Tenax Therapeutics Announces Completion Of Enrollment For Phase 3 LEVO-CTS Trial In Cardiac Surgery

Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that it has completed patient enrollment for its Phase 3 LEVO-CTS trial in cardiac surgery.

The Company will lock its database after 30-day follow-up from the final patient, and currently expects to report top-line results in January 2017 in conjunction with the study's lead investigators at Duke Clinical Research Institute (DCRI).

"We are very pleased to reach this milestone after more than two years of hard work, and would like to thank all of the patients and investigators who have taken part in the trial," said John Kelley, CEO of Tenax Therapeutics. "Consistent clinical execution and increased trial visibility has significantly accelerated the enrollment rate during these past 12 months, and we believe the expanded number of patients ensures that we have the best possible chance for success. We now look forward to sharing top-line results with you during the next few months, and we are prepared for a near-term NDA submission and commercial effort if the data reads out positively. We continue to believe that levosimendan has the potential to fill an important void in the current treatment paradigm for cardiac surgery."

The trial has enrolled a total of 880 patients. This was larger than the original target enrollment number of 760 patients in order to ensure sufficient powering - which was necessary due to a small number of patients who were randomized but did not receive study drug, a small number of patients missing one or more component measurements of the primary endpoint, and a slightly lower primary endpoint event rate than originally projected.

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 (LCOS) and associated morbidity and mortality. The trial is also measuring secondary endpoints around potential pharmacoeconomic benefits and the incidence rate of LCOS. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan in this indication, and agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA).

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