HASBROUCK HEIGHTS, N.J., Feb. 18, 2009 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today that the Company has recently concluded a positive and productive EOP2 meeting with the FDA concerning the Phase 3 program for NX-1207, the Company's investigational drug for benign prostatic hyperplasia (BPH). The pivotal Phase 3 trials for NX-1207 that are being undertaken will incorporate the specific protocol design recommendations provided to the Company by the FDA.
The Phase 3 studies for NX-1207 are being conducted at well known investigational sites across the U.S. Information concerning individual sites and patient recruitment activities will be made public in the upcoming weeks.
NX-1207 has been shown 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 produced on average improvements in the standardized BPH symptom score that were approximately double that reported for currently approved BPH drugs. NX-1207 involves a new targeted approach to the treatment of BPH. The drug is administered by a urologist in an office setting directly into the zone of the prostate where the enlargement occurs. The injection takes only a few minutes 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.
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.
More information about Nymox is available at www.nymox.com, email: info@nymox.com, or 800-936-9669.
This press release contains certain "forward-looking statements" as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management's current expectations. Development of drug products involves substantial risks and actual results may differ materially from expectations. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.