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Nymox Reports Safety Benefits of Fexapotide Treatments for Prostate Cancer and Benign Prostatic Hyperplasia
GlobeNewswire•October 3, 2018

HASBROUCK HEIGHTS, N.J., Oct. 03, 2018 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NYMX) reported today that after long-term safety assessments of repeated Fexapotide Triflutate (FT) intraprostatic injections, there have been no identifiable risks or serious side effects or adverse events identified associated or linked with the drug.

FT is Nymox's lead drug for which the Company is in the process of seeking U.S. and European marketing approvals for BPH (prostate enlargement), and FT is also in late stage development for prostate cancer. Pivotal trial results for FT BPH studies involving 977 treated patients were published in 2018 in the prestigious World Journal of Urology (May 2018, Volume 36, pages 801–809), and the safety and efficacy results have been presented to the American Urology Association and previously to the European Association of Urology.

Dr. Paul Averback, CEO of Nymox said, "For prostate cancer in particular, repeated injection treatments will be needed and a focal molecular treatment will have negligible value if there cannot be reliable safety expected from repeated injection. Prostate cancer is a multi-focal disease and it is to be expected that multiple focal molecular treatments will be utilized for optimal outcomes. Follow-up and re-treatment will be needed. Nymox undertook 2 large FT re-injection safety studies in 2010-2014 involving 351 subjects with BPH, who were subsequently followed for up to 7 years. These mandatory and adequately sized safety studies are absolutely required in order to demonstrate safety of re-injection, and this is a standard requirement."

Dr Averback added, "In addition, Nymox undertook extensive immunological testing involving over 1000 subject samples, demonstrating that FT does not lead to detectable antibody formation, which underlines FT safety and supports the lack of risk for allergic reactions. All laboratory testing and sexual function tests including semen analyses showed no changes in FT treated men compared to controls."

Nymox's lead drug Fexapotide (FT) has been in development for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 977 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. The same clinical program has also shown in a long-term blinded placebo group study an 82-95% reduction in the number of these patients who required surgery after they received FT in the trial, as compared to patients who did not receive FT but instead later received conventional approved BPH treatments (p<.0001).