Tenax Therapeutics Provides Clinical Development Update
August 23 2019 - 7:00AM
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 provided an update on
its on-going clinical trial of levosimendan.
Clinical Development Update
Tenax is conducting a multi-center, double-blind placebo
controlled 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 HELP Trial (Hemodynamic Evaluation of Levosimendan in Patients
with PH-HFpEF). There are currently 12 activated sites, with an
additional three sites expected to be activated over the next few
weeks, which we believe will be sufficient to fully enroll the
trial. Eight patients, up from three at the end of June, are
currently enrolled out of the targeted 36 patients. Three of the
eight patients have completed the initial 6-week HELP protocol and
have rolled over into the 2-year extension phase
Anthony DiTonno, CEO of Tenax Therapeutics, commented, “We are
pleased with the progress made over the past few months to
advancing the Phase 2 trial. Based on feedback from our principal
investigators we have modified and adapted our protocols for the
HELP trial. These modifications, in addition to achieving our
targeted number of clinical sites, have resulted in an acceleration
in the pace of patient enrollment. Given the momentum in the
quarter, we now expect full enrollment and top-line data in the
HELP Trial in the first quarter of 2020. We are also pleased to
announce that the company has developed and recently filed a patent
application for a subcutaneous formulation of levosimendan. Future
development activities will be finalized following the completion
of our phase 2 HELP trial and subsequent discussion with the FDA on
a phase 3 trial for PH-HFpEF patients.”
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 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 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 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 1, 2019,
its quarterly report on Form 10-Q filed on August 14, 2019 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/20190823005013/en/
Investor Contact: ICR Stephanie Carrington, 646-277-1282
Stephanie.carrington@icrinc.com
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