Nymox Reports Successful New Phase 3 Long-Term Fexapotide Repeat Injection BPH Trial Results: Lasting Symptomatic Improvement...
October 11 2016 - 10:00AM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to
announce successful new study results from the long-term repeated
injection group from the U.S. Phase 3
trials for fexapotide, the Company's lead compound in
late stage development for enlarged prostate (BPH) and for
localized prostate cancer. The aim of the study was to
determine the safety and clinical benefit fexapotide can provide to
men who were given a second injection of fexapotide for their
prostate enlargement (BPH). In the new study long-term
outcomes were determined 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. All treatment failures
were included in the analysis. Results have now shown that there
was 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.
"These prospective long-term study results in
reinjected patients clearly demonstrate that fexapotide leads to
clinically meaningful long-term symptomatic improvements in BPH
patients with minimal treatment, and without the worrisome and
bothersome toxicities of conventional BPH treatments such as
retrograde ejaculation, and increased cancer risk," said Dr. Paul
Averback MD, CEO of Nymox. "Our earlier reported Phase 3 studies
have shown that fexapotide reduces the long-term need for surgery
by up to 82-95% compared to approved conventional BPH treatments.
Data indicates that fexapotide shows significant efficacy against
prostate cancer as a therapeutic, and in addition has been shown in
Phase 3 to reduce the risk of prostate cancer when fexapotide is
used to treat BPH. This is in comparison to some conventional BPH
treatments in routine clinical use today which on the other hand
increase prostate cancer risk, and which have these many other well
known undesirable side effects,” he said.
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 has completed and fully financed 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. 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. The Company will publish the
findings of the fexapotide clinical trials in peer
review medical journals as well as in presentations
at medical and urological meetings.
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
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