Spectral Diagnostics (TSX:SDI, Stock Forum), a Toronto-based firm engaged in the development of diagnostic tests that provide critical information for the early detection of life-threatening diseases, announced today that the company had received notice from the Data Safety Monitoring Board (“DSMB”) that the review and analysis of its EUPHRATES trail was now complete.
According to the news release, the DSMB has upgraded its sample size recommendations from 360 to 650 patients in the company's EUPHRATES trial, the world's first theranostic trial in the area of sepsis.
The sample size increase falls within the statistical plan already agreed upon by the US FDA and is expected to demonstrate in no uncertain terms, a statistically and clinically significant effect.
Company president and CEO, Dr. Paul Walker, commented, “We are pleased with the positive outcome of the second interim analysis. The enthusiasm and support from our clinical trial sites has been outstanding. Based on current enrollment rates and number of sites, we anticipate completion of the trial in the first half of 2016.”
The release went on to note, “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.”
Spectral was in the news recently when the company announced Q4 and year-end 2013 financial results at the end of March.
Shares rose 24.59% on the news to $0.38 per share.
Currently there are 134.5m outstanding shares with a market cap of $51.1 million.