces-late-breaking-clinical-trials-sessions-hfsa-virtual-asm-2020.

Tenax CEO Anthony DiTonno stated, “We are very excited to have the HELP Study results presented as a late-breaking clinical trial at the HFSA Annual Meeting. We believe the results may represent a potential advance in the treatment of PH-HFpEF patients who currently have no FDA-approved therapies to treat their condition. We look forward to having the detailed trial results presented at this major scientific forum.”

About Phase 2 HELP Trial

The HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Endpoints in the trial evaluated various invasive hemodynamic and clinical measures including a 6-minute walk test. The Company previously announced positive topline results from this Phase 2 trial. The trial demonstrated significant reduction in right atrial and pulmonary capillary wedge pressures. It also demonstrated a significant improvement with 6-minute walk distance.

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 has recently released topline data regarding 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.

About Levosimendan

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

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