Nymox Reports Positive Safety Monitoring Committee Results for Pivotal NX02-0017 Phase 3 Trial
July 11 2013 - 12:45PM
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: 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. Such
factors are detailed from time to time in Nymox's filings with the
United States Securities and Exchange Commission and other
regulatory authorities.
CONTACT: For Further Information Contact:
Brian Doyle
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com
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