Tenax Meets with FDA to Discuss Positive Mortality Data and Potential Levosimendan NDA Submission
May 16 2017 - 4:33PM
Business Wire
Analysis of Pre-Specified LEVO-CTS Subgroup of
Isolated CABG Surgery Patients Indicates a 73% Reduction in 90-Day
All-Cause Mortality (p=0.0016)
Isolated CABG Patients Represented 66% of all
Patients Enrolled in LEVO-CTS Trial
Mortality Reduction in LEVO-CTS Isolated CABG
Patients is Consistent with the Study Hypothesis and Data from
Previously Published Trials
Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty
pharmaceutical company focused on identifying, developing and
commercializing products for the critical care market, today
provided an update on its recent pre-NDA meeting with the FDA.
Tenax met with the FDA on May 10, 2017 to review additional data
analyses from the recently completed Phase 3 LEVO-CTS clinical
study of levosimendan in cardiac surgery patients at risk of LCOS.
The discussion with the FDA built on previously presented primary
data analyses of the LEVO-CTS trial that identified a significant
interaction in levosimendan’s effectiveness across surgery types
enrolled in the study.
The focus of the meeting concentrated on additional analyses of
the 66% of patients in the LEVO-CTS trial who underwent coronary
artery bypass grafting (CABG) alone. In this large prespecified
subgroup of Isolated CABG patients enrolled in the LEVO-CTS trial,
levosimendan treated patients benefited from a highly significant
73% relative risk reduction in all-cause mortality at Day 90, 2.1%
levosimendan vs 7.9% placebo treated patients, (p=0.0016). This
result is consistent with previous Isolated CABG trials (e.g.
Levin, et. al. 2012) which formed the hypothesis for the LEVO-CTS
study. In contrast, levosimendan treated patients who underwent any
type of valve surgery saw a non-statistically significant increase
in 90-day mortality.
In addition to the statistically significant reduction in
mortality in the Isolated CABG subgroup, Tenax also presented data
showing a substantial improvement in post-operative hemodynamics in
Isolated CABG patients treated with levosimendan. These hemodynamic
improvements included highly statistically significant differences
in post-operative cardiac index and reduction in low cardiac output
syndrome in Isolated CABG patients treated with levosimendan vs
placebo. The observed 46% relative risk reduction in the incidence
of low cardiac output syndrome (LCOS) in the LEVO-CTS Isolated CABG
patients treated with levosimendan was highly statistically
significant (p=0.0014). This is a noteworthy finding since LCOS was
a secondary endpoint in the LEVO-CTS trial and patients who
experience LCOS have a much higher incidence of death and
morbidities following cardiac surgery. Similar signs of positive
hemodynamic response were not observed in levosimendan treated
patients undergoing valve surgery in the LEVO-CTS trial.
Tenax also presented support from other published trials of
levosimendan in cardiac surgery and published analyses of results
across studies.
“While the initial top-line results of the LEVO-CTS study were
disappointing, this additional analysis confirmed that CABG only
patients, a prespecified subgroup of the study composing 66% of all
patients enrolled, benefited from statistically significant
reductions in both 30 and 90-day mortality rates, post-operative
cardiac index and incidence of low cardiac output syndrome (LCOS),”
said Michael Jebsen, Interim CEO of Tenax Therapeutics. “We are
encouraged to find the data generated from the LEVO-CTS supports
our continued belief that levosimendan is an effective and safe
inotrope to increase cardiac output in CABG only patients at risk
for developing perioperative low cardiac output syndrome.”
According to data for the Society of Thoracic Surgeons (STS)
National Database, Isolated CABG Surgery patients represent 68% of
all major open heart surgery procedures performed in the US, which
equates to 150,000 to 200,000 patients. An analysis of the Premier
hospital database indicated approximately 38% of Isolated CABG
surgery patients have 2 or more pre-operative risk factors for
LCOS.
As a follow-up to the pre-NDA meeting, the FDA requested
submission of additional information from published cross study
analyses that were presented during the meeting. FDA indicated that
they will provide feedback to Tenax as to whether a levosimendan
NDA for treatment of coronary bypass surgery patients at risk of
LCOS is fileable following their review of the requested
information.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company
focused on identifying, developing and commercializing products for
the critical care market. 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. 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).
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may not demonstrate adequate safety, efficacy or tolerability in
one or more clinical studies for approval by regulatory
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version on businesswire.com: http://www.businesswire.com/news/home/20170516006725/en/
Stern Investor Relations, Inc.Will O‘Connor,
212-362-1200will@sternir.com
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