"This Analyst Day showcased the highly-regarded physicians and scientists who have significant experience with levosimendan in several indications,” said John Kelley, CEO of Tenax Therapeutics. “The substantial body of clinical experience continues to give us confidence in a positive readout for our LEVO-CTS trial in early 2016. We also eagerly await results from the LeoPARDS trial with our colleagues at Imperial College London to assess whether levosimendan can provide a significant clinical benefit in septic shock, and we plan to provide a statistical analysis plan for that trial to the FDA in the second half of calendar 2015 for evaluation with regard to how the data might support a regulatory filing.”
An archived replay of the audio webcast for the event with presentation slides can be accessed under “Events and Presentations” in the Investors section of the Company’s website at www.tenaxthera.com.
Enrollment Progress Update 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 April 15, 2015, the Company had activated 44 clinical sites and enrolled 58 patients. This compares to 40 sites activated and 41 patients enrolled based on the last update provided on March 18, 2015.
In August 2014, Tenax 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 today, the trial has enrolled 283 out of an estimated 516 patients (www.leopards-trial.org).
Sepsis is a life-threatening condition that causes the blood pressure to fall dangerously, compromising blood flow to vital organs such as the liver and kidney. It is the leading cause for admission to an intensive care unit in the UK, accounting for about 30% of all admissions. Despite advances in treatment around 40% of such patients unfortunately die.
Conventionally, adrenaline-like drugs are used to support a patient’s blood pressure but they can have serious side effects. Levosimendan is a new type of drug that is currently used to treat patients with advanced heart failure. It works in a different manner to adrenaline-like drugs, potentially avoiding some of these side effects. It may also improve the blood flow to vital organs. In small scale clinical trials in patients with sepsis who have been given levosimendan significant improvements were seen in the function of the heart, kidneys and other organs.
Septic shock is a medical condition as a result of severe infection and sepsis, though the microbe may be systemic or localized to a particular site.[1] It can cause multiple organ dysfunction syndrome (formerly known as multiple organ failure) and death.[1] Its most common victims are children, immunocompromised individuals, and the elderly, as their immune systems cannot deal with the infection as effectively as those of healthy adults. Frequently, patients suffering from septic shock are cared for in intensive care units. The mortality rate from septic shock is approximately 25–50%.[1]
