Nymox Announces Positive Prostate Cancer 8-Month Clinical Trial Results, Statistical Significance Reduced Compared to Controls

NymoxPharmaceutical Corporation (Nasdaq: NYMX) announced today new positive outcomeresults from the Company's ongoing prospective NX03-0040 trial of NX-1207 forthe treatment of low grade localized prostate cancer. Clinical outcomes weredetermined at 8 months from the initial treatments. A controlled comparisonwas conducted of patients who required and received radiation and surgerytreatments for their cancer based on blinded post-treatment upgradedevaluations of their pre-treatment initially positive lower grade cancers. Thestudy found after 8 months for NX-1207 single-injection treated patients thatthere was a statistically significant reduction compared to controls of morethan 75% (p=.002) in the proportion of patients who had upgraded blindedbiopsy and laboratory results and went on to require and receive radiationtherapy and/or surgery. The new results also indicated that the NX-1207treated patients had 67% less progression to surgery and/or radiotherapycompared to controls (p=.008) for all reasons (including elective surgeryand/or radiotherapy with no biopsy or laboratory upgrades).146 patients were enrolled in the NX03-0040 Phase 2 U.S. trial and eitherrandomized to one of two doses of NX-1207 (2.5 mg or 15 mg) or to activesurveillance. The drug was injected into the area of the prostate where thecancer was detected and repeat biopsies were then performed on all patients,drug treated and controls. The patients in the active surveillance group inthe study who were eligible could elect crossover drug treatment after theirfirst follow-up rebiopsy. Follow-up studies are being conducted of allconsenting patients in the study to continue to monitor outcome and safetydata.These new findings extend the previously reported study results which showedthat patients with NX-1207 treatment after 2 months had less clinicalprogression and significantly less Gleason grade progression, lower averagePSA levels, lower numbers of biopsy cores showing greater malignancy, andlower total volume of more malignant cancer compared to controls.To date, NX-1207 has had an excellent safety profile as both a treatment forbenign prostatic hyperplasia (BPH) and localized low-risk prostate cancer. Inthe current trial, a new high dose of drug (15 mg) was safely used withoutdrug-related adverse effects. NX-1207 has shown safety in repeat injectionstudies (NX02-0020 and NX02-0022). The drug does not lead to immune responsessuch as antibody formation which can cause significant drug toxicity and/orlimit usage to single treatments due to drug neutralizing effects.Prostate cancer is the most commonly diagnosed cancer in men, other than skincancer, and is the second leading cause of cancer death for men. An estimated233,000 cases will be newly diagnosed in the U.S. in 2014 with approximately50% of them being initially considered low risk.NX-1207 is in Phase 3 development in the US and Europe for benign prostatichyperplasia (BPH) also referred to as prostate enlargement, a common conditionof middle-aged and elderly men affecting up to half of men over the age of 50.The Company's European partner for BPH is Recordati S.p.A.