MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today highlighted a newly-published scientific article on the potential benefits of its lead candidate levosimendan for the treatment of severe sepsis and septic shock in comparison to standard inotropic therapy.
The Company currently collaborates with Imperial College London to support the accelerated enrollment and completion of the ongoing LeoPARDS trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis). This project 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.
The LeoPARDS trial is designed to test the use of levosimendan to reduce the incidence and severity of acute organ dysfunction in adult septic shock patients, as well as to evaluate its safety profile. As of June 9, 2015, the trial had enrolled 340 out of an estimated 516 patients, with data expected in calendar year 2016.
“We are encouraged by this recent publication, which we believe shows the potential of levosimendan as a treatment option for septic shock patients who continue to suffer from a severe lack of effective therapy options,” said John Kelley, Chief Executive Officer of Tenax Therapeutics. “We continue to work with our colleagues at Imperial College London as they enroll the LeoPARDS trial, and expect to receive further guidance from the U.S. Food and Drug Administration this year with regard to a statistical analysis plan for this study and how the data might be analyzed to support a regulatory filing.”
The article, titled “Levosimendan reduces mortality in severe sepsis and septic shock patients: a meta-analysis of randomized trials,” was recently accepted in the Journal of Critical Care from Zangrillo, et al. It was first published online on May 29, 2015, and a reference link to the abstract is provided here: http://www.sciencedirect.com/science/article/pii/S0883944115003196
The paper examines pertinent randomized trials from existing academic publications and analyzes the pooled results to establish a primary outcome measure in mortality, alongside additional secondary outcomes. Seven existing studies with 246 total patients were included in the meta-analysis, with a levosimendan group compared to patients using standard inotropic therapy (primarily dobutamine).
The paper concludes that: “In patients with severe sepsis and septic shock, levosimendan is associated with a significant reduction in mortality compared with standard inotropic therapy. A large ongoing multicenter randomized trial will have to confirm these findings.”
Of patients treated in the meta-analysis, the levosimendan group showed a mortality rate of 47% (59 out of 125) in comparison to 61% in the standard inotropic therapy group (74 out of 121). Among secondary outcomes, levosimendan was also associated with a significant reduction in blood lactate, as well as higher cardiac index (CI).
“This meta-analysis provides important insights into the potential benefits of levosimendan in septic shock, and the findings merit extended study in a larger trial setting,” said Giovanni Landoni, M.D., Professor at Vita-Salute San Raffaele University of Milan, Italy, and corresponding author on the paper. “As noted in the publication, the upcoming data from the LeoPARDS trial would provide us with a much larger randomized controlled study which could potentially support the conclusions drawn in this paper.”
Septic shock is a critical care condition with severe unmet needs that causes blood pressure to fall dangerously, which can compromise blood flow to vital organs such as the liver and kidney. As many as 500,000 patients suffer from the condition in the United States, with an estimated mortality rate as high as 50%.
Current standard therapy involves adrenaline-like drugs used to support blood pressure with significant side effects. Levosimendan’s unique mechanism of action suggests the potential to avoid these side effects and improve patient outcomes – particularly by increasing cardiac performance with low energy expenditure and possible improved organ protection effects.
“We find the data from this analysis very encouraging and supportive of our ongoing LeoPARDS trial for levosimendan in septic shock,” said Anthony Gordon, M.D., Clinical Senior Lecturer and Consultant in Critical Care Medicine at Imperial College London, and chief investigator of the LeoPARDS trial. “We continue to anxiously await the results of this larger, randomized study and look forward to seeing data upon enrollment completion next year.”
About Tenax Therapeutics
Tenax Therapeutics, Inc., 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 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 NHS and the National Institute for Health Research
1. The project is managed by the Efficacy and Mechanism Evaluation Programme, an MRC and NIHR partnership, that supports later-phase “science-driven” clinical trials and evaluative studies, which seek to determine whether a health intervention (e.g. a drug, diagnostic technique or device) works and in some cases how or why it works. The programme is funded by the MRC and NIHR, with contributions from the CSO in Scotland, NISCHR in Wales and the HSC R&D Division, Public Health Agency in Northern Ireland. www.nets.nihr.ac.uk/programmes/eme
2. The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk).
3. The Medical Research Council has been at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers’ money in some of the best medical research in the world across every area of health. Twenty-nine MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. www.mrc.ac.uk
This article presents independent research supported by an MRC and NIHR partnership. The views expressed are those of the author(s) and not necessarily those of the NHS, the MRC, the NIHR or the Department of Health.
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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 March 17, 2015 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.