Oxygen Biotherapeutics Inc. a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, announced a collaboration with Imperial College London to provide supplemental funding to support the accelerated enrollment and completion of the ongoing LeoPARDS Trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis) awarded by the Efficacy and Mechanism Evaluation (EME) Programme and funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership. Oxygen is also currently preparing to initiate a Phase 3 trial in the United States during the third quarter to evaluate levosimendan in cardiac surgery patients at risk of developing low cardiac output syndrome (LCOS).

 

The LeoPARDS trial is designed to determine whether levosimendan reduces the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as evaluate its safety profile. Septic shock represents an area of very high unmet medical need, as the condition is associated with high mortality, morbidity and critical care costs. Given the limited treatment options that exist and the prior research data regarding the potential benefits of levosimendan in septic shock patients, the EME Program awarded funding of the LeoPARDS trial, which will be led by Imperial College London.

 

“Early preclinical and clinical studies of levosimendan have demonstrated potentially unique beneficial effects on heart performance and organ perfusion in patients suffering from septic shock, with a differentiated mechanism that could avoid the pitfalls of commonly used adrenaline-like drugs,” said Dr. Anthony Gordon, chief investigator of the LeoPARDS trial and a critical care physician and septic shock expert at Imperial College London. “We are grateful to have the additional support from Oxygen Biotherpaeutics, a leader in the continued development of levosimendan, to help us accelerate trial enrollment as we work toward providing these patients with additional therapeutic options.”

 

“We are very pleased to support the LeoPARDS trial and to accelerate the timeline for results from this important study in septic shock patients,” said John Kelley, CEO of Oxygen Biotherapeutics. “Past clinical trials indicate that levosimendan may offer septic shock patients important clinical benefits, and our collaboration with Imperial College London on this trial is just one example of how we intend to utilize the significant European clinical experience with levosimendan across a wide range of critical care conditions to guide our development strategy in the United States. While our focus remains on our upcoming Phase 3 trial in cardiac surgery patients at risk of developing LCOS, we are currently monitoring a number of ongoing trials that are designed to evaluate levosimendan in indications such as high risk non-cardiac surgery, acute kidney injury, and acute respiratory failure, which could all represent attractive areas for further development to help patients with critical care conditions of high unmet need.”

 

The LeoPARDS trial began patient enrollment in the first quarter of 2014 with significant interest and trial enrollment, but the existing funding meant several interested clinical trial sites were unable to participate. Oxygen has agreed to provide supplemental funding of $500,000 through an unrestricted grant, which will allow additional sites to enroll patients more quickly.

 

The randomized, double-blind, placebo-controlled, multi-center trial design is based on previously conducted small clinical trials which indicate that levosimendan may provide unique and important clinical benefits to septic shock patients through improved heart function and organ perfusion. 

 

Date: August 6, 2014

Source: Oxygen Biotherapeutics