Nymox Reports Top-Line Results for Localized Prostate Cancer Study
April 30 2014 - 9:30AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to report
top-line results from the company's 146 patient NX03-0040 Phase 2
U.S. prostate cancer study. The results from the study indicate an
overall benefit in terms of reduced progression in patients with
low grade localized (T1c) prostate cancer treated with a single
injection of NX-1207 into the area of the prostate where cancer was
found. Consistent with earlier clinical trial experience with
NX-1207, there were no significant safety issues or side effects
associated with the drug in the new study.
In the study, patients given a single targeted injection of
NX-1207 had less evidence of cancer progression in the treated area
than untreated patients (0.9% vs 6.3%, relative risk 0.15) as
determined by Gleason grade. Gleason grade is the standard accepted
pathological measure of the degree of malignancy of prostate cancer
(higher grade is more malignant). Overall, the number of biopsy
cores showing higher grade of malignancy was significantly lower
for NX-1207 treated patients compared to controls in the treated
area (p=.032), in the treated side of the prostate (p=.004), and in
the prostate overall (p=.004). The total volume of more malignant
cancer detected in the treated area and throughout the prostate was
statistically significantly reduced in the NX-1207 treated patients
compared to controls.
PSA decreased from baseline in drug treated patients with high
dose (15 mg) declining more than low dose (2.5 mg), while controls
were unchanged. In patients with proven prostate cancer PSA is a
conventional measure of prostate cancer worsening (increased PSA)
or improvement after treatment (decrease). In the small subgroup of
patients with increased Gleason grade on repeat biopsy, the mean
PSA in NX-1207 treated patients also decreased as compared to
controls which was unchanged.
There was also a dose-response trend with high dose (15 mg)
treated patients showing better responses than low dose (2.5 mg)
treated patients on a variety of parameters.
The primary efficacy endpoint, the percentage of subjects with
undetectable prostate cancer (negative biopsy) 45 days
post-treatment in the region of the prostate where the baseline
cancer was detected, proved to be unable to be assessed because of
the high percentage of false negative repeat biopsies in the active
surveillance control arm. In the study, an unexpectedly high
proportion of enrolled patients had baseline biopsies with only
evidence of an extremely small tumor (5% or less of their single
positive core biopsy). This included 68.8% of the active
surveillance control patients. For 85% of these control patients,
the second biopsy was unable to detect the known cancer tumor found
by the original baseline biopsy, making meaningful analysis of the
percentage of subjects with a negative second biopsy
impossible.
The trial enrolled 146 patients with baseline biopsy positive
low grade localized prostate cancer who were randomized in a 1:1:1
ratio to low or high dose NX-1207 (n=47; n=46 respectively), or to
standard active surveillance (n=48). Active surveillance
patients after re-biopsy were also given crossover NX-1207 if they
so elected and still met original inclusion/exclusion criteria
(n=16). Pre- and post-treatment biopsies were blindly
assessed for endpoints (including presence, Gleason grade, and % of
tumor(s) in 15 biopsy cores) and pre- and post-treatment serial
serum PSA tests were blindly done on all patients. Over 3800
individual biopsy cores were analyzed in the study. Follow-up
of trial participants is continuing.
Nymox's CEO Paul Averback MD said "We emphasize that these
results are based on a single focal injection of drug, which is a
minimal treatment. A multiple injection regimen is expected to
further increase efficacy. A major potential advantage of NX-1207
treatment is that the drug can be repeatedly administered in a
simple painless procedure with little discomfort to the patient and
with minimal side effects or safety issues. Therefore we are
optimistic about the possibilities of NX-1207 for low grade
prostate cancer. Low grade localized prostate cancer is
usually not immediately life threatening but it is nevertheless
unfortunately a serious life changing problem for countless men.
Currently available treatments - apart from non-treatment and
surveillance - can cause debilitating and often permanent side
effects which are undesirable. Painless injection(s) of NX-1207
without the significant risks and permanent sexual and other side
effects of surgery or radiation has potential benefits for this
common clinical problem. Reduced tumor progression in this study
suggests that if there is further validation, NX-1207 can
potentially become a safe treatment option for men with low grade
localized prostate cancer."
The Company intends to advance further development of NX-1207
for low grade prostate cancer. Nymox is actively pursuing potential
partnerships with pharmaceutical companies for US and global
marketing agreements for this indication.
NX-1207 is in phase 3 development in the US and Europe for
benign prostatic hyperplasia (BPH) also referred to as prostate
enlargement, a common affliction of middle-aged and elderly men,
affecting up to half of men over the age of 50. The Company's
European partner for BPH is Recordati S.p.A.
Further clinical and scientific details of the NX03-0040
prostate cancer study will be presented at a later date at medical
meetings and in peer-reviewed publications.
A teleconference to discuss the news with management will be
held at 2:00 pm on May 1, 2014. The toll-free dial-in number to
participate on this call is (877) 261-8992 (U.S. and Canada),
confirmation code: 37214654. The toll-free dial-in number for
International is (847) 619-6548, confirmation code: 37214654.
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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