- Approval includes two interim analyses -
TORONTO, Sept. 26, 2012 /CNW/ - Spectral Diagnostics Inc. (TSX: SDI) (OTCQX: DIAGF), a Phase III company developing the first theranostic treatment for patients with septic shock, today announced that the U.S. Food and Drug Administration has approved an amended protocol for Spectral's EUPHRATES trial, which will now have two planned interim analyses instead of one.
Spectral requested the amendment, including the strategy for two interim analyses, primarily because the composite mortality rate (combined mortality rate for the treated and the placebo groups) for the EUPHRATES trial continues to track at a higher-than-predicted rate (approximately 35% compared to a predicted rate of 27.5%), resulting in a higher-than-anticipated event rate in the trial. The higher composite mortality rate suggests that patients who are most at risk and most likely to benefit from treatment are being randomized into the trial. A higher event rate gives greater statistical power to the trial.
"This is a very positive development for Spectral and, potentially, for patients with septic shock," said Dr. Paul Walker, President and CEO of Spectral. "With an established, steady patient enrolment rate, we are looking forward to the results of both interim analyses, which we expect will provide valuable information to guide the remaining portion of the trial."
The first interim analysis will occur when 76 randomized patients have been followed for 28 days, at which point the DSMB will evaluate and report on the trial's ongoing safety. Management anticipates that, based on the current rate of enrolment, it will disclose the results of that analysis before the end of the first quarter of 2013. To date, 68 patients have been randomized into the trial after meeting both the clinical criteria and the biomarker criteria of a high endotoxin level.
The second interim analysis will occur after 184 randomized patients have been followed for 28 days. At the second analysis, the DSMB will advise Spectral on the trial's safety and efficacy. Stopping rules for efficacy and futility are included in the second interim analysis. A sample size recalculation will be done if necessary. Management anticipates it will disclose information from the second interim analysis in early 2014.
The trial is currently targeted to enroll 306 evaluable patients at up to 60 North American sites. Contingent on maintaining current enrolment rates and timely site start ups, the trial should be fully enrolled by the end of 2014.
EUPHRATES is a randomized, double-blind controlled, clinical trial that compares standard of care versus standard of care and Toraymyxin, directed by Spectral's EAA™ Endotoxin Activity Assay. Spectral's EAA™ is the only FDA-cleared diagnostic for the risk of developing sepsis. The target population for EUPHRATES is critically ill patients with septic shock and endotoxemia (as measured by the EAA™). The trial's primary endpoint is 28-day mortality.
Toraymyxin has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively in more than 100,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin, and in November 2010, signed an exclusive distribution agreement for this product in Canada. More than 250,000 patients are diagnosed with severe sepsis and septic shock in North America each year, representing a greater than $1 billion market opportunity for Spectral.
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of septic shock. Toraymyxin is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA-cleared diagnostic for the risk of developing sepsis, Spectral's EUPHRATES trial is the world's first theranostics trial in the area of sepsis.
Spectral is listed on the Toronto Stock Exchange under the symbol SDI, and on the OTQ QX under the symbol DIAGF. For more information please visit www.spectraldx.com
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
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SOURCE: Spectral Diagnostics Inc.
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