Nymox reports 'successful' new study results from Phase 3 trials for fexapotide
Nymox Pharmaceutical is pleased to announce successful new study results from the long-term repeated injection group from the U.S. Phase 3 trials for fexapotide, the Company's lead compound in late stage development for enlarged prostate and for localized prostate cancer. The aim of the study was to determine the safety and clinical benefit fexapotide can provide to men who were given a second injection of fexapotide for their prostate enlargement. In the new study long-term outcomes were determined in 344 patients who were given a single repeat fexapotide treatment after initial blinded treatment with fexapotide or placebo. Patients were followed for 2 to 6.5 years (mean 4.2 years) after initial treatment. All treatment failures were included in the analysis. Results have now shown that there was long-term statistically significant symptomatic improvement (mean improvement of 6.5 points in the AUA BPH Symptom Score) compared to Phase 3 patients who received placebo alone (pless than.001). Repeat injection was found to be safe with no significant drug related toxicities or side effects found in the study.