Exhibit 99.1
Tenax Therapeutics Announces Top-Line Results From
Phase 3 LEVO-CTS Trial in Cardiac Surgery
– Study Did Not Achieve
Statistically Significant Reductions in Dual or Quad Primary
Endpoints –
–
Study Met Two Secondary Endpoints
with Statistically Significant Reduction in Incidence of LCOS and
Use of Postoperative Secondary Inotropes
–
Morrisville, NC, January 31, 2017 – Tenax Therapeutics, Inc. (NASDAQ: TENX), a
specialty pharmaceutical company focused on identifying, developing
and commercializing products for the critical care market, today
announced top-line results from its Phase 3 LEVO-CTS trial. The
study did not achieve statistically significant reductions in the
dual endpoint of death or use of a mechanical assist device at 30
days, nor in the quad endpoint of death, myocardial infarction,
need for dialysis, or use of a mechanical assist device at 30 days.
However, the study demonstrated statistically significant
reductions in two of three secondary endpoints including reduction
in low cardiac output syndrome (LCOS) and a reduction in
postoperative use of secondary inotropes. Patient visits for data
on death through day 90 have not yet been completed. The Company
has a meeting scheduled with the U.S. Food and Drug Administration
(FDA) to review the preliminary trial data and discuss a path
forward to bring this potentially lifesaving treatment to the
benefit of patients undergoing serious cardiac
surgery.
“We are disappointed and surprised by the top-line results
from this trial, especially given the promising results from
earlier published clinical trials. On the other hand, we are
encouraged by the statistically significant reduction in incidence
of LCOS and use of postoperative secondary inotropes, both of which
we believe are clinically important. This is consistent with what
we know about how this drug works. In addition, we continue to
review the full data set, including the in-process data collection
on all-cause mortality through day 90, and will share our complete
findings at the upcoming American College of Cardiology (ACC)
meeting in March,” said John Kelley, CEO of Tenax
Therapeutics. “We thank our clinical collaborators and their
patients who participated in this clinical trial with the hope of
improving not only their own outcomes, but also the outcomes of
future patients undergoing cardiac surgery.”
Analyses of the LEVO-CTS trial results are ongoing and will be
presented on Sunday, March 19, 2017, at 8:00 am EDT during a
late-breaking clinical trial session at the American College of
Cardiology 66th Annual Scientific Session in Washington,
D.C.
The full LEVO-CTS trial design was recently published by the
study’s investigators in the American Heart Journal
in an article titled,
“Levosimendan in
Patients with Left Ventricular Systolic Dysfunction Undergoing
Cardiac Surgery on Cardiopulmonary Bypass: Rationale and Study
Design of the LEVO-CTS Trial.”
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.
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 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). 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 transition report on Form 10-KT filed
on March 14, 2016, its quarterly report on Form 10-Q filed on
November 9, 2016 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
Will O‘Connor
Stern Investor Relations, Inc.
will@sternir.com
212-362-1200