Tenax Therapeutics Announces Late-Breaking Clinical Trial Presentation of Phase 2 HELP Study at Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting
Tenax Therapeutics (Nasdaq: TENX) has announced the presentation of detailed results from the Phase 2 HELP Study on levosimendan for pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) at the upcoming HFSA Virtual Annual Meeting from September 30 to October 6. The study demonstrated significant hemodynamic improvements and enhanced exercise capacity. CEO Anthony DiTonno expressed optimism regarding the potential of levosimendan as a groundbreaking treatment, given there are currently no FDA-approved therapies for this condition.
- Successful presentation of Phase 2 HELP Study results at HFSA.
- Significant hemodynamic improvements observed with levosimendan.
- Enhanced exercise capacity noted in patients with PH-HFpEF.
- None.
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 |
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Speaker: |
Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic |
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Session: |
Late-Breaking Clinical Trials I (LBCT I) |
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Date/Time: |
Saturday, October 3, 4:30 - 5:30 PM |
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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 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, new product introductions and customer acceptance of these new products; matters beyond the Company’s control that could impact the Company’s continued compliance with Nasdaq listing requirements; the impact of management changes on the Company’s business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; 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 30, 2020, and its quarterly report of Form 10-Q filed on August 14, 2020, 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.
