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Nymox Pharmaceutical Corporation : Nymox Announces Positive Safety Monitoring Committee Results for Phase 3 NX-1207 Trials for BPH

04/27/2012 | 03:37pm EDT
NEWS RELEASE For Further Information Contact:

Roy Wolvin

Nymox Pharmaceutical Corporation



For Immediate Release:

Nymox Announces Positive Safety Monitoring Committee Results for Phase 3 NX-1207 Trials for BPH

HASBROUCK HEIGHTS, NJ (April 26, 2012) Nymox Pharmaceutical Corporation (NASDAQ: NYMX) provided an update today on the Company's Phase 3 U.S. trials for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The most recent Safety Monitoring Committee meeting was favorable and indicated no significant safety concerns for the three ongoing U.S. Phase 3 trials to date. Patient recruitment and trial activities for U.S. Phase 3 studies NX02-
0017, NX02-0018 and NX02-0020 are ongoing and nearing completion at over 80 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 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 will be 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," will be 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. Dr. Tutrone will present an overview of NX-
1207 and the NX-1207 clinical trials to date, including the two Phase 3 clinical trials currently in progress. Barton H. Wachs, MD, FACS, of Long Beach, CA, will present data from the new studies of the long-term efficacy of NX-1207 treatment. Mohamed Bidair, MD, FACS(C) of San Diego, CA, and Nicholas Franco, MD, FACS of Naples, FL will participate in the panel discussion in the symposium, along with Dr. Tutrone and Dr. Wachs. All four symposium panelists are distinguished Board-certified urologists with extensive experience as clinical investigators in FDA-regulated clinical trials, including the NX-1207 clinical trials.
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 recent 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. 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.
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.
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.

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