Nymox
Pharmaceutical Corporation 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.
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