Tenax Therapeutics Announces New Clinical Study Publication Results Indicate Levosimendan Offers Renal Protective Benefits to...
August 28 2018 - 8:30AM
Business Wire
- Results indicate levosimendan increases
glomerular filtration rate (GFR)
- Levosimendan may be a preferred drug
for heart failure patient with impaired renal function
Tenax Therapeutics, Inc. (NASDAQ: TENX) today announced the
results of a new study titled "Differential Effects of Levosimendan
and Dobutamine on Glomerular Filtration Rate in Patients With Heart
Failure and Renal Impairment: A Randomized Double‐Blind Controlled
Trial” were published in the August 21, 2018 issue of the Journal
of the American Heart Association
(https://www.ahajournals.org/doi/full/10.1161/JAHA.117.008455). The
results indicate that levosimendan offers unique renal protective
benefits to patients who have heart failure and coexisting
impairment of their kidney function.
The study authors (Lannemyr, et al) note “this study is the
first evaluating the differential effects of levosimendan and a
catecholamine on measured RBF, GFR, and renal oxygenation in
patients with HF and renal dysfunction.” Renal impairment is a
common comorbidity seen in HF patients and is a strong predictor of
their mortality. This study provides evidence of a mechanistic
explanation for direct renal protective effects that is based on
the unique K-ATP channel mechanism of levosimendan. The findings of
this study are consistent with previous studies that provide
evidence that levosimendan improves GFR and other metrics of renal
function in heart failure patients. These facts contributed to the
authors’ conclusion that levosimendan may be a preferred drug for
heart failure patient with impaired renal function.
The study enrolled 32 patients with HF and renal impairment in a
randomized, double-blind, controlled design and compared the acute
renal and systemic effects of moderate doses of levosimendan (0.1
µg/kg per minute) and dobutamine (7.5µg/kg per minute). Both agents
induced a renal vasodilation and increased RBF to a similar extent.
However, only levosimendan treated patients experienced an increase
in GFR (22%, P=0.012). In contrast, dobutamine treated patients
experienced no improvement in GFR.
Anthony DiTonno, CEO of Tenax Therapeutics, stated “The results
of this new study are encouraging. These findings are consistent
with earlier studies and potentially very relevant to our current
levosimendan clinical development plans in heart failure patients
with pulmonary hypertension and preserved ejection fraction
(PH-HFpEF). Heart failure patients commonly suffer from renal
dysfunction and should benefit from the unique renal protective
benefits that levosimendan appears to provide heart failure
patients, including PH-HFpEF patients with renal impairment.”
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 has a world-class scientific
team including recognized global experts in pulmonary hypertension.
The Company owns the North American rights to develop and
commercialize levosimendan and is in the start-up stage of a 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 the 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 2, 2018,
its quarterly report on Form 10-Q filed on August 14, 2018 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/20180828005089/en/
IRTH CommunicationsRobert Haag,
800-439-1433TENX@irthcommunications.com
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