Nymox Pharmaceutical Corp. said its fexapotide triflutate injection helped reduce the risk of disease progression among patients with prostate cancer in a mid-stage study.
The phase 2b study evaluated fexapotide triflutate in 2.5-milligram and 15-milligram doses to treat 146 patients with low grade localized prostate cancer and had Gleason grades of 3+3 or lower. The Gleason score is a grading system used to determine how aggressive the prostate cancer is.
In localized prostate cancer, the cancer is contained within the prostate gland and has not spread to other parts of the body. According to Prostate Cancer U.K., localized prostate cancer often grows slowly or may not grow at all, with a low risk of it spreading.
After 78 months of treatment, patients who received the 15-mg fexapotide experienced a 73% reduction in the need for surgery or radiotherapy associated with Gleason grade progression versus controls. There was also a 65.4% decrease in the instances of surgery or radiotherapy, including elective cases without Gleason upgrades, in the 15-mg patient group.
The company noted that even though both doses were effective overall, the 15-mg dose worked better than the lower dose.
Nymox CEO Paul Averback said in the news release that the company has taken the first steps to meet with regulatory authorities regarding the planned registration trials for low grade prostate cancer.