Spectral Achieves Important Milestone in its Pivotal U.S. Clinical Trial for Sepsis
News May 06, 2011
Spectral Diagnostics Inc., has announced that the 15 carefully chosen clinical sites for its EUPHRATES trial are all screening and able to enrol patients.
"The successful enrolment of patients within these outstanding hospitals is indicative of the support for our trial and of the participating clinicians' commitment to our novel trial protocol," said Dr. Paul Walker, CEO of Spectral Diagnostics.
Walker continued, "Once patients have met clinical entry criteria, they are tested using Spectral's EAA™ diagnostic and, then, those shown to be endotoxemic are treated with a targeted therapeutic, Toraymyxin. This is the first time that a theranostics approach has been used in a sepsis trial. Having achieved this significant milestone, we are looking forward to the interim trial results, which we anticipate by the end of the first half of 2012."
EUPHRATES is a randomized, double-blind clinical trial that compares standard of care versus standard of care and Toraymyxin, directed by Spectral's EAA™ Endotoxin Activity Assay. The target population is critically ill patients with septic shock and endotoxemia (as measured by the EAA™). The trial is expected to enroll approximately 360 patients at 15 sites throughout the U.S. and will have a primary end point of 28 day mortality.
Spectral's EUPHRATES trial is the world's first theranostics trial conducted in the area of sepsis. Theranostics, a combination diagnostic and therapeutic, is a novel way of approaching patient care for sepsis. The power of theranostics is the ability to direct a treatment to patients who are both most at risk and most likely to respond to the targeted therapy.
Incorrect patient selection is often considered the cause for the failure of many previous clinical trials in sepsis. In Spectral's EUPHRATES trial, the EAA™ will be used to determine the level of endotoxin in the bloodstream of a patient with septic shock. If EAA™ is elevated (≥ 0.6 EAA™ units), the patient will be eligible for randomization to Toraymyxin plus standard of care, or standard of care alone.
At present, there are few therapeutic treatment options available for the more than 250,000 patients diagnosed with severe sepsis in the U.S. each year. This disease remains a leading cause of mortality.
Toraymyxin has been used safely on more than 80,000 patients worldwide and, when guided by Spectral's EAA™ diagnostic, has the potential to address this large unmet medical need, which is valued at more than $1 billion annually in the U.S.