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HASBROUCK HEIGHTS, N.J., Feb. 21, 2013 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) provided an update today on the Company's Phase 3 pivotal trials for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The Safety Monitoring Committee meeting of February 18, 2013 to review safety data from the Phase 3 trials was favorable and indicated no significant safety concerns to date. Trial activities for pivotal U.S. studies NX02-0017 and NX02-0018 are in late stages at well-known urology investigative sites throughout the U.S.
Nymox recently announced on January 22 new positive efficacy and safety data from Phase 3 Study NX02-0020. In the NX02-0020 study, 192 patients with BPH given 1 or 2 NX-1207 treatments showed sustained statistically significant improvement in their BPH symptoms for an average period of over 2 years. The NX02-0020 study indicated no safety concerns for the drug.
Nymox reported on February 19 that clinical immunogenicity testing of men in the Phase 3 trials showed no abnormalities. These immunogenicity results also bolster the safety profile of the new drug.
NX-1207 has been found in previous studies to improve the signs and symptoms of BPH, producing improvements which reached statistical significance compared to double-blinded placebo and study controls. A single administration of NX-1207 2.5 mg has 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). The drug is administered by a urologist in an office setting and involves little or no pain or discomfort. NX-1207 has not been found to have the sexual, blood pressure, or other side effects of the approved drugs. Follow-up studies have shown clinical efficacy effects in many men lasting up to 7 ½ years after a single treatment.
BPH is one of the most commonly diagnosed diseases in the male U.S. population. The condition can seriously impact the health and quality of life of older men and can lead to acute urinary retention, incontinence, and other serious consequences. 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.