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 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.