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Spectral announces results of first interim analysis by Data Safety and Monitoring Board
Enrolment in the EUPHRATES trial is continuing with no safety issues TORONTO, Feb. 4,...
About this update from Spectral Medical Inc
[{"type":"text","content":"\n\n\n\n\n\nEnrolment in the EUPHRATES trial is continuing with no safety issues\n\n\nTORONTO, Feb. 4, 2013 /CNW/ - Spectral Diagnostics Inc. (TSX: SDI) (OTCQX: DIAGF), a Phase III company developing the first theranostic treatment for\n patients with septic shock, today announced that the first interim\n analysis has been conducted on the initial 76 randomized patients in\n its EUPHRATES trial.\n\n\nThe Data Safety and Monitoring Board (DSMB), consisting of experts in\n the fields of critical care medicine, infectious disease, nephrology,\n biostatistics and regulatory affairs, reviewed the totality of the data\n set for evidence of safety concerns, such as adverse events and/or\n adverse device effects, related to the use of the Toraymyxin cartridge.\n\n\nThe results from the first interim safety analysis by the DSMB state\n that there are no safety issues to date concerning the application of\n the Toraymyxin cartridge to patients in the EUPHRATES trial.  In\n addition, the results state that the EUPHRATES clinical protocol\n appears to be defining the correct target patient population for this\n study.\n\n\n\"We are making consistent progress with our pivotal Phase III trial,\"\n said Dr. Paul Walker, Chief Executive Officer of Spectral Diagnostics.\n \"We remain committed to our protocol which randomizes only patients in\n septic shock who are endotoxemic, as they are at greatest risk for a\n poor outcome and therefore most likely to benefit from our theranostic\n approach.\"\n\n\nThere have been 191 patients who have met clinical entry criteria so\n far. As predicted, approximately 50% of these patients have an elevated\n level of endotoxin, which is associated with a high rate of mortality\n in septic shock patients.\n\n\nThe combined 28-day mortality rate remains stable at 35% for patients\n randomized either to the standard of care with SHAM hemoperfusion\n event, or to the Toraymyxin cartridge plus standard of care. This was\n also commented on by the DSMB as a positive sign and provides further\n evidence that the correct patient population is being studied.   For\n those patients with low levels of endotoxin who were not randomized to\n the trial, the 28-day mortality rate is approximately 25% to date.\n\n\nThe DSMB encourages the continued enrolment of patients into the\n EUPHRATES trial.\n\n\nSpectral con...