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Spectral Reaches Enrollment Milestone for its Phase III Euphrates Trial
- Results of the Second Interim Analysis on Track for Q1, 2014 - TORONTO , Sept. 26, ...
About this update from Spectral Medical Inc
[{"type":"text","content":"\n\n\n- Results of the Second Interim Analysis on Track for Q1, 2014 -\n\n\nTORONTO, Sept. 26, 2013 /CNW/ - Spectral Diagnostics Inc. (TSX:SDI) (OTCQX:DIAGF) (\"Spectral\" or the \"Company\"), a Phase III company developing the first\n theranostic treatment for patients with severe sepsis and septic shock,\n today announced that the 184 patients required for the planned, second\n interim analysis have been randomized into its EUPHRATES trial. After\n the randomized patients have been followed for 28 days, all data will\n be accumulated and analyzed.\n\n\nThe Data Safety Monitoring Board (DSMB) will then review the data and\n report to the Sponsor, which is expected to occur in early 2014. The\n DSMB will review the overall progress of the trial and advise Spectral\n on the trial's safety, futility and efficacy, with stopping rules in\n place for efficacy. If necessary, a sample size recalculation will then\n be performed.\n\n\nThe current composite 28-day mortality rate of 33 percent for randomized\n patients in the trial continues to suggest that the trial is enrolling\n patients who are at greatest risk for a poor medical outcome and,\n therefore, would most likely benefit from the Company's theranostic\n treatment.\n\n\n\"We are looking forward to the outcome of the second interim analyses,\n which we anticipate will allow Spectral to plan for the successful\n completion of the EUPHRATES trial,\" said Dr. Paul Walker, President and\n CEO of Spectral. \"All indications suggest that we are enrolling the\n appropriate patients for this trial.\"\n\n\n\"The dedication of our clinical sites and staff has allowed us to reach\n the 184 randomized patients almost one quarter ahead of this year's\n prediction,\" said Ms. Debra Foster, Spectral's Vice President of\n Clinical Development. \"The trial is currently enrolling patients at 44\n sites, operating in 49 hospitals in North America, at a consistent and\n robust rate.\"\n\n\nAbout Spectral Diagnostics\n\n\nSpectral is a Phase III company seeking U.S. FDA approval for its lead\n theranostic product for the treatment of severe sepsis and septic\n shock. Toraymyxin is a therapeutic hemoperfusion device that removes\n endotoxin, which can cause sepsis, from the bloodstream. Directed by\n the Company's Endotoxin Activity Assay (EAA™), the only FDA-cleared\n diagnostic for the ris...