Nymox Pharmaceutical has reported new positive data from Phase 3 study, designed to evaluate the safety and efficacy of the reinjection of NX-1207 for benign prostatic hyperplasia (BPH).
The NX02-0020 study participants included 192 repeatedly treated men, who were a part of completed NX02-0014 and NX02-0016 Phase 2 trials or taking part in the NX02-0017 and NX02-0018 trials that are still going on.
Nymox CEO Paul Averback said, "This degree of long-term improvement is unprecedented in this condition considering that it is a simple, painless and safe injection with no sexual side effects, and that it has been demonstrated in a large series of treated patients."
Study assessed the improvement in the American Urological Association BPH Symptom Index Score for a period of 26 months, which is the mean duration from drug injection till final evaluation.
NX02-0020 study reported mean overall improvement of 7.6 points, while the company expects to conduct further analysis subsequent to the unblinding of NX02-0017 and NX02-0018 trials.
Positive safety results were obtained for NX-1207 re-injection in the six month primary endpoint, without any related adverse events.