Spectral Diagnostics Inc. has announced that the first interim analysis has been conducted on the initial 76 randomized patients in its EUPHRATES trial.
The Data Safety and Monitoring Board (DSMB), consisting of experts in the fields of critical care medicine, infectious disease, nephrology, biostatistics and regulatory affairs, reviewed the totality of the data set for evidence of safety concerns, such as adverse events and/or adverse device effects, related to the use of the Toraymyxin cartridge.
The results from the first interim safety analysis by the DSMB state that there are no safety issues to date concerning the application of the Toraymyxin cartridge to patients in the EUPHRATES trial.
In addition, the results state that the EUPHRATES clinical protocol appears to be defining the correct target patient population for this study.
"We are making consistent progress with our pivotal Phase III trial," said Dr. Paul Walker, Chief Executive Officer of Spectral Diagnostics.
Dr. Walker continued, "We remain committed to our protocol which randomizes only patients in septic shock who are endotoxemic, as they are at greatest risk for a poor outcome and therefore most likely to benefit from our theranostic approach."
There have been 191 patients who have met clinical entry criteria so far. As predicted, approximately 50% of these patients have an elevated level of endotoxin, which is associated with a high rate of mortality in septic shock patients.
The combined 28-day mortality rate remains stable at 35% for patients randomized either to the standard of care with SHAM hemoperfusion event, or to the Toraymyxin cartridge plus standard of care.
This was also commented on by the DSMB as a positive sign and provides further evidence that the correct patient population is being studied.
For those patients with low levels of endotoxin who were not randomized to the trial, the 28-day mortality rate is approximately 25% to date.
The DSMB encourages the continued enrolment of patients into the EUPHRATES trial.
Spectral continues to initiate new sites to the EUPHRATES trial in Canada and the United States. The Company anticipates that it will have 45-50 sites enrolling patients by the end of June, 2013.
Spectral remains on track to achieve the trial's next milestone, which will be a second planned interim analysis after 184 randomized patients have been followed for 28 days.
At the second analysis, the DSMB will advise Spectral on the trial's safety, efficacy or futility, with stopping rules in place for efficacy and futility.
A sample size recalculation will be done if necessary. Management expects to disclose information from the second interim analysis in the first half of 2014.