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Nymox Pharmaceutical Corporation
For Immediate Release:
Nymox Announces Positive Safety Monitoring Committee Results
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
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
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: email@example.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