Tenax Therapeutics Announces Late-Breaking Clinical Trial Presentation of Phase 2 HELP Study at Heart Failure Society of Amer...
October 02 2020 - 8:30AM
Business Wire
- HELP Study results will be presented on Saturday, October 3,
2020 at 4:30 pm EDT
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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201002005061/en/
Investor Contact: Westwicke Stephanie Carrington, 646-277-1282
Stephanie.carrington@westwicke.com
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