REC 0482 (fexapotide) shows efficacy in phase III trial for Benign Prostatic Hyperplasia - Nymox Pharmaceutical

Nymox Pharmaceutical has announced successful new study results from the long-term repeated injection group from the U.S. Phase III trials for REC 0482 (fexapotide), the Company's lead compound in late stage development for enlarged prostate (BPH) 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 (BPH).

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 III patients who received placebo alone. Repeat injection was found to be safe with no significant drug related toxicities or side effects found in the study.

Nymox has completed and fully financed the execution of seven Phase III U.S. BPH clinical protocols, including 2 prospective randomized multicenter single injection double blind clinical trials; 2 U.S. repeat injection clinical trials; and 3 U.S. blinded long-term clinical trial extension studies. In addition, a number of Phase III safety and clinical pharmacology studies and analyses have been completed. The Company expects to file for approvals in the next 1-2 quarters. The Company also expects to report further analyses and results when available in the near future.