Nymox Announces Prostate Drug Progress

HASBROUCK HEIGHTS, N.J., Aug. 11, 2016  -- Nymox Pharmaceutical Corporation (NYMX) is pleased to announce major progress in the evidence for the safety and efficacy of fexapotide, the Company's Phase 3 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 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." 

 

For more information please contact This email address is being protected from spambots. You need JavaScript enabled to view it. or 800-936-9669.

 

Forward Looking Statements

 

To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for fexapotide. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox's regulatory filings, Nymox's substantial dependence on fexapotide, Nymox's commercialization plans and efforts and other matters that could affect the availability or commercial potential of fexapotide. Nymox undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox's current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2015, and its Quarterly Reports.