Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is pleased to
provide a current January 2020 update on several important
corporate activities and achievements since the last update in
October 2019.
The Company recently received the necessary
information regarding the formatting and content of its upcoming
regulatory filings for its Fexapotide Triflutate (FT) first in
class injectable drug to treat the symptoms of prostate enlargement
(BPH) in men. The Company is proceeding to integrate safety data
from its four Phase I and Phase II BPH clinical trials as well as
the safety data from Prostate Cancer Study NX03-0040 into the final
dataset (that also includes 4 Phase 3 trials) that will be part of
the New Drug Application (NDA) submission. The filings seeking
approvals in the US and in Europe are now targeted for the first
half of 2020 in both jurisdictions. At this point, the Company does
not have any barriers to report and does not expect any delays.
Nymox is further pleased to report that another
peer review publication (as anticipated in the Company’s October
21, 2019 Press Release) was recently accepted and published in
Research and Reports in Urology. This publication discusses the
selective cellular ablation capabilities of Fexapotide Triflutate
to induce apoptosis (natural cell death) in prostate glandular
cells which are a major part of the prostate enlargement which
defines benign prostatic hyperplasia. Selective pharmaco-ablation
is achieved while leaving the nerve cells and urethra and other
nearby tissues (all crucial for normal sexual function) unaffected.
In fact, the Company has previously reported a statistically
significant improvement in sexual function reported by men treated
with FT for BPH in its U.S. Phase III long-term follow up
studies.
A fourth new and important peer review article
is expected to appear in the near term. Further information will be
provided when the new article appears.
Dr Paul Averback, CEO commented, "We are very
pleased to provide these positive substantiated updates to
shareholders today. Now, after many months of intensive work with
our regulatory advisors and experts, we are confident that we have
the needed clarity concerning the optimal formatting and content
protocols being undertaken. The Company is currently highly focused
on expeditiously completing the final legs of its regulatory
pre-filing responsibilities.”
The new peer review article reported in January
2020 and published in Research and Reports in Urology provided
detailed documentation of the selective pharmco-ablation mechanism
of action of FT, demonstrating the highly selective reduction of
prostate cells which comprises one of the most important underlying
reasons for the highly superior safety and efficacy of
Fexapotide.
According to the new paper, "a traditional major
challenge for treatment has been to promote or to directly produce
tissue destruction that is structurally selective at the
microscopic (histological) level, in order to avoid undesirable
toxicities and irreparable damage to key adjacent structures. For
example, transurethral resection, high energy laser extirpations
and other methods may damage prostatic nerves and peri-urethral
musculature, with the consequent occurrences of ejaculatory
disorders, sexual dysfunction and /or incontinence."
The article further states, “this is the first
demonstration of a molecular treatment that can produce
structurally significant and focally targeted destruction of
prostate epithelial gland growth combined with complete or near
complete preservation of key nerves and structural elements in
intimate structural proximity to the foci of ablation.”
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
Danielsen
Nymox Pharmaceutical Corporation1-800-93NYMOXwww.nymox.com
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