Tenax Therapeutics Announces Presentation of 24-Hour HELP Study Results at the American Heart Association Scientific Sessions...
November 10 2020 - 8:30AM
Business Wire
- HELP Study results presentation will be available online
beginning on November 13, 2020 at 9:00 a.m CST
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty
pharmaceutical company focused on identifying, developing, and
commercializing products for the critical care market, today
announced that data from the 24-hour open-label portion of the HELP
(Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Study will be
presented during the American Heart Association (AHA) Scientific
Sessions 2020 that is being conducted online from November 13, 2020
– November 17, 2020.
The phase 2 HELP Study enrolled patients with pulmonary
hypertension and heart failure with preserved ejection fraction and
was designed to evaluate levosimendan’s hemodynamic and clinical
effects during rest and exercise. The initial phase of the trial
was open-label and designed to identify patients who elicited a
hemodynamic response following a 24-hour infusion of levosimendan.
Patients who met the prespecified response criteria of ≥4 mmHg
reduction in pulmonary capillary wedge pressure during supine
bicycle exercise were deemed to be responders and were randomized
to a 6-week double-blind placebo-controlled phase of the trial.
The 24-hour HELP Study results being presented at AHA include
data from a total of 44 patients, of which 36 (~85%) were
determined to be responders. Details regarding the presentation are
as follows:
Title:
24-hour Levosimendan Infusion Decreases
Biventricular Filling Pressures at Rest and Exercise in
PH-HFpEF
Author:
Daniel Burkhoff, MD PhD, Director Heart
Failure, Hemodynamics and MCS Research at the Cardiovascular
Research Foundation., et al
Session:
Novel Translational Insights for Pulmonary
Vascular and RV Remodeling
Date/Time:
Available OnDemand beginning Friday,
November 13, 2020 at 9:00 a.m. CST
The above presentation will be available to conference
registrants for viewing on the AHA Scientific Session’s Virtual
Platform at
https://professional.heart.org/es/meetings/scientific-sessions.
Tenax Therapeutics’ CEO, Tony Ditonno, stated, “We are very
excited to have these additional HELP Study results presented at
the American Heart Association meeting. The results are very
complimentary and supportive of the 6 week-double blind randomized
phase of the HELP Study that was recently presented as a
late-breaking clinical trial at the Heart Failure of Society of
America, and we are very excited to have this additional 24-hour
data being shared 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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Investor Contact: Westwicke Stephanie Carrington, 646-277-1282
Stephanie.carrington@westwicke.com
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