Spectral Diagnostics Inc., has announced the U.S. Food and Drug Administration (FDA) approved the Company's request to add up to an additional 30 clinical trial sites to its Phase III EUPHRATES trial.
The Company's EUPHRATES trial is currently the most innovative Phase III trial in the area of septic shock.
EUPHRATES is a randomized, double-blind controlled, 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's primary endpoint is 28-day mortality.
Spectral now has the capability to expand to a total of 60 clinical sites in North America and internationally. There are currently 22 operational sites. Management anticipates that there will be 40 sites enrolling by the end of this year and the rest, as necessary, in 2013.
Management believes that adding more sites will accelerate the rate of patient enrollment, which should help the Company meet its timelines to receive final data from the trial.
There have been 141 patients who have met the clinical entry criteria, and 54 patients have been randomized into the trial after meeting the biomarker criteria of a high endotoxin level.
The EUPHRATES trial's enrollment rate continues to exceed, on a per-site basis, enrollment rates of previous sepsis trials.
The data and safety monitoring board (DSMB) has indicated that there have been no safety concerns with the trial through five scheduled reviews.
"This is good news for Spectral, its shareholders, and potentially for patients with septic shock," said Dr. Paul Walker, CEO of Spectral Diagnostics.
Dr. Walker continued, "Our eligibility criteria allow us to enroll patients with septic shock who are most likely to benefit from our personalized medicine approach for treatment. We are committed to the pursuit of a life saving product in this group of critically ill patients where the treatments that currently exist only target infection and provide supportive therapy for organ failure."
Spectral's focused approach to patient selection, using a high endotoxin level as entry criteria, has resulted in a composite mortality rate to date of approximately 40%, compared to a predicted composite mortality of 27.5%.
A challenge faced by recent, unsuccessful sepsis trials has been the low rate of placebo mortality, which may make demonstration of benefit difficult.
The EUPHRATES trial to date has a similar composite mortality rate as the EUPHAS trial. The EUPHAS composite mortality rate, as published in the Journal of the American Medical Association in 2009, was 42%.
That trial concluded that 'polymyxin B hemoperfusion added to conventional therapy significantly improved hemodynamics and organ dysfunction and reduced 28-day mortality in a targeted population with severe sepsis and/or septic shock from intra-abdominal gram-negative infections'.
Spectral's interim analysis strategy is currently under review by the FDA and is expected to be finalized in the third quarter.