Nymox Provides Safety Monitoring Committee Results and Update For Pivotal Phase 3 NX-1207 Trials
HASBROUCK HEIGHTS, NJ (November 22, 2011) 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 November 15, 2011 was favorable and indicated no significant safety concerns for the two pivotal U.S. trials to date. Patient recruitment and trial activities for pivotal U.S.
studies NX02-0017 and NX02-0018 are ongoing at over 80 well-known urology investigative sites throughout the U.S.
Accrual numbers for Trial NX02-0017 have reached approximately 80%, and steady progress has been made toward full enrollment for the pivotal studies.
Recent podium, panel, and moderated poster presentations concerning positive long-term clinical outcomes from trials of NX-1207 for BPH were given by independent investigators involved in the NX-1207 trials, to the American Urological Association at meetings in Washington DC, Rancho Mirage CA, New Orleans LA, and Orlando FL. A new peer-reviewed paper in Therapeutic Advances in Chronic Disease featuring NX-1207 was recently published entitled, “The potential for NX-1207 in benign prostatic hyperplasia: an update for clinicians” written 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. Dr. Shore and Dr. Cowan are well known experts in urology and have participated as clinical investigators in clinical trials of NX-1207 as well as in multiple follow-up studies of the drug.
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 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.
More information about Nymox is available at www.nymox.com, email: firstname.lastname@example.org, 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.
Posted: November 2011