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 an update for its ongoing Phase 3 LEVO-CTS trial for lead candidate levosimendan in cardiac surgery.
The Company announced that the independent Data and Safety Monitoring Board (DSMB) for LEVO-CTS has completed its review of the first 254 patients enrolled in the trial and recommended that Tenax continue with the trial as planned without any alterations. The DSMB recommendation is primarily based on a review for any potential safety signal in the study. The DSMB will next review data on the first 400 patients enrolled in the trial and conduct the first interim analysis. The second interim analysis is planned when 600 patients have been enrolled.
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. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan in this indication and agreed to the trial design under Special Protocol Assessment (SPA).
The Company also announced that as of today, 388 patients have been enrolled out of an estimated 760 total patients – showing a marked increase in enrollment rate after previously reporting 301 patients enrolled as of December 15, 2015. In the month of January, 63 patients were enrolled in the trial, surpassing the previous monthly high of 44 patients. Tenax still expects to report topline data near the end of calendar year 2016.
“We are pleased that the DSMB has recommended that we continue moving ahead with this trial, and we are very encouraged by the rapid increase in enrollment during the past several months,” said John Kelley, CEO of Tenax Therapeutics. “With our previous protocol amendment in place and many sites starting to consistently enroll more patients on a weekly basis, we hope to continue this positive trend and look forward to seeing topline results near the end of this calendar year as we work to bring levosimendan to cardiac surgery patients still suffering from severe unmet needs and complications.”
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 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 12, 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.