Tenax Therapeutics Enrolls First Patient for Phase 2 Pulmonary Hypertension Clinical Trial
March 11 2019 - 8:30AM
Business Wire
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty
pharmaceutical company focused on identifying, developing and
commercializing products that address cardiovascular and pulmonary
diseases with high unmet medical need, today announced that the
first patient has been randomized for the Company’s Phase 2 trial
designed to evaluate levosimendan in patients with pulmonary
hypertension and heart failure with preserved ejection fraction
(PH-HFpEF). The study, also known as the HELP Trial (Hemodynamic
Evaluation of Levosimendan in Patients with PH-HFpEF), is designed
to enroll a total of 36 PH-HFpEF patients at up to approximately
10-12 major research institutions across the US.
Anthony DiTonno, CEO of Tenax Therapeutics, Inc., stated,
“Enrolling our first patient is an important milestone for the HELP
trial. We have been working closely with our highly regarded
principal investigators who are actively screening patients for the
trial, and we expect additional centers to start enrolling patients
over the coming weeks.”
The HELP Trial is designed to evaluate the hemodynamic benefits
of levosimendan, compared to placebo in patients with PH-HFpEF. In
addition to the previously conducted preclinical and clinical
studies, the trial design has been informed by the substantial
clinical experience that comes from more than one million patients
who have been treated in over 60 countries where levosimendan is
currently approved to treat acute heart failure.
PH-HFpEF represents an area of very high unmet medical need. No
approved or effective therapies currently exist to treat the many
patients who suffer with PH-HFpEF. Preliminary data from
preclinical and clinical studies of pulmonary hypertension and
heart failure patients provide a reason to believe that
levosimendan may provide important benefits for PH-HFpEF
patients.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company
focused on identifying, developing and commercializing products for
the critical care market. The Company has a world-class scientific
team including recognized global experts in pulmonary hypertension.
The Company owns the North American rights to develop and
commercialize levosimendan and is currently enrolling 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 acute 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 the 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 April 2, 2018,
its quarterly report on Form 10-Q filed on November 14, 2018 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/20190311005094/en/
ICRStephanie Carrington,
646-277-1282Stephanie.carrington@icrinc.com
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