Nymox unveils major progress in evidence for efficacy of prostate drug

Fexapotide has completed 2 long-term large Phase 3 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.

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.

While there are other companies with early stage drug candidates and/or drugs with questionable results and worrisome safety issues such as immunological reactions and common danger signs such as frequent injection related fevers, Nymox has none of these problems and considers there to be no competition for at least the next 5-10 years in this field because of the long times required to catch up to Nymox.

Another reason some potential competitors may fail is if they are developing a biological, because this therapeutic market is unlikely to support a drug which costs thousands of dollars per dose to manufacture‎. Nymox has solved the above problems and fexapotide is a drug with low manufacture cost, high projected profit margin, and no known danger signs such as listed above.

Most importantly, the drug has completed 2 U.S. long-term studies which have taken 7 years to complete and no competitor has completed even their first fully U.S. study and therefore the field is at least 5-10 years behind.

Nymox also completed a 147 patient prospective controlled prostate cancer study for low grade localized cancer. After 18 months the fexapotide treated groups had statistically significant better outcomes in terms of cancer progression than controls.

While some injectable candidates at other companies have reported anecdotal results in two or three patients, Nymox found similar or better results than the latter anecdotal reports even in its untreated study controls.

The Company considers that in this category there is no other proprietary new injectable that has yet been through a large clinical trial with any demonstrated efficacy.

Nymox CEO Dr. Paul Averback commented "Our extremely low cash requirements and strong, comprehensive successful clinical trial results add up to a very strong position for the Company's future. In this context we furthermore look forward to reporting in the very near future on some additional new clinical trial results for fexapotide."