Nymox Reports Positive Results of Safety Monitoring Committee Review of NX02-0018 Phase 3 Trial
August 22 2013 - 10:15AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) reported favorable
results from the most recent Safety Monitoring Committee periodic
review of safety data for the Company's NX02-0018 clinical trial,
one of the two Phase 3 pivotal trials for NX-1207, Nymox's
investigational drug for benign prostatic hyperplasia (BPH). The
August 20, 2013 Safety Monitoring Committee meeting found no
significant safety concerns to date. Both of 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 for the treatment of BPH is in Phase 3 development in
the U.S. and in the EU under the sponsor of the Company's European
licensing partner, Recordati S.p.A. NX-1207 is a first-in-class
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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