Nymox Reports Additional Positive Results From Completed Fexapotide BPH Phase 3 Studies Showing Significant Early Response an...
November 29 2016 - 9:45AM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to
announce that new Phase 3 prospective randomized clinical trial
results have confirmed that patients who received fexapotide as
their initial treatment for BPH (prostate enlargement) had superior
efficacy results as early as 10 days compared to control patients
who received placebo or who had prior history of other BPH medical
treatments. These new Phase 3 results indicate that fexapotide in
these trials was highly efficacious for first-line treatment of
BPH.
These findings are from analysis of the
Company's extensive U.S. Phase 3 trials NX02-0017, NX02-0018,
NX02-0020 and NX02-0022 including long-term follow-ups that were
undertaken from 2009 to 2016. These important results come on top
of many other positive results including successfully reaching
long-term primary efficacy endpoints, that have previously been
reported. The present prospective randomized trial results are new
findings. 390 treatment naive patients with no past treatments for
BPH had improvements greater than previously treated BPH patients
as early as 10 days post-treatment (p<.02) and at one month
(p<.04), 3 months (p<.001), six months (p<.001), one year
(p<.01) and at long-term (3.5 years) follow-up (p<.003). The
levels of mean change from baseline pre-treatment ranged from 6.49
to 8.88 points improvement in the AUA BPH Symptom Score. These
previously untreated patients who received a single injection of
fexapotide 2.5 mg also had statistically significant superior
improvements compared to patients who received placebo treatments,
as early as 10 days post-treatment (p<.001) and at several time
points also including the long-term (3.5 years) follow-up extension
(p<.001).
Dr. Paul Averback, CEO of Nymox said, "It is
important to have now demonstrated for Nymox's fexapotide, both 1.
that it leads to an early onset of clinically noticeable
improvement; and 2. that it works well long-term as a first-line
therapeutic for men who have not tried other treatments before.
There is a major unmet need for a convenient, safe and efficacious
treatment for countless men worldwide with BPH who are unhappy with
their symptoms and who may be unhappy with their available
choices."
Traditional BPH treatments have very undesirable
side effects, particularly causing frequent problems with
ejaculation and overall sexual function, as well as many other
limiting side effects. Pills for BPH usually need to be taken
permanently to remain effective and surgical treatments for BPH
often produce permanent distortions of ejaculation as well as other
risks. Middle aged and elderly male patients often need a safer and
more effective way to manage these extremely common life
problems.
Nymox's lead drug fexapotide has been in
development for over a decade and has been tested by expert
clinical trial investigative teams in over 70 distinguished
clinical trial centers throughout the US, and has been found after
7 years of prospective placebo controlled double blind studies of
treatment of 995 U.S. men with prostate enlargement to not only
show clinically meaningful and durable relief of BPH symptoms, but
also to show a major reduction in the incidence of prostate cancer,
compared to placebo and compared to the known and expected normal
incidence of the disease. The same clinical program conducted
at the same highly regarded treatment centers under rigorous trial
scrutiny and performed strictly at arms-length by top teams of
clinical investigators across the country, has also shown in a
long-term blinded placebo crossover group study an 82-95% reduction
in the number of these patients who required surgery after they
received crossover fexapotide in the trial, as compared to patients
who did not receive fexapotide but instead received crossover
conventional approved BPH treatments (p<.0001). The aim of the
crossover study was to determine the clinical benefit fexapotide
can provide to men who initially were double blind randomized to
and received placebo, remained blinded as to their placebo
treatment, and who subsequently required additional medical and/or
surgical treatment. In that study long-term outcomes were
determined in 391 patients who were given double blind placebo
injections, followed by crossover to other treatments at the
patients' discretion. The numbers of blinded placebo patients who
subsequently received surgical treatment during the next 2-3 years
for their BPH symptoms were then prospectively analyzed.
For the earlier fexapotide Phase 3 long-term
cancer incidence analysis, the men in the study received fexapotide
or placebo for the treatment of their prostate enlargement (BPH)
symptoms. All men were thoroughly evaluated at expert urological
testing investigational centers to exclude any prostate cancer
prior to qualifying for enrollment in the studies. The participants
were followed for up to 7 years (median of 5 years) after
treatment. The study analyzed all cases of prostate cancer that
were subsequently diagnosed. The expected rate of new prostate
cancer in the U.S. general male population in this age group is in
the 5-20% range after 7 years. In the BPH population in published
large trials of drugs for the prevention of prostate cancer, the
incidence of new prostate cancer cases after 4-7 years has been
reported in major studies to be 20-25%. The data analysis from the
Nymox fexapotide study showed a statistically significant and very
low incidence of 1.3% for prostate cancer in this comparable
fexapotide treated BPH population. By comparison, for example in a
population of patients with erectile dysfunction treated with PDE5
inhibitor drugs after 4 years the rate of subsequent prostate
cancer was 19.5% (and 22.7% in controls) as recently reported in a
large U.S. study published in the Journal of Urology (Volume 196;
3, 2016). The quoted study was in a population of middle aged and
elderly men without prostate cancer, similar to the Nymox study
population.
Nymox recently announced (October 11, 2016)
positive long-term results in 344 patients who were given a single
repeat fexapotide treatment after initial blinded treatment with
fexapotide or placebo. Patients were followed for 2 to 6.5 years
(mean 4.2 years) after initial treatment and showed long-term
statistically significant symptomatic improvement (mean improvement
of 6.5 points in the AUA BPH Symptom Score) compared to Phase 3
patients who received placebo alone (p<.001). Repeat injection
was found to be safe with no significant drug related toxicities or
side effects found in the study.
Nymox has completed the execution of seven Phase
3 U.S. BPH clinical protocols, including 2 prospective randomized
multicenter single injection double blind clinical trials; 2 U.S.
repeat injection clinical trials; and 3 U.S. blinded long-term
clinical trial extension studies. In addition, a number of Phase 3
safety and clinical pharmacology studies and analyses have been
completed.
For more information please
contact info@nymox.com or 800-936-9669.
Forward Looking StatementsTo the extent that
statements contained in this press release are not descriptions of
historical facts regarding Nymox, they are forward-looking
statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, including
statements regarding the need for new options to treat BPH and
prostate cancer, the potential of fexapotide to treat BPH and
prostate cancer and the estimated timing of further developments
for fexapotide. Such forward-looking statements involve substantial
risks and uncertainties that could cause our clinical development
program, future results, performance or achievements to differ
significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, the uncertainties inherent in the clinical drug
development process, including the regulatory approval process, the
timing of Nymox's regulatory filings, Nymox's substantial
dependence on fexapotide, Nymox's commercialization plans and
efforts and other matters that could affect the availability or
commercial potential of fexapotide. Nymox undertakes no obligation
to update or revise any forward-looking statements. For a further
description of the risks and uncertainties that could cause actual
results to differ from those expressed in these forward-looking
statements, as well as risks relating to the business of Nymox in
general, see Nymox's current and future reports filed with the U.S.
Securities and Exchange Commission, including its Annual Report on
Form 20-F for the year ended December 31, 2015, and its Quarterly
Reports.
Contact:
Paul Averback
Nymox Pharmaceutical Corporation
800-93NYMOX
www.nymox.com
Nymox Pharmaceutical (NASDAQ:NYMX)
Historical Stock Chart
From Apr 2024 to May 2024
Nymox Pharmaceutical (NASDAQ:NYMX)
Historical Stock Chart
From May 2023 to May 2024