Tenax Announces the Addition of Mayo Clinic Expert, Dr. Barry Borlaug, to Scientific Advisory Board
February 21 2020 - 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 Dr.
Barry Borlaug, Chair for Research, Division of Circulatory Failure,
Department of Cardiovascular Medicine at the Mayo Clinic has joined
our scientific advisory board. Tenax CEO Tony DiTonno stated: “We
are very excited to have someone of Dr. Borlaug’s stature joining
our scientific advisory board. Dr. Borlaug is a global leader in
the fields of HFpEF and PH-HFpEF clinical research and is the
leading enroller in the HELP Study. Dr. Borlaug’s expertise in the
field, and his firsthand experience gained as a HELP Study
investigator, make him an ideal addition to our scientific advisory
board.”
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). The Company has activated all 16 sites which it
believes will be sufficient to fully enroll the targeted 36
patients. Given the current pace of patient enrollment, we expect
full enrollment in the first quarter of 2020 with top-line data in
the first half of 2020.
Dr. Borlaug was the first investigator to enroll a patient in
the HELP Study and is the highest enrolling investigator to date
with a total of 8 patients randomized at the Mayo Clinic. Dr.
Borlaug stated, “I am excited to join my distinguished colleagues
Dr. Stuart Rich, Dr. Sanjiv Shah, and Dr. Dan Burkhoff as members
of the Tenax scientific advisory board and to be an investigator in
the HELP Study. Hemodynamic responses observed during the
open-label lead-in phase of the HELP Study have been impressive and
I am hopeful that if we observe similar results in the double-blind
phase of the trial that it could lead to the first therapy ever
approved to treat PH-HFpEF patients.”
Dr. Borlaug joins the other distinguished members of our
advisory board including Stuart Rich, MD, Northwestern, Professor
of Medicine Northwestern University Feinberg School of Medicine and
Director, Pulmonary Vascular Disease Program, Bluhm Cardiovascular
Institute, Daniel Burkhoff MD, Ph.D., Director Heart Failure,
Hemodynamics and MCS Research at the Cardiovascular Research
Foundation and Adjunct Associate Professor of Medicine, Columbia
University, and Sanjiv Shah, MD, Professor of Medicine Director, T1
Center for Cardiovascular Therapeutics, and Director, Northwestern
HFpEF Program, Division of Cardiology, Department of Medicine
Northwestern University Feinberg School of Medicine.
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 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 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 November 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/20200221005031/en/
Investor Contact: ICR Stephanie Carrington, 646-277-1282
Stephanie.carrington@icrinc.com
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