Five-year study of NX 1207 shows cut in surgery or radiotherapy for prostate cancer patients.

Study NX03-0040 was undertaken starting in 2012 at 44 investigational sites across the U.S. comprising a highly representative sample of 146 men with the biopsy confirmed diagnosis of T1c prostate cancer, which is the most common type of low grade localized prostate cancer. After 5 years, the study has now shown that high dose fexapotide 15mg single dosage treatment resulted in 80% less surgery or radiotherapy associated with Gleason grade progression, and that both doses of fexapotide (15mg and 2.5mg) were consistently effective. There were 4.4% patients in the entire fexapotide group who showed increase in their Gleason primary pattern grade in the 5-year study, compared to controls where the incidence of grade 4 or higher primary pattern was 23.5%, a reduction of 81.3%).

After 5 years of study, high dose fexapotide 15mg single treatment resulted in 80% less surgery or radiotherapy associated with Gleason grade progression (p=.0003), and both doses of fexapotide (15mg and 2.5mg) were consistently effective. There were 4.4% patients in the entire fexapotide group who showed increase in their Gleason primary pattern grade in the 5-year study, compared to controls where the incidence of grade 4 or higher primary pattern was 23.5%, a reduction of 81.3%. The new study results also indicated that after 5 years of study, all recorded instances of surgery or radiotherapy, including elective cases without Gleason upgrades, were decreased by 69.8% in fexapotide 15mg treated patients compared to the randomized control group.