Pathway Forward"Top line results for the Company's pivotal Phase III EUPHRATES trial were announced on October 3, 2016. These results showed that use of the PMX cartridge is safe and demonstrated a five (5) percent reduction in mortality at 28 days in the sickest group of patients (MODS>9) who were treated with two PMX cartridges. This was a pre-specified population which, in addition to a mortality benefit, showed beneficial treatment effects across multiple secondary end points and that the mortality benefit increased as a function of the amount of endotoxin removed.
The EUPHRATES study also showed that endotoxemia remains a major cause of the unacceptably high mortality of patients in septic shock. It is the only trial to have been designed to show the relationship between endotoxemia (based on a reliable method of measurement) and its removal with a cartridge specifically designed to remove endotoxin.
The data base for the EUPHRATES trial contains detailed data on the clinical characteristics of 450 randomized subjects with high levels of endotoxin. These subjects were followed closely over 28 days for changes in endotoxin levels, as well as for other details of the clinical course of their septic shock episode. This extensive data base is now actively being analysed for the effect of endotoxin removal on mortality and on improvement in organ function, including the cardiovascular system. This process is expected be completed and a pre submission meeting held with the FDA by mid-Q1 2017. The Company intends to provide further communication in this regard at that time.
"We are encouraged by the initial trial data and intend to do everything that we can to move this product forward to potential FDA approval. The product is safe and has demonstrated beneficial treatment effects in patients suffering from septic shock, which claims a significant number of lives each year in North America and where no other treatment is available," stated Dr. Paul Walker, President and CEO of Spectral."
https://finance.yahoo.com/news/spectral-announces-next-steps-path-130000971.html