Nymox reports positive new results from pooled analysis of NX-1207 clinical trials for BPH

Jul 8 2010

Nymox Pharmaceutical Corporation (Nasdaq:NYMX) reported today positive new results from pooled analysis of completed clinical trials of NX-1207, the Company's investigational drug for BPH. The trial data shows that patients receiving NX-1207 recorded significant quantitative improvement in the important symptom of urgent need to urinate. Compared to baseline, symptoms of urgency to urinate were reduced by 52% at 90 days after a single treatment with NX-1207, and this improvement was statistically significant compared to double-blinded placebo control patients (p<.003).

The urgent need to urinate is considered by experts to be one of the symptoms of BPH that may cause the greatest degree of bother in men with the condition (see for example the recent article published in Urol. Int. 2010:84(4):424-9, which concluded that urgency was much more deeply implicated in discomfort than frequency of nocturia, Robert G, Descazeaud A, Azzouzi R, Saussine C, Haillot O, Dumonceau O, Ballereau C, Fourmarier M, Devonec M, Lukacs B, Delongchamps NB, Desgrandchamps F, de la Taille A. Impact of lower urinary tract symptoms on discomfort in men aged between 50 and 80 years.). Without treatment, this irritative symptom can progress to other serious problems. NX-1207 has been shown to improve the signs and symptoms of BPH, producing an improvement which has been statistically significantly better than double-blinded placebo and study controls and is higher than the improvement reported for approved drugs for BPH. 

A statistically significant difference in standardized BPH symptom score improvement at mean 13.5 months after a single treatment was found between NX-1207 2.5 mg (the therapeutic dose of NX-1207) and placebo. The median improvement in BPH Symptom Score in subjects given a single injection of NX-1207 at 12 months was 9.0 points (p<.003).

Completed clinical trials to date have shown that men treated with NX-1207 reported statistically significant improvement in BPH symptoms 3 months after a single NX-1207 treatment with no reported serious drug-related side effects, including no (0%) significant sexual side effects. In two multi-center Phase 2 U.S. prospective randomized blinded clinical trials, the aggregated mean improvement in the BPH symptom score for 2.5 mg NX-1207 was 10.3 points or a 44% improvement in BPH symptom score. By comparison, currently approved drugs for BPH provide on average 3 to 5 points improvement, must be taken daily to achieve or maintain benefit, and often have unwanted side effects such as impotence, loss of libido, retrograde ejaculation, dizziness, and weakness.

NX-1207 is a novel patented drug developed by Nymox which is currently in Phase 3 trials.

NX-1207 is injected by a urologist in an office setting and involves little or no pain or discomfort. For more information about the NX-1207 Phase 3 clinical trials please go to www.clinicaltrials.gov or contact Nymox at [email protected].

Urologists in the U.S. have expressed very positive comments about the potential of NX-1207 to improve the care of millions of men with BPH. BPH treatment represents a growing market with more than 100 million men worldwide being estimated to suffer from BPH symptoms. The disorder is a common affliction of older men, affecting approximately half of men over age 50 and close to 90% of men by age 80, and is associated with growth in prostate size as men age.