Tenax Therapeutics Provides Clinical Update for Lead Candidate Levosimendan
October 08 2015 - 7:30AM
Business Wire
- 200th patient enrolled in Phase 3 LEVO-CTS
trial for LCOS –
- LEVO-CTS protocol amendment approved by FDA,
significantly broadening potential patient population –
- 445 patients enrolled in LeoPARDS trial for
septic shock, out of estimated 516 –
Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty
pharmaceutical company focused on identifying, developing and
commercializing products for the critical care market, today
provided a detailed clinical progress update for the ongoing
development of its lead candidate levosimendan in cardiac surgery
and septic shock.
LEVO-CTS Trial for Levosimendan in Low Cardiac Output
Syndrome (LCOS)
The Company announced that it has achieved the first milestone
in its ongoing Phase 3 LEVO-CTS trial following the enrollment of
its 200th patient on October 1, 2015. The LEVO-CTS trial is a
double-blind, randomized, placebo-controlled study that is
evaluating the use of levosimendan administered before and during
cardiac surgery to reduce the incidence of low cardiac output
syndrome and associated morbidity and mortality. As of today, 206
patients have been enrolled out of estimated 760 patients.
Tenax also announced that the U.S. Food and Drug Administration
(FDA) has approved its requested protocol amendment for the
LEVO-CTS trial. This amendment changes the inclusion criteria for
the trial to cardiac surgery patients with a left ventricular
ejection fraction (LVEF) of ≤ 35% undergoing a coronary artery
bypass grafting (CABG) procedure, CABG and an aortic valve
procedure, and CABG and/or a mitral valve procedure. Under the
previous protocol, patients undergoing only a CABG procedure were
limited to those with an LVEF of ≤ 25%. In addition, several
entry criteria were clarified to reduce inappropriate patient
exclusions.
The Company believes that this amendment will significantly
increase the potential patient population eligible for enrollment
in the trial.
“With 67 hospitals activated to date, including seven in Canada,
we continue to increase the enrollment rate of the LEVO-CTS trial
and were encouraged to pass the first 200-patient milestone,” said
John Kelley, CEO of Tenax Therapeutics. “We are also pleased that
the FDA has approved our amendment to enroll patients undergoing
CABG procedures with a left ventricular ejection fraction of 35
percent or less. Based on historical clinical results and the
recommendation of our trial steering committee, including
physicians with significant clinical experience using levosimendan,
this broader cardiac surgery patient population should benefit from
our drug candidate. It will also allow us to simplify the
enrollment process and increase the amount of eligible patients for
the study, which we believe will have a significant impact on
enrollment pace as our hospital sites approve the amendment.”
LeoPARDS Trial for Levosimendan in Septic Shock
Today, Tenax also announced that the ongoing LeoPARDS trial
(Levosimendan for the Prevention of Acute oRgan Dysfunction in
Sepsis) conducted by Imperial College London and funded by the UK
Medical Research Council (MRC) and National Institute for Health
Research (NIHR), has enrolled 445 patients out of an estimated
516.
In August 2014, Tenax announced a collaboration with Imperial
College London to provide $500,000 in supplemental funding to
support the accelerated enrollment and completion of the LeoPARDS
study. The trial is designed to determine whether levosimendan
reduces the incidence and severity of acute organ dysfunction in
adult patients who have septic shock, as well as evaluate its
safety profile.
The statistical analysis plan (SAP), with an addendum from
Tenax, was recently submitted to the FDA in follow-up to the
Company’s meeting with the agency in November 2014.
“Our colleagues at Imperial College London continue to make
significant progress with their ongoing LeoPARDS trial, and
enrollment is expected to complete before the end of this calendar
year with data expected in calendar year 2016,” Kelley added.
“Based on our dialogue with the FDA to date, the SAP that includes
additional secondary endpoints around clinically-meaningful
measurements has been submitted to the agency. We look forward to
seeing the results next year, and if positive we believe that these
data would support a regulatory filing.”
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). The Company is currently enrolling
a Phase 3 trial with levosimendan in that indication, and is also
supporting Imperial College London’s ongoing LeoPARDS trial for
levosimendan in septic shock. For more information,
visit www.tenaxthera.com.
About the LeoPARDS Trial for Levosimendan
The LeoPARDS trial is funded by the Efficacy and Mechanism
Evaluation (EME) Programme, an MRC and NIHR partnership. The views
expressed in this publication are those of the author(s) and not
necessarily those of the MRC, NHS, NIHR or the Department of
Health.
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 9, 2015, and annual report on Form 10-K filed on July 14,
2015, 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: http://www.businesswire.com/news/home/20151008005203/en/
Stern Investor RelationsJesse Baumgartner,
212-362-1200jesse@sternir.comorMedia ContactPorter
NovelliChad Hyett, 212-601-8242chad.hyett@porternovelli.com
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