Nymox Announces Positive Efficacy Results in Phase 3 Repeat Injection Trial of NX-1207 for BPH
July 22 2014 - 8:30AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to
announce new positive efficacy data for U.S. Study NX02-0022, the
Company's repeat injection study of NX-1207 for BPH. Analysis of
symptomatic improvement from repeat injection over a 1 to 2 year
period showed a mean improvement of 8.2 points (p <.001) in the
AUA BPH Symptom Index Score. Evaluation of safety data from this
study confirmed that NX-1207 reinjection treatment was
well-tolerated by patients, did not impair sexual function, and has
not shown any drug-related significant side
effects. Participants in the clinical trial consisted of 160
consecutively treated men who had previously completed
participation in an NX-1207 trial for BPH (the Phase 2 U.S.
NX02-0014 or NX02-0016 trials or the U.S. Phase 3 NX02-0017 or
NX02-0018 trials) and who volunteered for a subsequent open label
injection of NX-1207.
The NX02-0022 study is the second prospective clinical safety
and efficacy evaluation of re-injection of the Company's NX-1207
drug for prostate enlargement (benign prostatic hyperplasia or
BPH). The mean duration in this study from the initial
enrollment prior to the first injection, to the assessment in the
NX02-0022 trial was 23.5 months. Symptomatic improvement was
assessed at 30 days after the open label reinjection of NX-1207 2.5
mg in the NX02-0022 study. The mean symptomatic improvement of 8.2
points is in a similar range to the mean improvement of 7.6 points
(p<.001) earlier reported for the first NX-1207 reinjection
trial NX02-0020. It is also in the range of the completed NX02-0016
NX-1207 study where the mean improvement after 6 months was 7.5
points. These values are considerably higher than typically
reported for the currently approved BPH medications (3 to 5 points)
the latter which need to be taken on a daily basis
indefinitely.
Further analysis of this data will be conducted following longer
follow-up and also following the unblinding of the NX02-0017 and
NX02-0018 trials. Results from the 3 month and 6 month time points
post second injection for Study NX02-0022 will be reported
separately when available.
NX-1207 is a novel drug developed by Nymox for the treatment of
BPH and localized prostate cancer. The drug is administered
transrectally in a simple routine office injection that takes only
a few minutes, does not require sedation, anesthesia or
catheterization, and involves little or no pain or discomfort.
NX-1207 previously 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 the standardized symptom score much higher than 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 many
men who received a single dose reporting maintained improvement in
BPH symptoms without other treatments for up to 5 years or
more.
BPH is one of the most commonly diagnosed diseases in men. The
condition can have a very negative impact on a man's health and
quality of life and can lead to urinary retention, incontinence and
other medical consequences. BPH increases with age and it is
estimated that at least half of men in their 60's or older have
histopathological BPH and about a third of men at that age suffer
from urinary symptoms and problems 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: Brian Doyle
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com
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