Nymox Announces Positive Safety Monitoring Committee Results for Phase 3 BPH NX02-0020 Repeat Injection U.S. Study
HASBROUCK HEIGHTS, N.J., July 9, 2012 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NYMX) provided an update today on 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 recent Safety Monitoring Committee meeting was favorable and indicated no significant safety concerns for the trial to date. Patient recruitment and trial activities for this U.S. Phase 3 Study are nearing completion at well-known urology investigative sites throughout the U.S.
NX-1207 has been shown to improve the signs and symptoms of BPH, producing improvements which in previous studies have 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 7½ years after a single treatment.
A symposium and panel discussion on NX-1207 was held at the 2012 Annual Meeting of the American Urological Association in Atlanta on May 20 at the Georgia World Congress Center. The symposium, "Clinical studies of NX-1207: Phase 3 Injectable for BPH," was chaired by Ronald Tutrone Jr, MD, FACS of Towson, MD, who has participated in three of the prospective NX-1207 clinical trials as well as follow-up studies. Positive long-term clinical outcome data from studies of NX-1207 for BPH were presented by independent investigators involved in the NX-1207 trials, at American Urological Association meetings in Washington DC, Rancho Mirage CA, New Orleans LA, and Orlando FL in October and November 2011. A peer-reviewed paper in Therapeutic Advances in Chronic Disease featuring NX-1207 was published in November 2011. The paper, "The potential for NX-1207 in benign prostatic hyperplasia: an update for clinicians" was authored by Neal Shore MD FACS, Medical Director of the Carolina Urologic Research Center, Myrtle Beach, SC and Barrett Cowan MD FACS of Urology Associates PC, Englewood, CO.
BPH is one of the most commonly diagnosed conditions in the male population. The condition can seriously impact the health and quality of life of middle aged and older men. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and a high proportion of men as they age suffer from moderate to severe urinary problems and symptoms associated with BPH.
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.
CONTACT: For Further Information Roy Wolvin Nymox Pharmaceutical Corporation 1-800-93NYMOX www.nymox.comSource: Nymox Pharmaceutical Corporation 2012 GlobeNewswire, Inc.