Nymox Announces New Positive Long-Term 39-45 Month Follow-Up Results From NX02-0016 U.S. Study of NX-1207 for BPH
New Study Results Indicate Durable Clinical Response to New
Therapy for Enlarged Prostate Currently in Phase 3
HASBROUCK HEIGHTS, NJ (April 13, 2011) Nymox Pharmaceutical
Corporation (NASDAQ: NYMX) is pleased to report positive new
results from the 39-45 month follow-up study of patients treated
with NX-1207 in Study NX02-0016. The initial study, completed in
the U.S. in 2007, reached statistical significance in
Intent-to-Treat Primary Efficacy outcomes at 90 days and 6 months
post-treatment with NX-1207 2.5 mg. The new study assessed American
Urological Association BPH Symptom Index scores in blinded subjects
without additional NX-1207 treatment after 39-45 months. There were
no significant drug safety problems reported by any subjects in the
study initially as well as in the new long-term follow-up.
Patients in the new study were followed and have remained blinded
as to treatment subsequent to their participation in Nymox’s
U.S. Study NX02-0016. The initial study was undertaken in 2007 at
32 U.S. sites and enrolled 85 subjects. The new study includes
results from all currently available patients. The new study found
that 54% of available patients who received NX-1207 2.5 mg had
required no further medical or surgical treatments for their BPH at
any time in the long-term follow-up period. Patients who received
NX-1207 2.5 mg without any other subsequent treatment for their BPH
had a mean improvement at 39-45 months of 11.5 points in their
symptom scores. In the control group only one subject had not
required
any additional BPH treatments. The NX-1207 2.5 mg cohort’s
level of improvement reached statistical significance. 58% of the
NX-1207 2.5 mg subjects and controls were available for the
follow-up study. Additional data from this new long-term study will
be released at a later date.
In the initial study’s Intent-to-Treat cohort after 90 days,
the tested therapeutic dose of NX-1207 had a mean BPH Symptom Score
improvement of 9.71 points, which was markedly better than the
improvement shown by control groups (p<.001). In multicenter
U.S. clinical trials to date NX-1207 has been found to produce
improvements in BPH symptom score that are approximately double
that reported for currently approved BPH drugs without the side
effects associated with those drugs, which can include sexual
problems (such as impotence, loss of libido, and retrograde
ejaculation), blood pressure changes and other adverse reactions.
Results of follow-up studies of available subjects from NX-1207
clinical trials have provided evidence of durable benefits from
NX-1207 treatment for up to 7½ years from the date of
treatment.
NX-1207 is a novel patented drug developed by Nymox which is
currently in Phase 3 trials. NX-1207 is injected by a urologist in
an office setting and involves little or no pain or discomfort. For
more information about the NX-1207 Phase 3 clinical trials please
go to www.clinicaltrials.gov or contact Nymox at
info@nymox.com.
BPH treatment represents a growing market with more than 100
million men worldwide being estimated to suffer from BPH symptoms.
The disorder is a common affliction of older men, affecting
approximately half of men over age 50 and close to 90% of men by
age 80, and is associated with growth in prostate size as men
age.
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.
For Further Information Contact:
Roy Wolvin
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com
Posted: April 2011
