Tenax Therapeutics (TENX) Says Phase 3 LEVO-CTS Trial in Cardiac Surgery Did Not Achieve Dual Endpoint

January 31, 2017 9:03 AM EST

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Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced top-line results from its Phase 3 LEVO-CTS trial. The study did not achieve statistically significant reductions in the dual endpoint of death or use of a mechanical assist device at 30 days, nor in the quad endpoint of death, myocardial infarction, need for dialysis, or use of a mechanical assist device at 30 days. However, the study demonstrated statistically significant reductions in two of three secondary endpoints including reduction in low cardiac output syndrome (LCOS) and a reduction in postoperative use of secondary inotropes. Patient visits for data on death through day 90 have not yet been completed. The Company has a meeting scheduled with the U.S. Food and Drug Administration (FDA) to review the preliminary trial data and discuss a path forward to bring this potentially lifesaving treatment to the benefit of patients undergoing serious cardiac surgery.

“We are disappointed and surprised by the top-line results from this trial, especially given the promising results from earlier published clinical trials. On the other hand, we are encouraged by the statistically significant reduction in incidence of LCOS and use of postoperative secondary inotropes, both of which we believe are clinically important. This is consistent with what we know about how this drug works. In addition, we continue to review the full data set, including the in-process data collection on all-cause mortality through day 90, and will share our complete findings at the upcoming American College of Cardiology (ACC) meeting in March,” said John Kelley, CEO of Tenax Therapeutics. “We thank our clinical collaborators and their patients who participated in this clinical trial with the hope of improving not only their own outcomes, but also the outcomes of future patients undergoing cardiac surgery.”

Analyses of the LEVO-CTS trial results are ongoing and will be presented on Sunday, March 19, 2017, at 8:00 am EDT during a late-breaking clinical trial session at the American College of Cardiology 66th Annual Scientific Session in Washington, D.C.

The full LEVO-CTS trial design was recently published by the study’s investigators in the American Heart Journal in an article titled, “Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery on Cardiopulmonary Bypass: Rationale and Study Design of the LEVO-CTS Trial.

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