Nymox
Pharmaceutical Corporation NYMX is pleased to report new data
supporting the positive sexual functional preservation profile of NX-1207, the
Company's lead compound in Phase 3 development for the treatment of prostate
enlargement (BPH or benign prostatic hyperplasia) and Phase 2 development for
localized prostate cancer. A detailed study of prostate tissues from men who
had received intraprostatic injections of NX-1207 2.5 mg or 15 mg found that
nervous tissues in the prostate after treatment were left intact and showed no
damage. These new results showing that NX-1207 is nerve-sparing add to the
considerable body of evidence that treatment with NX-1207 does not lead to the
debilitating sexual side effects often associated with existing prostate
treatments.
Men who receive surgical or drug treatments for BPH or prostate cancer, not
uncommonly suffer sexual side effects of a permanent nature. These long term
effects can include impotence, retrograde ejaculation, loss of libido, and
other disorders. For this reason, men are often reluctant to seek necessary
treatment or to continue with drug therapy.
The nerve-sparing findings are consistent with results from earlier studies
which have shown evidence of sexual functional preservation in men after
NX-1207 treatment, including 1) patient reports of no significant new clinical
sexual problems, 2) no change in blood testosterone levels, and 3) sexual
function questionnaire data showing no sexual side effects from NX-1207
treatment.
NX-1207 is a novel patented drug developed by Nymox that is administered by a
urologist in an office setting directly into the zone of the prostate to be
treated. The procedure takes only a few minutes, does not require sedation,
anesthesia or catheterization, and involves little or no pain or discomfort.
NX-1207 successfully completed a series of blinded controlled multi-center
U.S. clinical trials for BPH where a single 2.5 mg dose of NX-1207 was found
to produce at 90 days an average improvement in standardized symptom score
about double that reported for currently approved BPH drugs without causing
the sexual or cardiovascular side effects associated with those drugs.
Follow-up studies showed evidence of long lasting benefit with a significant
proportion of men who received a single dose reporting maintained improvement
in BPH symptoms without other treatments for up to 5 years or more.
Nymox recently announced the completion of its second pivotal Phase 3 trial of
NX-1207 for BPH, NX02-0018, and top-line results for its Phase 2 trial of
NX-1207 for localized low risk prostate cancer, NX03-0040.
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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