Nymox Pharmaceutical Corporation announced new positive Phase 3 safety and efficacy data for the company's U.S. study NX02-0020. The NX02-0020 study is a prospective clinical safety evaluation of re-injection of the company's NX-1207 drug for prostate enlargement (benign prostatic hyperplasia or BPH). Study participants consisted of 192 consecutively treated men who had previously participated in the completed NX02-0014 and NX02-0016 Phase 2 trials or in the ongoing NX02-0017 and NX02-0018 trials and who wished an open label injection of NX-1207.

The mean duration from the initial injection to the final assessment was 26 months. Improvement in the American Urological Association BPH Symptom Index Score was assessed over this greater than 2 years period, and the mean overall improvement in the 192 treated men was 7.6 points (p <0.001). Further analyses will be conducted upon the unblinding of NX02-0017 and NX02-0018 trials.

The study has completed its six month primary endpoint of the safety evaluation of NX-1207 re-injection with a positive safety assessment. No significant adverse events related to the drug occurred. NX-1207 treatment for BPH was not associated with the sexual, cardiovascular, or other side effects associated with approved BPH medications.