Dr. Paul Walker reports

LARGEST JAPANESE REGISTRY DATA ANALYSIS DEMONSTRATES SIGNIFICANT REDUCTION IN MORTALITY RATE OF SEPTIC PATIENTS TREATED WITH TORAYMYXIN

Spectral Diagnostics Inc. has provided an update. The largest-ever analysis of Japanese registry data on the significant mortality rate reduction in patients with septic shock treated with Toraymyxin has been presented at the American Society of Nephrology. The results of the study and analysis support Spectral's Euphrates trial design.

The study, conducted by Dr. M. Iwagami of the University of Tokyo in Japan and supported by the Japanese government, reviewed the Japanese Diagnosis Procedure Combination Database (based on the ICD-10 international classification) and compared 1,116 patients with septic shock treated with PMX who also received continuous renal replacement therapy to 1,115 patients with septic shock who were treated with CRRT only. CRRT is a form of dialysis reserved for some of the sickest patients in intensive care units.

The mortality rate of patients treated with two PMX cartridges was 34.5 per cent compared with 47.0 per cent in the untreated group, representing an approximate 25-per-cent relative reduction in mortality at 28 days. The authors contrasted these results with those of a study they had conducted one year earlier, in which they evaluated the effect of PMX treatment on a cohort of less severe septic patients and found little difference in survival rates between the treated and untreated groups. The authors concluded, in their presentation at the American Society of Nephrology, that PMX therapy is most effective in patients at the highest risk of death. Furthermore, they noted that those patients who were treated with two PMX cartridges demonstrated a more meaningful benefit versus those treated with only one cartridge. This is the same treatment methodology used in the Euphrates trial.

"The results of this very large analysis support our Euphrates trial design wherein only the most severe septic shock patients (organ failure score greater than 9) are eligible for randomization into the trial. These are the patients with the highest risk of death from septic shock and this analysis emphasizes the benefit of PMX in high risk groups," noted Dr. Paul Walker, president and chief executive officer of Spectral. "Furthermore, the analysis clearly shows a significant reduction in mortality of patients with septic shock using the same two-cartridge-treatment methodology as in our trial."

We seek Safe Harbor.