Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced the appointment of Paula Bokesch, M.D. as Chief Medical Officer, effective February 14, 2015. In addition, Tenax announced positive enrollment progress for the ongoing late-stage trials for levosimendan.

Dr. Bokesch will direct clinical development for the Company’s lead asset, levosimendan, including the current Phase 3 LEVO-CTS trial to evaluate the use of levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS).

“We are very pleased to welcome Dr. Bokesch to Tenax Therapeutics as we advance late-stage clinical development of our levosimendan program,” said John Kelley, Chief Executive Officer of Tenax. “With an extensive background in critical care drug development at multiple companies, along with experience as a practicing pediatric cardiac anesthesiologist, Dr. Bokesch is the ideal choice to lead our clinical program as we continue with our ongoing Phase 3 trial in LCOS, consider an expansion into septic shock, and evaluate additional pipeline opportunities.”

Dr. Bokesch has more than 10 years of drug development experience in acute and critical care indications. Most recently she worked for 5 years as a Senior Medical Director for Drug Development at Cubist Pharmaceuticals, where she served within the Company’s programs for Daptomycin, pain, acute/critical care and antibiotics. Dr. Bokesch also served as Global Medical Director for Hospira, where she worked in Medical Affairs and Drug Development within the Precedex and acute/critical care programs. She is also a practicing anesthesiologist at St. Elizabeth’s Hospital in Boston, as well as an Affiliate Assistant Professor at Tufts School of Medicine. Dr. Bokesch holds an M.D. from the Bowman Gray School of Medicine at Wake Forest University.

“I am very excited to be joining Tenax Therapeutics at a significant time for the company, with an ongoing late-stage study in an important critical care indication with unmet medical needs,” Dr. Bokesch said. “Levosimendan has shown compelling data in the cardiovascular area and potential in a range of additional indications with limited treatment options, such as septic shock, and I look forward to working with the team here as we execute on our development plan and continue to broaden our pipeline.”

Enrollment Progress On Track for LEVO-CTS and LeoPARDS Trials

Today, Tenax also provided an enrollment update for its ongoing Phase 3 LEVO-CTS trial in LCOS. As of February 2, 2015, the Company had activated 33 clinical sites and enrolled 25 patients. This compares to 21 sites activated and 14 patients enrolled based on the last update provided on December 17, 2014. The Company is now two-thirds of the way to its goal of 50 activated sites in the U.S. by the end of March 2015.

In August 2014, the Company entered into a strategic collaboration with Imperial College London to provide supplemental funding for the ongoing LeoPARDS trial being conducted for levosimendan in septic shock in the United Kingdom. As of February 2, 2015, the trial had enrolled 201 out of an estimated 516 patients (www.leopards-trial.org). On December 17, 2014, the trial had enrolled 150 patients.

“We are very encouraged by the increased enrollment rate for our Phase 3 LEVO-CTS trial as we continue to bring more sites on-line, with a goal of 50 active hospitals by the end of the first calendar quarter of 2015,” Kelley said. “Meanwhile, the enrollment of the LeoPARDS trial in septic shock continues to accelerate. We view levosimendan as having important potential in this indication and recently discussed a potential development plan with the U.S. Food and Drug Administration during the fourth calendar quarter of 2014. The results of the LeoPARDS trial will help inform that potential path, and we look forward to seeing these results together with our collaborators at Imperial College London.”

About Tenax Therapeutics

Tenax Therapeutics, Inc. (formerly Oxygen Biotherapeutics) is a specialty pharmaceutical company focused on developing and commercializing a portfolio of 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 initiated a Phase 3 trial with levosimendan in that indication in July 2014. 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 15, 2014 and annual report on Form 10-K filed on July 29, 2014, 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.


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