Phase III studies of NX 1207 (fexapotide triflutate) meet endpoint for benign prostatic hyperplasia- Nymox Pharma

Nymox Pharmaceutical Corp announced that the Company's U.S. long-term extension prospective double-blind Phase III BPH studies NX02-0017 and NX02-0018 of NX 1207 (fexapotide triflutate) for benign prostatic hyperplasia have successfully met the pre-specified primary endpoint of long-term symptomatic statistically significant benefit superior to placebo. Fexapotide showed an excellent safety profile with no evidence of drug-related short-term or long-term toxicity nor any significant related molecular side effects in the 2 studies (n=978).

The primary endpoint variable of the long-term study was improvement in the AUA BPH Symptom Score which was statistically significant (p<.02) in fexapotide-treated patients compared to placebo, at a median duration of 42 months (3.5 years) after a single double-blind injection treatment of fexapotide vs. saline placebo. Median duration of 3.5 years from a single injection treatment mean improvement of 5.3 points in AUA BPH Symptom Score. Statistically significant (mean p<.025; median p<.02) vs saline placebo injection. Mean improvement of 7.1 points in AUA BPH Symptom Score (primary endpoint variable) after median duration of 3.5 years in first-line BPH treatment of fexapotide treated subjects (p<.025 vs placebo).

The Company now intends to meet with authorities and to proceed to file where possible in due course for regulatory approvals for fexapotide triflutate in various jurisdictions and territories.