Nymox Announces Current Safety Monitoring Committee Results and Update For Phase 3 NX-1207 Trials
HASBROUCK HEIGHTS, NJ (February 15, 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
Safety Monitoring Committee meeting of February 14, 2012 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 at over 80 well-known urology investigative
sites throughout the U.S. Overall accrual numbers for Trials
NX02-0017, NX02-0018 and NX02-0020 have reached approximately 980
patients, and good progress is being made toward full enrollment
for the pivotal studies.
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.
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 in
October and November 2011. A recent peer-reviewed paper in
Therapeutic Advances in Chronic Disease featuring NX-1207 was
published in November 2011 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.
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.
Posted: February 2012
