Nymox Reports 5-Year Results From Prospective Randomized Controlled Prostate Cancer Study of Fexapotide Triflutate in 146 U.S...
January 22 2018 - 11:30AM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported today
top-line 5-year results from Nymox's U.S. Study NX03-0040. Study
NX03-0040 was undertaken starting in 2012 at 44 investigational
sites across the U.S. comprising a highly representative sample of
146 men with the biopsy confirmed diagnosis of T1c prostate cancer,
which is the most common type of low grade localized prostate
cancer. After 5 years, the study has now shown that high dose
Fexapotide 15mg single dosage treatment resulted in 80% less
surgery or radiotherapy associated with Gleason grade progression
(p=.0003), and that both doses of Fexapotide (15mg and 2.5mg) were
consistently effective (p=.0003). There were 4.4% patients in the
entire Fexapotide group who showed increase in their Gleason
primary pattern grade in the 5-year study, compared to controls
where the incidence of grade 4 or higher primary pattern was 23.5%,
a reduction of 81.3% (p=.0061).
Paul Averback MD, CEO of Nymox, said, "These major
new results show the beneficial long-term effect of a single
injection of Fexapotide Triflutate. The results are expected to be
even better with regimens of additional or multiple treatment
administrations if required."
In the studies Fexapotide triflutate was
administered by a single painless injection directly into the
prostate requiring several minutes or less in an office procedure
guided by routine ultrasound. The drug was injected into the area
of the prostate where the cancer was previously detected prior to
enrollment in NX03-0040; and repeated biopsies every 18 months,
serial PSA measurements and long-term follow-up were performed on
all consenting treated patients and controls. After 5 years of
study, high dose Fexapotide 15mg single treatment resulted in 80%
less surgery or radiotherapy associated with Gleason grade
progression (p=.0003), and both doses of Fexapotide (15mg and
2.5mg) were consistently effective (p=.0003). There were 4.4%
patients in the entire Fexapotide group who showed increase in
their Gleason primary pattern grade in the 5-year study, compared
to controls where the incidence of grade 4 or higher primary
pattern was 23.5%, a reduction of 81.3% (p=.0061). The new study
results also indicated that after 5 years of study, all recorded
instances of surgery or radiotherapy, including elective cases
without Gleason upgrades, were decreased by 69.8% (p=.0002) in
Fexapotide 15mg treated patients compared to the randomized control
group.
Dr. Averback added, "Eight years of other related
U.S. long-term Phase 3 BPH studies of Fexapotide have shown
reduction in new prostate cancer incidence to 1.2%, compared to
previous large BPH studies of earlier drugs where the incidence of
prostate cancer is in the 10-20% range. There are therefore 2
different long-term Fexapotide programs which have now each
independently shown that Fexapotide has a significant and highly
beneficial effect for men with prostate cancer."
"These strong results clearly support Management's
ongoing efforts to advance both of the Company's 2 major projects
towards marketing goals. Nymox expects to report further on
its U.S. development plans for registration trials for low grade
prostate cancer. There is a global unmet medical need for more
effective prostate treatments without the undesirable side effects
of current treatments,” he said.
One of the major problems with the main current
prostate treatments for localized prostate cancer (radical
prostatectomy, external beam radiation, brachytherapy) is the
relatively high incidence of serious sexual problems
post-treatment. In 9 studies, Fexapotide treatment has been shown
to have a negligible significant adverse effect post-treatment on
sexual function or testosterone levels.
Prostate cancer is the most commonly diagnosed
cancer in men, other than skin cancer, and is the second leading
cause of cancer death for men. Approximately 50% of prostate
cancers are initially considered low risk.
Fexapotide has shown significant long-term benefit
for prostate enlargement (benign prostatic hyperplasia, BPH). The
recent results of Phase 3 studies of Fexapotide for BPH were
communicated in podium and symposium presentations to the American
Urological Association at four sectional Annual Meetings in 2017 in
Scottsdale (North Central AUA November 15, 2017), Havana, (New York
AUA November 6, 2017), Naples (South Central AUA November 27,
2017), and Savannah (Northeastern AUA October 12, 2017). The
Company has filed for approval for Fexapotide in Europe for BPH for
prostate enlargement in 2017, and the filing was validated in
September 2017.
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, 2016, and its Quarterly Reports.
For Further Information
Contact:Paul AverbackNymox Pharmaceutical
Corporation1-800-93NYMOXwww.nymox.com
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