Dr. Paul Averback reports

NYMOX REPORTS 5-YEAR RESULTS FROM PROSPECTIVE RANDOMIZED CONTROLLED PROSTATE CANCER STUDY OF FEXAPOTIDE TRIFLUTATE IN 146 U.S. MEN

Nymox Pharmaceutical Corp. has released top-line five-year results from its United States study No. NX03-0040. Study No. NX03-0040 was undertaken starting in 2012 at 44 investigational sites across the U.S., comprising a highly representative sample of 146 men with the biopsy-confirmed diagnosis of T1c prostate cancer, which is the most common type of low-grade localized prostate cancer. After five years, the study has now shown that high-dose fexapotide 15-milligram single-dosage treatment resulted in 80 per cent less surgery or radiotherapy associated with Gleason-grade progression (p equal to 0.0003), and that both doses of fexapotide (15 mg and 2.5 mg) were consistently effective (p equal to 0.0003). 4.4 per cent of the patients in the entire fexapotide group showed increases in their Gleason primary pattern grade in the five-year study, compared with controls where the incidence of grade four or higher primary pattern was 23.5 per cent, a reduction of 81.3 per cent (p equal to 0.0061).

Paul Averback, MD, chief executive officer of Nymox, said: "These major new results show the beneficial long-term effect of a single injection of fexapotide triflutate. The results are expected to be even better with regimens of additional or multiple treatment administrations if required."

In the studies fexapotide triflutate was administered by a single painless injection directly into the prostate requiring several minutes or less in an office procedure guided by routine ultrasound. The drug was injected into the area of the prostate where the cancer was previously detected prior to enrolment in NX03-0040; and repeated biopsies every 18 months, serial PSA (prostate-specific antigen) measurements and long-term follow-up were performed on all consenting treated patients and controls subjects. After five years of study, high-dose fexapotide 15 mg single treatment resulted in 80 per cent less surgery or radiotherapy associated with Gleason-grade progression (p equal to 0.0003), and both doses of fexapotide (15 mg and 2.5 mg) were consistently effective (p equal to 0.0003). 4.4 per cent of the patients in the entire fexapotide group showed increase in their Gleason primary pattern grade in the five-year study, compared with controls where the incidence of grade four or higher primary pattern was 23.5 per cent, a reduction of 81.3 per cent (p equal to 0.0061). The new study results also indicated that after five years of study, all recorded instances of surgery or radiotherapy, including elective cases without Gleason upgrades, were decreased by 69.8 per cent (p equal to 0.0002) in fexapotide 15 mg treated patients compared with the randomized control group.

Dr. Averback added: "Eight years of other related U.S long-term phase three BPH studies of fexapotide have shown reduction in new prostate cancer incidence to 1.2 per cent, compared to previous large BPH studies of earlier drugs where the incidence of prostate cancer is in the 10-per-cent-to-20-per-cent range. There are therefore two different long-term fexapotide programs which have now each independently shown that fexapotide has a significant and highly beneficial effect for men with prostate cancer.

"These strong results clearly support management's ongoing efforts to advance both of the company's two major projects towards marketing goals. Nymox expects to report further on its U.S. development plans for registration trials for low-grade prostate cancer. There is a global unmet medical need for more effective prostate treatments without the undesirable side effects of current treatments," said Dr. Averback.

One of the major problems with the main current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation and brachytherapy) is the relatively high incidence of serious sexual problems posttreatment. In nine studies, fexapotide treatment has been shown to have a negligible significant adverse effect posttreatment on sexual function or testosterone levels.

Prostate cancer is the most commonly diagnosed cancer in men, other than skin cancer, and is the second-leading cause of cancer death for men. Approximately 50 per cent of prostate cancers are initially considered low risk.

Fexapotide has shown significant long-term benefit for prostate enlargement (benign prostatic hyperplasia). The recent results of phase three studies of fexapotide for BPH were communicated in podium and symposium presentations to the American Urological Association at four sectional annual meetings in 2017, in Scottsdale (North-central AUA, Nov. 15, 2017), Havana (New York AUA, Nov. 6, 2017), Naples (South-central AUA, Nov. 27, 2017), and Savannah (Northeastern AUA, Oct. 12, 2017). The company has filed for approval for fexapotide in Europe for BPH for prostate enlargement in 2017, and the filing was validated in September, 2017.

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