-Trial to continue with a total of 650 patients-
TORONTO, April 14, 2014 /CNW/ - Spectral Diagnostics Inc. (TSX:SDI) (OTCQX: DIAGF) ("Spectral" or the "Company"), a Phase III company developing the first theranostic treatment for patients with septic shock, today announced that the Data Safety Monitoring Board (DSMB) for the EUPHRATES trial has completed its review of the detailed analysis it had previously requested.
Based on the current recommendations of the DSMB, the sample size has been recalculated and increased from 360 to 650 patients.
This increase in the number of enrolled patients enhances the likelihood of demonstrating, with sufficient power, a statistically and clinically significant effect. The revised sample size falls within the statistical plan already agreed to by the United States Food and Drug Administration (FDA). Spectral will also promptly submit a protocol amendment to the FDA, as recommended by the DSMB, for an additional exclusion criterion.
The EUPHRATES trial has continued to enrol patients and, as of April 11, 2014, 271 patients have been randomized.
"We are pleased with the positive outcome of the second interim analysis," said Dr. Paul Walker, President and CEO of Spectral. "The enthusiasm and support from our clinical trial sites has been outstanding. Based on current enrolment rates and number of sites, we anticipate completion of the trial in the first half of 2016."
About Spectral Diagnostics
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostic product for the treatment of severe sepsis and 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 theranostic trial in the area of sepsis.
Toraymyxin has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively on 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 one million patients in the United States are diagnosed with sepsis each year. Approximately one third of these patients progress to severe sepsis and septic shock, representing a significant unmet medical need and a potential market size of approximately $2 billion.
Spectral is listed on the Toronto Stock Exchange under the symbol SDI, and on the OTCQX 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, the ability to manufacture products and supply the market, as well as general economic, market and business conditions, and could differ materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement.
SOURCE: Spectral Diagnostics Inc.
For further information: Anthony Businskas, Executive Vice President and CFO, 416-626-3233 ext. 2200; Adam Peeler, Investor Relations, TMX Equicom, 416-815-0700 ext. 225, firstname.lastname@example.org