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Tenax Therapeutics Announces Plan to Develop Levosimendan for a Pulmonary Hypertension Indication with No FDA Approved Therapies

January 16, 2018 -- Tenax Therapeutics, Inc. (NASDAQ: TENX) today announced plans to advance the development of levosimendan for the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF). PH-HFpEF is a common condition with a poor outcome (5 year survival less than 50%). Given that no therapies are approved to treat an estimated 1.5 million patients who suffer from this condition, it represents a disease with high unmet medical need. Tenax plans to initiate a Phase 2 trial in PH-HFpEF patients in the early part of the third quarter of 2018.

Based on strong feedback from multiple experts in the field of PH-HFpEF, Tenax believes that PH-HFpEF represents a very attractive area for Levosimendan clinical development. Several compelling reasons to pursue development in pulmonary hypertension include:

  • Positive Levosimendan Data - Preliminary studies of favorable drug effects in patients with pulmonary hypertension
  • High Unmet Need - No drugs are approved for the treatment of PH-HFpEF
  • Large Population - Estimated US Prevalence PH-HFpEF exceeds 1.5 million patients
  • High Value Chronic Therapy - Unique long-lasting drug effects allow for chronic intermittent therapy
  • Efficient Clinical Development Plan - A single Phase 2 trial designed to establish the benefits of levosimendan in PH-HFpEF patients

A group of globally recognized pulmonary hypertension and HFpEF experts have helped advise Tenax on this new development opportunity. One of Tenax’s advisors, Stuart Rich, MD, Director of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute stated, “PH-HFpEF is a serious public health problem that is becoming a common cause of pulmonary hypertension for which there are no effective treatments. The novel mechanisms of action of Levosimendan, supported by published data from trials in pulmonary hypertension, as well as left and right ventricular failure, provide a strong rationale for the development of Levosimendan in PH-HFpEF.” Michael Jebsen, Interim CEO of Tenax Therapeutics said, “We are very appreciative of the advice and expertise that Dr. Rich and our other clinical advisors have provided us regarding this new opportunity. Our advisors’ strong support for this development plan, combined with the significant commercial value that it could represent, makes us very excited to execute this new clinical development strategy.”

A pre-IND Meeting is scheduled with FDA to discuss development of levosimendan in PH-HFpEF in the coming months. In parallel, the Company will continue to work with its advisors to initiate the Phase 2 clinical trial in the third quarter of 2018.

About Levosimendan

Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.

About Tenax Therapeutics

Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on licensing, development, and commercialization of drugs that address conditions with high unmet medical need. The Company has a world-class scientific team including recognized global experts in pulmonary hypertension. The Company owns the North American rights to develop and commercialize Levosimendan. 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 annual report on Form 10-K filed on March 16, 2017, its quarterly report on Form 10-Q filed on November 9, 2017 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.

Source: Tenax Therapeutics, Inc.

Posted: January 2018

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