Spectral Diagnostics Inc. has announced an update on its ongoing EUPHRATES trial.
On January 27, 2014, the Data Safety Monitoring Board ("DSMB") met to review the results of the second interim analysis after 184 patients had been randomized and followed for 28 days in accordance with the Statistical Analysis Plan agreed to with the FDA.
On that date, the DSMB reported that stopping rules for safety, efficacy and futility were not met and that the trial should continue. The DSMB did not, however, provide the planned sample size recalculation at that time.
The DSMB requested that additional analysis be performed by the Contract Research Organization on the original 184 patients prior to the recalculation. This analysis is ongoing and is expected to take several more weeks to complete. In the meantime, the enrollment in EUPHRATES continues with currently 256 patients randomized.
Spectral has scheduled the next quarterly DSMB meeting for early April 2014, at which time it expects to receive the recommendations of the DSMB based on its review of the requested detailed analysis, as well as data from additional patients enrolled since the 184 patient cut off for the second interim analysis.
A sample size recalculation is expected to be performed and reported to the Sponsor, as well as any other recommendations.
The EUPHRATES trial was designed to show a benefit in mortality between the treated group and the control group of between 10% to 15% at a power of eighty percent.
The original sample size of 360 enrolled patients would be required to show a 15% benefit in mortality, while demonstrating a 10% difference could require up to approximately 700 patients.
The Company expects to announce its clinical pathway forward after receiving and evaluating the DSMB recommendations.