Replies to post #6952 on Tenax Therapeutics Inc (TENX)

[skyticket1]

pssst back... with your statement you keep calling the FDA , TENX CEO and lead investigator John H. Alexander from Duke (DRCI) a liar and implement that they are misguiding and frauding investors and tax payers money!

if there would be products which help, there would be no LCOS anymore, common sense !

no market for LCOS? talk to the US-families and friends of the victims who suffered and died of LCOS... your comments are not only ignorant they are unethical and misleading....

You suggest that the FDA is wasting time and tax payers money to approve a phase 3-fast track study, you say that the FDA is on purpose misguiding? you seriously believe the FDA does not see the need of such an indication being treated? maybe you should discuss your opinion with the FDA...

LEVO-CTS Phase 3 trial designed to assess the benefits of levosimendan in cardiac surgery patients at risk of developing low cardiac output syndrome (LCOS).

“We are pleased to begin this important Phase 3 study, which has been designed in consultation with leading cardiovascular experts and investigators to provide a clear answer on the potential of levosimendan to prevent complications after high-risk cardiac surgery,” said John Kelley, CEO of Tenax Therapeutics. “We look forward to working with our colleagues at Duke Clinical Research Institute and the other cardiac surgery centers and hospitals involved in the trial, as we continue to activate many additional clinical sites in the months ahead.”

LEVO-CTS is a multi-center, double blind, randomized, placebo-controlled clinical trial that is testing the hypothesis that levosimendan reduces morbidity and mortality in cardiac surgery patients at risk for developing (LCOS). The U.S. Food and Drug Administration (FDA) has already granted Fast Track status for levosimendan in this LCOS indication, and agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA) with guidance that this single successful trial will be sufficient to support approval.

“The LEVO-CTS trial design will test levosimendan in the prevention of LCOS in high-risk patients undergoing cardiac surgery – an area of high unmet medical need and one where several smaller published clinical trials have suggested potential benefit,”[color=red][/color] said lead investigator John H. Alexander, M.D., MHS, Director of Cardiovascular Research, Duke Clinical Research Institute (DCRI). “We are pleased to be getting started with enrollment and are projected to have results in early 2016.”

The LEVO-CTS trial is being led by DCRI and will take place at approximately 50 major cardiac surgery centers in North America. It is seeking to enroll 760 patients undergoing coronary artery bypass graft surgery or mitral valve surgery that are at risk for developing LCOS.

The trial is event-driven, and includes a review of the event rate after the first 200 patients have been randomized in the trial. Two interim analyses will test for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded.

[skyticket1]

LCOS can be considered a form of acute heart failure (AHF). In the same way that AHF produces high mortality in non-surgical patients, LCOS is a major cause of perioperative death in patients undergoing cardiac surgery. LCOS is, however, a peculiar form of AHF as it differs from the latter in etiology, prognosis, and treatment, all of which are influenced by the combination of surgery and anesthesia. Do not compare apples with pears! Abbott went for ADHF (Acute Decompensated Heart Failure)

Although LCOS is not implicated in all deaths after cardiac surgery, it can likely be said to have a part in the majority of deaths. LCOS prolongs the period of invasive monitoring and mechanical ventilation, both of which increase infection rates and are largely responsible for the deterioration in renal functioning. In that sense as well, LCOS' impact on mortality is apparent. In fact, LCOS can be considered a complication of cardiac surgery which directly causes further complications.


Although the general principles for treating AHF apply in the case of LCOS, there are nevertheless some clear differences. Adequate oxygenation should be ensured by using mechanical ventilation and the usual anesthetic care. In surgical patients with low output, hypertension is not present and vasodilatation should be approached with caution in patients who are already usually vasodilated.

Given that contractility is affected by myocardial ischemia stemming from use of an aortic clip, inflammatory response, and some anesthetic drugs, inotropic agents are used in the operating theater and in the immediate postoperative context much earlier and in higher doses that in non-surgical patients. Balloon counterpulsation or mechanical ventricular assistance are also usually used much earlier and more frequently than in non-surgical patients.