Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is pleased to
report a new peer review research report has been published on
experimental studies of the Company's Fexapotide Triflutate
treatment for prostate enlargement (BPH) and low grade prostate
cancer. The article is entitled "Fexapotide triflutate induces
selective prostate glandular pharmaco-ablation in the rat" and it
is published in Research and Reports in Urology.
The research report presents data and scientific
evidence for how Fexapotide inhibits prostate enlargement by
selectively eliminating prostate glandular cells while preserving
key elements including nerves, blood vessels, and adjacent
structures. This exquisitely selective ablation mechanism is one of
several main reasons that Fexapotide has achieved its excellent
safety profile in human trials involving over 1700 injections of
Fexapotide and controls. Research and Reports in Urology is a very
highly respected international peer review journal of urological
research. The full peer review article is available online at
https://doi.org/10.2147/RRU.S231334.
According to the article, "These studies in the
rat have shown that FT intraprostatic administration consistently
leads to significant and selective prostate glandular epithelial
apoptotic cell loss and gland shrinkage, with the absence of
discernible damage to adjacent and surrounding tissues including
nerves, blood vessels and other important structures.
Gland-specific targeted molecular ablation of overgrown prostatic
glands in the transition zone in the prostate with nerve sparing is
a novel mechanism of action for a prostate therapeutic which has
important benefits. The nerve and stromal sparing for
peri-prostatic tissues provides an objective underlying basis for
the observed safety of FT treatment in human BPH studies."
The report concludes, "A major challenge for
prostate treatments has been to produce or promote beneficial
targeted gland destruction that is structurally selective at the
microscopic tissue level in order to avoid undesirable toxicities
and irreparable damage to important adjacent structures. Fexapotide
triflutate (FT) has been shown in human clinical trials to be a
well-tolerated pharmaco-ablative agent with therapeutic benefit in
patients with prostate enlargement and low-grade prostate cancer.
Evidence from experimental animal studies shows that FT leads to
prostate glandular cell loss not found in controls, by apoptosis
that is highly selective with sparing of nerves, vascular elements
and stroma, and near-total loss of glandular epithelium at 12
months."
The new report was authored by Paul Averback,
MD; Rajna Gohal, M.Sc, Marta Fuska, Kathleen Prins, and Ping Wang,
MD.
Nymox's lead drug Fexapotide (FT) has been in
development for over 10 years 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 977 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. FT has been shown to produce long-term
improvements in lower urinary tract symptoms associated with
prostate enlargement (BPH), a problem that afflicts an estimated
100 million or more men in the world. FT does not cause the
annoying side effects and risks found with available treatments for
BPH. FT is also in development for low grade prostate cancer.
A review article on the progress in the
development of Fexapotide entitled "Efficacy and safety of
fexapotide triflutate in outpatient medical treatment of male lower
urinary tract symptoms associated with benign prostatic
hyperplasia" authored by Neal Shore, MD, FACS (Carolina Urologic
Research Center, Myrtle Beach, SC); Ronald Tutrone, MD, FACS
(Chesapeake Urology Research Associates, Baltimore, MD); and Claus
G. Roehrborn, MD (University of Texas Southwestern Medical Center,
Dallas, TX) was published in Therapeutic Advances in Urology.
2019;11:1-16.
The clinical trial results for Fexapotide
treatment of BPH are published in the World Journal of Urology May
2018, Volume 36, pages 801–809
(https://doi.org/10.1007/s00345-018-2185-y) in a peer review report
entitled "Fexapotide Triflutate: Results of Long- Term Safety and
Efficacy Trials of a Novel Injectable Therapy for Symptomatic
Prostate Enlargement" authored by Neal Shore, MD, FACS (Carolina
Urologic Research Center, Myrtle Beach, SC); Ronald Tutrone, MD,
FACS (Chesapeake Urology Research Associates, Baltimore, MD);
Mitchell Efros, MD, FACS (Accumed Research, Garden City, NY);
Mohamed Bidair, MD (San Diego Clinical Trials, San Diego, CA);
Barton Wachs, MD (Atlantic Urology Medical Group, Long Beach, CA);
Susan Kalota, MD (Urological Associates of Southern Arizona,
Tucson, AZ); Sheldon Freedman, MD, FACS (Freedman Urology, Las
Vegas, NV); James Bailen, MD, FACS (First Urology, Louisville, KY);
Richard Levin, MD, FACS (Chesapeake Urology Research Associates,
Towson, MD); Stephen Richardson, MD (Jean Brown Research, Salt Lake
City, UT); Jed Kaminetsky, MD, FACS (University Urology, New York,
NY); Jeffrey Snyder, MD, FACS (Genitourinary Surgical Consultants,
Denver, CO); Barry Shepard, MD, FACS (Urological Surgeons of Long
Island, Garden City, NY); Kenneth Goldberg, MD, FACS (U T
Southwestern Dept of Urology, Lewisville, TX); Alan Hay, MD, FACS
(Willamette Urology, Salem, OR); Steven Gange, MD, FACS (Summit
Urology Group, Salt Lake City, UT); Ivan Grunberger, MD, FACS
(Brooklyn Urology, Brooklyn, NY).
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, 2018, and its Quarterly Reports.
For Further Information
Contact:Erik DanielsenNymox Pharmaceutical
Corporation1-800-93NYMOXwww.nymox.com
Nymox Pharmaceutical (NASDAQ:NYMX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Nymox Pharmaceutical (NASDAQ:NYMX)
Historical Stock Chart
From Apr 2023 to Apr 2024