NYMOX REPORTS RESULTS OF BPH TREATMENT STUDY

Nymox Pharmaceutical has announced positive efficacy and safety results from its recently completed Phase II trial of NX-1207 for benign prostatic hyperplasia (BPH). The trial involved 43 sites in the U.S. and 175 subjects.

The double-blind, placebo-controlled, randomized, parallel-group, three-dose-range study was designed to test safety and efficacy after three months in patients with BPH. Patients were enrolled who had AUA Symptom Score values of greater than or equal to 15 points and prostate volumes of greater than or equal to 40 grams.

Overall, patients treated with NX-1207 showed a total pooled mean improvement of 9.35 points in the primary outcome endpoint of AUA Symptom Score values, which reached statistical significance when compared with the placebo control. The mean improvements in AUA Symptom Score for each of the three doses used in the trial ranged from 8.10 to 11.03 points with statistical significance of p = 0.015 to 0.17.

The results of the trial also demonstrated a good safety and side-effect profile of NX-1207. Subjects treated with the drug had no serious side effects. In particular, patients given NX-1207 had no significant sexual side effects. Serious adverse events occurred in 5.1 percent of all placebo patients and in 0 percent of the NX-1207 group.