Phase III results with NX 1207 (fexapotide) shows safety and efficacy in prostate cancer- Nymox Pharmaceutical Corp

Nymox Pharmaceutical Corp has announced major progress in the evidence for the safety and efficacy of NX 1207 (fexapotide), the Company's Phase III drug in the final stages of development for prostate enlargement (BPH) and for low grade prostate cancer. Fexapotide has completed 2 long-term large Phase III BPH studies? in the U.S. No other new prostate drug injectable currently in development has previously succeeded in enrolling and completing a fully U.S. study close to the size of either of Nymox�s 2 long-term studies. In addition, no other injectable prostate enlargement drug has previously been shown to have the excellent long-term safety and efficacy profile of fexapotide.

Fexapotide treated BPH patients were shown to have a remarkably low incidence of ?later development of prostate cancer after up to 7 years of follow-up at top U.S. clinical trial centers. The incidence rate was 1.3% which is a long-term finding of major significance for the drug safety and efficacy. By comparison, for example in a population of patients with erectile dysfunction treated with PDE5 inhibitor drugs after 4 years the rate of subsequent prostate cancer was 19.5% (and 22.7% in controls) as recently reported in a large U.S. study published in the Journal of Urology (Volume 196; 3, 2016). The quoted study was in a population of middle aged and elderly men without prostate cancer, similar to the Nymox study population.

Comment: Fexapotide will be filed for approval in the next 1-2 quarters and the company envisages no significant new cash needs ?for the pre-marketing development of fexapotide. The drug will potentially be partnered for marketing with a larger company if satisfactory terms can be negotiated.