Dr. Paul Averback reports

NYMOX ANNOUNCES PROSTATE CANCER CLINICAL TRIAL RESULTS FROM COMPLETED 18 MONTH ENDPOINT STUDY

Nymox Pharmaceutical Corp. has released the results from the completion of the company's U.S. 40-month (18-month outcomes) localized prostate cancer phase 2 NX03-0040 clinical trial of fexapotide triflutate (NX-1207). The study successfully met its predetermined end points. Cancer progression clinical outcomes were significantly improved in the fexapotide-treated patient groups.

The clinical trial commenced in February, 2012, at 28 U.S. investigational clinical trial sites and enrolled 147 patients with low-grade localized (T1c) prostate cancer. The study lasted 40 months over all from the first patient randomized to the last patient 18-month end points.

Results from the completed 18-month outcome study after a single injection of fexapotide included the following:

• Absence of tumours (primary end point) controlled for size in baseline area: fexapotide 15 milligrams superior to control (p equals 0.035); crossover fexapotide 15 milligrams superior to control (p equals 0.002); crossover fexapotide overall superior to control (p equals 0.014);
• 75.5-per-cent reduction in biopsy-proven prostate cancer Gleason upgrades (pathological progression) after 18 months in fexapotide 15-milligram-treated patients compared with control (p equals 0.0055); 71.7-per-cent reduction in prostate cancer Gleason upgrades in fexapotide-treated patients over all (p equals 0.0045 versus controls);
• 84.8-per-cent reduction after 18 months in surgery or radiotherapy instituted for prostate cancer Gleason upgrade (biopsy worsening) in fexapotide-treated patients over all compared with control group (p equals 0.014);
• 54.8-per-cent reduction after 18 months in surgery or radiotherapy instituted for all causes with or without prostate cancer Gleason upgrade in fexapotide 15-milligram-treated patients compared with control (p equals 0.026);
• Significant improvement for fexapotide patients compared with controls in four-out-of-four secondary end points; tumour volume reduction in the treated area, combined dosages (p equals 0.04); tumor volume change in prostate over all, fexapotide patients over all (p equals 0.014); median tumour grade outcome in the treated area, all dosages (fexapotide median benign versus control median Gleason three plus three) and superior median tumour grade in prostate over all, fexapotide 15 milligrams versus controls;
• Consistent safety results with no significant drug-related adverse events and no significant related sexual adverse events;
• Overall superior results for the fexapotide 15-milligram dose compared with the 2.5-milligram dose (dose response);
• Other statistically significant improvement outcomes in fexapotide patients compared with controls to be presented comprehensively at medical meetings.

"These results demonstrate that a single-targeted office injection of fexapotide has led to statistically significant improvement in outcomes with much less surgery or radiotherapy required after 18 months. This means a reduction in patient discomfort and a reduction in permanent side effects and life changes when the more invasive treatments are required," said Dr. Paul Averback, chief executive officer of Nymox.

Dr. Averback added, "Based on these outcomes, we believe there are exciting potential patient benefits from one or more painless fexapotide office injections for this common and distressing condition."

The company will report at a later date concerning its plans for moving the compound forward toward the market for this important medical problem.

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