MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today highlighted that Imperial College London has completed enrollment for its LeoPARDS trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis). All 516 patients have now been enrolled, and the presentation of topline data from the study is expected during the first half of calendar year 2016.
“We are very pleased to see the early completion of enrollment for the LeoPARDS trial, which has continued to benefit from our supplemental funding under the collaboration with Imperial College London,” said John Kelley, Chief Executive Officer of Tenax Therapeutics. “We look forward to seeing our UK colleagues present data from their study during the first half of 2016, and if positive continue to expect that these data would support a regulatory filing with the FDA based on the statistical analysis plan that we submitted to the agency earlier this year.”
The LeoPARDS trial is a randomized, double-blind, placebo-controlled, multi-center trial conducted by Imperial College London and funded by the UK Medical Research Council (MRC) and National Institute for Health Research (NIHR). 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 primary endpoint for the study is the mean SOFA score between treatment groups, and secondary endpoints established by Imperial College London include oxygen delivery and cardiac output; incidence and duration of renal failure; serum bilirubin; time to extubation; 28-day, hospital and three- and six-month survival; ICU and hospital length of stay, and ICU-free days; duration of renal replacement therapy; and days free from catecholamine therapy. More information on the trial can be found at www.leopards-trial.org.
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 this trial. Earlier this year, Tenax also submitted a statistical analysis plan (SAP) to the FDA, based on an earlier meeting with the agency, which includes additional secondary endpoints that the Company believes to be clinically meaningful.
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.
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.
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 December 10, 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.