Nymox Pharmaceutical has reported new positive safety and efficacy data from its Phase III repeat injection study, NX02-0020, of NX-1207 for benign prostatic hyperplasia (BPH).
The study, which is designed to assess the clinical safety of drug re-injection, met its six-month primary endpoint with a positive safety profile and no major adverse events.
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Sexual or cardiovascular side effects, which are common in approved BPH medications, were not observed in the study.
The 192 men involved in the study had previously participated in completed Phase II trials or other uncompleted trials of NX-1207.
Nymox CEO Dr 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.”
The study evaluated improvement in the American Urological Association BPH Symptom Index Score over the 26-month period; the mean duration from initial injection to final assessment.
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By GlobalDataThe mean overall improvement was 7.6 points, with further analysis expected after the unblinding of other ongoing NX-1207 trials.
