TORONTO, ONTARIO--(Marketwired - March 10, 2015) - Spectral Medical Inc. ("Spectral" or the "Company") (TSX:EDT)(OTCQX:EDTXF), a Phase III company developing the first treatment for patients with septic shock that comprises a therapeutic device guided by a companion diagnostic, today announced the results of the Data Safety and Monitoring Board (DSMB) recent meeting and its recommendations to Spectral. The DSMB is an independent body of experts in the fields of clinical medicine, biostatistics and trial methodology, which functions via a charter approved by the U.S. Food and Drug Administration (FDA) to review the accumulated data of Spectral's trial and to provide recommendations to the Company on a regular basis.
Key recommendations of recent meeting :
- The DSMB has recommended that the EUPHRATES trial proceed as planned.
- The DSMB has also agreed that an interim analysis be performed on the patients randomized since the last protocol amendment with the amended exclusion criterion.
"We are very encouraged by these recommendations for the EUPHRATES trial," said Dr. Paul Walker, President and CEO of Spectral. "The added exclusion criterion has focused our trial on a sicker group of patients. Clinical studies from Italy and Japan have shown that sicker patients with a higher mortality risk benefit the most from Toraymyxin therapy for endotoxin removal. Our current composite mortality rate suggests that the sample size needed to determine statistical significance could be significantly smaller than previously calculated due to the much higher event rate."
Spectral will now submit an amended statistical analysis plan (SAP) to the FDA incorporating an interim analysis. The SAP will include stopping rules for safety and efficacy. This interim analysis will include only patients enrolled in the trial since implementation of the additional exclusion criterion in April, 2014 up to approximately the end of the third quarter of 2015, with results anticipated to be available late in the fourth quarter of 2015.
About Spectral Medical Inc.
Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment of endotoxemic septic shock. PMX is a therapeutic hemoperfusion device that removes endotoxin, a main trigger of 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 only active and most innovative Phase III study for a medical device in the area of septic shock.
Toraymyxin (PMX) has been approved for therapeutic use in Japan and Europe, and has been used on more than 100,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Approximately 350,000 patients are diagnosed with septic shock in North America each year, representing a greater than $3 billion market opportunity for Spectral.
Spectral is listed on the Toronto Stock Exchange under the symbol EDT, and on the OTC QX under the symbol EDTXF. For more information please visit www.spectraldx.com.
Forward-looking statements
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 commercialization of Spectral's septic shock treatment, 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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