Nymox Reports Positive Safety Monitoring Committee Results for Pivotal NX02-0017 Phase 3 Trial
Nymox Pharmaceutical Corporation (Nasdaq: NYMX) reported favorable results from the most recent Safety Monitoring Committee review of ongoing safety data for the Company's NX02-0017 clinical trial, one of the two Phase 3 pivotal trials for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The July 9, 2013 Safety Monitoring Committee meeting found no significant safety concerns to date. The Company's pivotal Phase 3 trials have completed enrollment and treatment (a single intraprostatic injection of either drug or placebo) and patient evaluation is continuing at over 70 well-known urology investigative sites across the U.S.
NX-1207 is in late stage Phase 3 development in the U.S. for BPH. Phase 3 trial activities of NX-1207 for BPH are ongoing under the sponsor of the Company's European licensing partner, Recordati S.p.A. NX-1207 is a novel patented therapeutic that is administered directly into the prostate by a urologist in an office setting. The procedure does not require anaesthesia, sedation, or catheterization, takes only a few minutes and involves minimal discomfort to the patient. NX-1207 has thus far shown none of the adverse sexual side effects associated with approved medical and surgical treatments for BPH.
Previous clinical trials found that a single administration of NX-1207 2.5 mg 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) without the sexual, blood pressure, or other side effects associated with the approved drugs. Follow-up studies have shown durable clinically significant benefit for up to 7 ½ years after a single treatment.
BPH is one of the most commonly diagnosed diseases in older men. The condition can have a significant negative impact on a man's health and quality of life 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. 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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