Tenax Therapeutics Activates First Clinical Research Site for Phase 2 Pulmonary Hypertension Clinical Trial
November 19 2018 - 8:00AM
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 Stanford University School of Medicine has been
activated as the first clinical research site 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 is also known as the H-E-L-P Trial
(Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF)
and is expected to enroll a total of 36 PH-HFpEF patients at up to
approximately 12-15 major research institutions across the US.
Anthony DiTonno, CEO of Tenax Therapeutics, Inc., stated, “We
are very excited to have activated our first site for the HELP
trial. We are equally excited that so many highly regarded medical
centers and principal investigators have indicated strong interest
in participating in the trial and we expect to have several
additional site activations in 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 finalizing preparations to begin
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) in the fourth quarter of
2018. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181119005053/en/
Investor Contact:ICRStephanie Carrington,
646-277-1282stephanie.carrington@icrinc.com
Tenax Therapeutics (NASDAQ:TENX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Tenax Therapeutics (NASDAQ:TENX)
Historical Stock Chart
From Apr 2023 to Apr 2024