Tenax Therapeutics Highlights Recent Scientific Publications On Levosimendan
February 2015 publications provide evidence levosimendan may benefit cardiac surgery patients
MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today highlighted two recently-published scientific articles on the potential benefits of its lead candidate, levosimendan, in patients undergoing cardiac surgery.
The company is currently enrolling patients in its Phase 3 LEVO-CTS trial for levosimendan, a double-blind, randomized, placebo-controlled study that will evaluate 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.
“These publications indicate that levosimendan is the best inodilator to improve survival in adult cardiac surgery patients and acts as a ‘safety net’ in this critical care setting,” said John Kelley, CEO of Tenax Therapeutics. “We believe the conclusions drawn in these publications are highly supportive of our LEVO-CTS trial design and expectations regarding our study results.”
The highlighted publications include:
•“Preoperative and perioperative use of levosimendan in cardiac surgery: European expert opinion,” International Journal of Cardiology; Toller, et al. The publication provides a review of the scientific literature as well as consensus recommendations from a panel of 27 experts from 18 countries regarding the preoperative use of levosimendan in cardiac surgery patients. Their recommendations support the LEVO-CTS study design in several ways – specifically, the consensus publication recommends pre-operative dosing and use in low ejection fraction coronary artery bypass and valve surgery patients. Their conclusion also generally supports the LEVO-CTS study endpoints, stating:
“Clinical studies show that levosimendan effectively improves general and pulmonary haemodynamics in patients undergoing cardiac surgery, thereby reducing the need for inotropic agents and mechanical circulatory support, and additionally optimising renal and hepatic function. In general, the length of stay in the ICU and in the hospital is shortened. Overall, levosimendan treatment is considered as a kind of ‘safety net’ in the surgical setting.”
The article was first published online on February 24, 2015, and can be accessed here: http://www.internationaljournalofcardiology.com/article/S0167-5273(15)00149-7/abstract
•“A Bayesian network meta-analysis on the effect of inodilatory agents on mortality,” British Journal of Anaesthesia; Greco, et al. Dr. Greco and his co-authors published the findings of a meta-analysis they conducted to assess differences in mortality associated with various inodilator products that are commonly used in critical care patients. Their study included 46 trials published between 1995-2014 and concluded that levosimendan appears to be the most efficacious inodilator product to improve survival when used in cardiac surgery patients. As stated in their conclusion:
“This manuscript is the most updated and methodologically strongest meta-analysis on the effect of inodilators on mortality in cardiac surgery. Using Bayesian network meta-analyses techniques, we attempted ranking among different inodilators that have never properly been compared one each other, and identified levosimendan to be the best inodilator to improve survival in adult cardiac surgery.”
The article was first published online on February 4, 2015, and the abstract can be accessed here: http://bja.oxfordjournals.org/content/early/2015/02/04/bja.aeu446.abstract
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 is currently enrolling a Phase 3 trial with levosimendan in that indication. 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.
Contacts
Investor Contact
Stern Investor Relations, Inc.
Jesse Baumgartner, 212-362-1200
jesse@sternir.com
or
Media Contact
Porter Novelli
Chad Hyett, 212-601-8242
chad.hyett@porternovelli.com
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MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today highlighted two recently-published scientific articles on the potential benefits of its lead candidate, levosimendan, in patients undergoing cardiac surgery.
The company is currently enrolling patients in its Phase 3 LEVO-CTS trial for levosimendan, a double-blind, randomized, placebo-controlled study that will evaluate 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.
“These publications indicate that levosimendan is the best inodilator to improve survival in adult cardiac surgery patients and acts as a ‘safety net’ in this critical care setting,” said John Kelley, CEO of Tenax Therapeutics. “We believe the conclusions drawn in these publications are highly supportive of our LEVO-CTS trial design and expectations regarding our study results.”
The highlighted publications include:
•“Preoperative and perioperative use of levosimendan in cardiac surgery: European expert opinion,” International Journal of Cardiology; Toller, et al. The publication provides a review of the scientific literature as well as consensus recommendations from a panel of 27 experts from 18 countries regarding the preoperative use of levosimendan in cardiac surgery patients. Their recommendations support the LEVO-CTS study design in several ways – specifically, the consensus publication recommends pre-operative dosing and use in low ejection fraction coronary artery bypass and valve surgery patients. Their conclusion also generally supports the LEVO-CTS study endpoints, stating:
“Clinical studies show that levosimendan effectively improves general and pulmonary haemodynamics in patients undergoing cardiac surgery, thereby reducing the need for inotropic agents and mechanical circulatory support, and additionally optimising renal and hepatic function. In general, the length of stay in the ICU and in the hospital is shortened. Overall, levosimendan treatment is considered as a kind of ‘safety net’ in the surgical setting.”
The article was first published online on February 24, 2015, and can be accessed here: http://www.internationaljournalofcardiology.com/article/S0167-5273(15)00149-7/abstract
•“A Bayesian network meta-analysis on the effect of inodilatory agents on mortality,” British Journal of Anaesthesia; Greco, et al. Dr. Greco and his co-authors published the findings of a meta-analysis they conducted to assess differences in mortality associated with various inodilator products that are commonly used in critical care patients. Their study included 46 trials published between 1995-2014 and concluded that levosimendan appears to be the most efficacious inodilator product to improve survival when used in cardiac surgery patients. As stated in their conclusion:
“This manuscript is the most updated and methodologically strongest meta-analysis on the effect of inodilators on mortality in cardiac surgery. Using Bayesian network meta-analyses techniques, we attempted ranking among different inodilators that have never properly been compared one each other, and identified levosimendan to be the best inodilator to improve survival in adult cardiac surgery.”
The article was first published online on February 4, 2015, and the abstract can be accessed here: http://bja.oxfordjournals.org/content/early/2015/02/04/bja.aeu446.abstract
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 is currently enrolling a Phase 3 trial with levosimendan in that indication. 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.
Contacts
Investor Contact
Stern Investor Relations, Inc.
Jesse Baumgartner, 212-362-1200
jesse@sternir.com
or
Media Contact
Porter Novelli
Chad Hyett, 212-601-8242
chad.hyett@porternovelli.com
Help employers find you! Check out all the jobs and post your resume.