Nymox Reports Successful New Long-Term Fexapotide Placebo Crossover Study Results: Major Reduction in Incidence of Surgery

HASBROUCK HEIGHTS, N.J., Aug. 24, 2016 -- Nymox Pharmaceutical Corporation (NYMX) is pleased to announce successful new study results from the long-term blinded placebo crossover group from the U.S. Phase 3 trials for fexapotide, the Company's lead compound in late stage development for enlarged prostate (BPH) and for localized prostate cancer. The aim of the study was to determine the clinical benefit fexapotide can provide to men who initially were double blind randomized to and received placebo, remained blinded as to their placebo treatment, and who subsequently required additional medical and/or surgical treatment. In the new study long-term outcomes were determined in 391 patients who were given double blind placebo injections, which were followed by crossover to other treatments at the patients' discretion. The numbers of blinded placebo patients who subsequently received surgical treatment during the next 2-3 years for their BPH symptoms were then prospectively analyzed. Results have now shown that there was 82-95% reduction in the number of these patients who required surgery after they received crossover fexapotide in the trial, as compared to patients who did not receive fexapotide but instead received crossover conventional approved BPH treatments (p<.0001).

“These exciting results from this long-term prospective analysis confirm what I and other researchers have consistently seen in the clinic --  that it is obvious that fexapotide greatly helps patients in terms of symptomatic benefit for their BPH;  and with these results, the clinical benefit also results in much less need for surgical intervention over the long-term. I believe these clinical results, combined with previously reported incidence and progression of prostate cancer in this patient population are truly important.  Furthermore, the extreme safety of this new drug and the lack of sexual side effects are remarkably helpful for patients,” said Dr. Mo Bidair, Medical Director of San Diego Clinical Trials in San Diego, CA and an Investigator who has participated for many years in the Fexapotide Clinical Trials.

 

Nymox has completed and fully financed the execution of seven Phase 3 U.S. BPH (prostate enlargement) clinical protocols, including 2 prospective randomized multicenter single injection double blind clinical trials; 2 U.S. repeat injection clinical trials; and 3 U.S. blinded long-term clinical trial extension studies. In addition, a number of Phase 3 safety and clinical pharmacology studies and analyses have been completed. The Company expects to file for approvals in the next 1-2 quarters.  The Company also expects to report further analyses and results when available in the near future. The Company will publish the findings of the fexapotide clinical trials in peer review medical journals as well as in presentations at medical and urological meetings.

 

“These prospective study results in blinded placebo crossover patients clearly demonstrate that fexapotide reduces the long-term need for surgery by 82-95% compared to approved conventional BPH treatments”, said Dr. Paul Averback MD, CEO of Nymox. “Fexapotide shows significant efficacy against prostate cancer as a therapeutic, and in addition has been shown to reduce the risk of prostate cancer when fexapotide is used to treat BPH. This is in stark contrast to some conventional BPH treatments in routine clinical use today which on the other hand increase prostate cancer risk, and which have many other well known undesirable side effects,” said Dr. Averback.

 

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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.