Business
Spectral announces second quarter 2013 results
TORONTO , Aug. 13, 2013 /CNW/ - Spectral Diagnostics Inc., (TSX:SDI) (OTCQX: DIAGF) , a...
About this update from Spectral Medical Inc
[{"type":"text","content":"\n\n\nTORONTO, Aug. 13, 2013 /CNW/ - Spectral Diagnostics Inc., (TSX:SDI) (OTCQX: DIAGF), a Phase III company developing the first theranostic treatment for\n patients with severe sepsis and septic shock, today announced its\n unaudited financial results for the second quarter ended June 30, 2013.\n\n\nSecond Quarter Highlights:\n\n\nEnrolled patients into the Company's Phase III EUPHRATES trial at an\n accelerated rate compared to the prior year. Directed by the Company's\n Endotoxin Activity Assay (EAA™), which is the only FDA-cleared\n diagnostic for the risk of developing sepsis, Spectral's EUPHRATES\n trial is targeted to enroll 306 evaluable patients. Contingent on\n maintaining current enrollment rates and timely site start ups, the\n trial should be fully enrolled in the second half of 2014. As of August\n 12, 2013, 159 patients have been randomized into Spectral's EUPHRATES\n trial.\n\nAnnounced the appointment of Dr. Gualtiero Guadagni as the Company's\n Vice President, Sales and Marketing. Dr. Guadagni will primarily be\n responsible for the development and expansion of commercial activities\n and market preparation plans for Toraymyxin and Spectral's Endotoxin\n Activity Assay (EAA™) in Canada, the United States and Europe.\n\nClosed a private placement for gross proceeds of $5.6 million.\n\nConcluded the reporting period with approximately $10.6 million in cash,\n cash equivalents and short-term investments.\n\nSubsequent to quarter end, disclosed that the trial's composite 28-day\n mortality rate was approximately 33 per cent for randomized patients.\n The composite mortality rate continues to suggest that the Company is\n enrolling patients who are most likely to benefit from Spectral's\n treatment.\n\n\n\"We made excellent progress with the trial's patient enrollment in the\n second quarter, which moves us closer to the study's planned, second\n interim analysis,\" stated Dr. Paul Walker, President and CEO of\n Spectral. \"We are optimistic that the results from the second interim\n analysis should support the successful completion of the trial.\"\n\n\nAt the second interim analysis, the Data and Safety Monitoring Board\n will advise the Company on the trial's safety, efficacy or futility,\n with stopping rules in place for efficacy and futility. A sample size\n recalculation will be done if necessa...