Nymox Reports Long-Term Prostate Cancer Results in 7 Year Prospective Study of 995 U.S. Middle-Aged and Elderly Men Without C...
22 June 2016 - 11:30PM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) announced today
results from the Company's 7 year prospective placebo controlled
double blind studies of treatment of 995 U.S. men with the
Company's lead drug fexapotide. Men who received fexapotide showed
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 men in the study received fexapotide or
placebo for the treatment of their prostate enlargement (BPH)
symptoms. All men were thoroughly evaluated to exclude any prostate
cancer prior to qualifying for enrollment in the studies. The
participants were enrolled at 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.
"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 today 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.
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 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.
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 reported today will add to
the evidence in fexapotide's favor towards our goal of widespread
major benefit for middle-aged and elderly men."
Dr. Averback added, "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."
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 Apr 2024 to May 2024
Nymox Pharmaceutical (NASDAQ:NYMX)
Historical Stock Chart
From May 2023 to May 2024