Nymox's New Phase 3 Long-Term U.S. Results For Prostate Enlargement Drug Fexapotide Show
August 29 2016 - 10:30AM
1. Dramatic Decrease in Prostate Cancer
and
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) lead drug fexapotide
which has been in development for over a decade and which has been
tested by expert clinical trial investigative teams in over 70
distinguished clinical trial centers throughout the US, 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. This is in
stark contrast to some conventional BPH treatments in routine
clinical use today which on the other hand increase prostate cancer
risk, and which have many other well-known undesirable side effects
such as retrograde ejaculation which is when men lose the ability
to have normal orgasms.
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 now also
shown that the long-term blinded placebo crossover group study
has resulted in 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 this study long-term outcomes were determined in 391
patients who were given double blind placebo injections, which were
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 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 enrolled at these
over 70 top well-known U.S. urological investigational centers, and
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 new data analysis
from the Nymox fexapotide study has now shown the 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.
"These results are astonishingly good. Other
drug treatments and controls tested in similar studies have been
associated with a prostate cancer incidence 10 times higher than
the results reported by Nymox for fexapotide. This is truly good
news. The data strongly indicate that in addition to benefit for
BPH symptoms, fexapotide will also help to prevent cancer in these
patients," said Dr. Ronald Tutrone, one of the Principal
Investigators in the Nymox Fexapotide Prostate Cancer and BPH
studies. Dr. Tutrone is Chief of the Division of Urology,
Greater Baltimore Medical Center; Medical Director of
Chesapeake Urology Research Associates and Chairman of the
William E. Kalhert Endowment for Urological Research.
“These exciting results from this long-term
prospective analysis confirm what I and other researchers have
consistently seen in the clinic -- that it is obvious that
fexapotide greatly helps patients in terms of symptomatic benefit
for their BPH; and with these results, the clinical benefit
also results in much less need for surgical intervention over the
long-term. I believe these clinical results, combined with
previously reported incidence and progression of prostate cancer in
this patient population are truly important. Furthermore, the
extreme safety of this new drug and the lack of sexual side effects
are remarkably helpful for patients,” said Dr. Mo Bidair, Medical
Director of San Diego Clinical Trials in San Diego, CA and an
Investigator who has participated for many years in the Fexapotide
Clinical Trials.
Clinical trial results from Nymox's Phase 2
clinical program for fexapotide previously have been promptly and
frequently reported at large national and international urology
meetings, after the completion of the studies. There were peer
review publications and over 12 well attended presentations to the
AUA and EAU as soon as the Phase 2 data was available. The Company
now greatly looks forward to publication of the results and to the
upcoming presentations of completed Phase 3 data at national and
international medical conferences at the appropriate
time.
Dr. Paul Averback, CEO of Nymox said, "The new
results now add a third dimension to fexapotide utility: clinical
prostate cancer prevention. The drug has now demonstrated
statistically significant prospective long-term outcome data
showing dramatic reduction in the incidence of newly diagnosed
prostate cancer after minimal BPH treatment with fexapotide. Nymox
announced in Q3 last year that it will seek regulatory approvals
for fexapotide for BPH based on the long-term BPH safety and
efficacy data announced Q3 last year. We believe that the exciting
new prostate cancer prevention results will add significantly to
the evidence in fexapotide's favor towards our goal of widespread
major benefit for middle-aged and elderly men."
Dr. Averback added, "These prospective study
results in blinded placebo crossover patients clearly demonstrate
that fexapotide reduces the long-term need for surgery by up to
82-95% compared to approved conventional BPH treatments. We are
extremely grateful to the thousands of people who have been part of
these clinical trials. The Company also thankfully acknowledges our
shareholders for their long-term commitment that supports these
studies."
Nymox has completed and fully financed the
execution of seven Phase 3 U.S. BPH (prostate
enlargement) 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. The Company expects to file for approvals in the next
1-2 quarters. The Company also expects to report further
analyses and results when available in the near future.
Fexapotide is a safe and painless single
injection treatment given in the urologist's office. The drug is in
Phase 3 for BPH and Phase 2 for prostate cancer. It has been tested
in over 1700 drug and placebo treatment administrations in the
U.S. As a treatment for low grade localized BPH, fexapotide
shows long-term efficacy without the safety risk and side effect
concerns or added cancer risk associated with currently approved
BPH treatments. As a treatment for prostate cancer fexapotide was
found to lead to highly statistically significant reduction in
disease progression in a large 147 patient multi-year Phase 2 study
of U.S. men with low grade cancer.
For more information please contact
info@nymox.com or 800-936-9669.
Forward Looking Statements
To 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 Aug 2024 to Sep 2024
Nymox Pharmaceutical (NASDAQ:NYMX)
Historical Stock Chart
From Sep 2023 to Sep 2024