Tenax Announces Late-Breaking Results from the HELP Study Accepted for Presentation at the Heart Failure Society of America (...
August 31 2020 - 8:30AM
Business Wire
- HELP Study results, evaluating levosimendan in patients with
Pulmonary Hypertension and Heart Failure with Preserved Ejection
Fraction (PH-HFpEF), will be presented during a Late-Breaking
Clinical Trial session during the HFSA Annual Scientific
Meeting
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 have been accepted for presentation as a
Late-Breaking Clinical Trial at this year’s Heart Failure Society
of America (HFSA) Annual Scientific Meeting to be held September
30, 2020-October 6, 2020.
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.
Detailed results of the HELP Study will be presented as a
late-breaking oral abstract by Dr. Barry Borlaug, Chair for
Research, Division of Circulatory Failure, Department of
Cardiovascular Medicine at the Mayo Clinic and a member of the HELP
Study Steering Committee.
Tenax CEO Anthony DiTonno stated “We are very excited to have
the HELP Study results accepted for presentation as a late-breaking
abstract at the HFSA Annual Meeting. The positive results of the
HELP Study represent a major milestone for Tenax and our
development of levosimendan for the treatment of patients suffering
from this debilitating illness. Based on feedback from our
advisors, we believe the results may represent a potential
breakthrough in the treatment of PH-HFpEF patients, and we look
forward to having the detailed trial results presented at this
major scientific forum.”
About Phase 2 HELP Trial
The HELP Trial – Hemodynamic Evaluation of Levosimendan in
PH-HFpEF is 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). The trial has a predefined response
criterion that patients must meet following a 24-hour open-label
infusion of levosimendan before they can be randomized to the
6-week double-blind phase of the trial. The criterion for
randomization is a reduction in PCWP during supine exercise of ≥
4mmHg following the open-label infusion when compared with each
patient’s baseline exercise PCWP. The primary endpoint of the HELP
Trial is based on change in PCWP vs baseline compared to
placebo.
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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Investor Contact: Westwicke Stephanie Carrington, 646-277-1282
Stephanie.carrington@westwicke.com
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