Tenax Therapeutics Announces First Patients Enrolled in Phase 3 LEVO-CTS Clinical Trial of Levosimendan
September 22 2014 - 8:30AM
Business Wire
- North American study is evaluating
levosimendan in cardiac surgery patients at risk of developing low
cardiac output syndrome (LCOS) –
- FDA has granted Fast Track status for
levosimendan in LCOS, agreed to Phase 3 protocol design under SPA
–
- Full data readout expected in first quarter
of 2016 –
Tenax Therapeutics, Inc. (NASDAQ: TENX), formerly Oxygen
Biotherapeutics, Inc., a specialty pharmaceutical company focused
on developing and commercializing a portfolio of products for the
critical care market, today announced that the first patients have
been enrolled in the LEVO-CTS Phase 3 trial designed to assess the
benefits of levosimendan in cardiac surgery patients at risk of
developing low cardiac output syndrome (LCOS).
“We are pleased to begin this important Phase 3 study, which has
been designed in consultation with leading cardiovascular experts
and investigators to provide a clear answer on the potential of
levosimendan to prevent complications after high-risk cardiac
surgery,” said John Kelley, CEO of Tenax Therapeutics. “We look
forward to working with our colleagues at Duke Clinical Research
Institute and the other cardiac surgery centers and hospitals
involved in the trial, as we continue to activate many additional
clinical sites in the months ahead.”
LEVO-CTS is a multi-center, double blind, randomized,
placebo-controlled clinical trial that is testing the hypothesis
that levosimendan reduces morbidity and mortality in cardiac
surgery patients at risk for developing (LCOS). The U.S. Food and
Drug Administration (FDA) has already granted Fast Track status for
levosimendan in this LCOS indication, and agreed to the Phase 3
protocol design under Special Protocol Assessment (SPA) with
guidance that this single successful trial will be sufficient to
support approval.
“The LEVO-CTS trial design will test levosimendan in the
prevention of LCOS in high-risk patients undergoing cardiac surgery
– an area of high unmet medical need and one where several smaller
published clinical trials have suggested potential benefit,” said
lead investigator John H. Alexander, M.D., MHS, Director of
Cardiovascular Research, Duke Clinical Research Institute (DCRI).
“We are pleased to be getting started with enrollment and are
projected to have results in early 2016.”
The LEVO-CTS trial is being led by DCRI and will take place at
approximately 50 major cardiac surgery centers in North America. It
is seeking to enroll 760 patients undergoing coronary artery bypass
graft surgery or mitral valve surgery that are at risk for
developing LCOS.
The trial is event-driven, and includes a review of the event
rate after the first 200 patients have been randomized in the
trial. Two interim analyses will test for efficacy or futility
after 50% and 70% of the planned primary endpoint events have been
recorded.
The full protocol for this trial has been published on
ClinicalTrials.gov (NCT02025621).
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 50 countries for this indication and not available in the
United States. Tenax Therapeutics recently acquired the North
American rights to develop and commercialize levosimendan from
Phyxius Pharma. The United States Food and Drug Administration
(FDA) has granted Fast Track status for levosimendan for the
reduction of morbidity and mortality in cardiac surgery patients at
risk for developing Low Cardiac Output Syndrome (LCOS). In
addition, the FDA has agreed to the Phase 3 protocol design under
Special Protocol Assessment (SPA), and provided guidance that a
single successful trial will be sufficient to support approval of
levosimendan in this indication.
About Tenax Therapeutics
Tenax Therapeutics, Inc. (formerly Oxygen Biotherapeutics) is a
specialty pharmaceutical company focused on developing and
commercializing a portfolio of products for the critical care
market. The company owns the North American rights to develop and
commercialize levosimendan, and the United States Food and Drug
Administration (FDA) has granted Fast Track status for levosimendan
for the reduction of morbidity and mortality in cardiac surgery
patients at risk for developing Low Cardiac Output Syndrome (LCOS).
The company initiated a Phase 3 trial with levosimendan in that
indication in July 2014. For more information, visit
www.tenaxthera.com.
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,
delays in new product introductions and customer acceptance of
these new products, and other risks and uncertainties as described
in the company’s filings with the Securities and Exchange
Commission, including in its quarterly report on Form 10-Q filed on
September 15, 2014 and annual report on Form 10-K filed on July 29,
2014, 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.
Investor Contact:Stern Investor Relations, Inc.Jesse
Baumgartner, 212-362-1200jesse@sternir.comorMedia
Contact:Porter NovelliChad Hyett,
212-601-8242chad.hyett@porternovelli.com
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