HASBROUCK HEIGHTS, N.J., Sept. 18, 2012 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today positive results of a recent Safety Monitoring Committee review of safety data from the Company's Phase 3 NX02-0020 repeat injection U.S. study for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The Safety Monitoring Committee review was favorable and indicated no significant safety concerns for the trial to date. Patient recruitment for the trial is complete with top-line efficacy results expected near the end of this year. The NX02-0020 trial was initiated in mid-2011, and completed enrollment in June 2012. The study is an open label study of the safety and efficacy of repeat injection of the drug involving 200 men who had previously participated in an NX-1207 clinical trial for BPH.
Previous clinical trials found that a single administration of NX-1207 2.5 mg produced on average improvements in the standardized BPH symptom score (8-10 points at 90 days) that were approximately double that reported for currently approved BPH drugs (3-5 points) without the sexual, blood pressure, or other side effects associated with the approved drugs. Follow-up studies have shown durable clinically significant benefit for up to 7 1/2 years after a single treatment. NX-1207 is administered in an office setting by a urologist. The procedure does not require anesthesia, sedation or catheterization and involves little or no pain or discomfort.
BPH is one of the most commonly diagnosed diseases in older men. The condition can have a significant negative impact on a man's health and quality of life. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and from 26 to 46% of men between the ages of 40 to 79 years suffer from moderate to severe urinary problems and symptoms associated with BPH.