Fexapotide BPH Phase 3 Clinical Trial Results Published in World Journal of Urology
January 30 2018 - 8:30AM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reports today that
the results of Phase 3 clinical studies of Fexapotide Triflutate
undertaken from 2009-2016 are now published in World Journal of
Urology.
The article is entitled "Fexapotide Triflutate:
Results of Long-Term Safety and Efficacy Trials of a Novel
Injectable Therapy for Symptomatic Prostate Enlargement" and is
authored by 17 leading U.S. urologists:
- 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).
The full peer review publication is available
online on the World Journal of Urology’s website.
World Journal of Urology is a prestigious
top-tier international peer review journal specialized in clinical
urology.
According to the new publication, "In
conclusion, data from these 4 U.S. studies show statistically
significant long-term improvement in BPH symptoms and objective
outcomes including significant reduction in spontaneous AUR as well
as the addition of BPH surgery;” and “FT is well tolerated with an
excellent safety profile. Hence, FT is a safe and efficacious
clinic based treatment for BPH involving an intraprostatic
injection that requires only a few minutes to administer, with no
catheter nor anesthesia requirements. FT injectable represents a
novel, first in class BPH treatment modality."
The lead author of the article, Dr. Neal Shore,
said, "FT represents a new first in class
treatment for patients with lower urinary tract symptoms
and BPH. FT administration via direct intraprostatic injection
is ideally suited for the urology clinic. The collective trial
data demonstrates both short and long-term safety for FT; moreover,
the long-term efficacy data demonstrates its major
potential as an alternative to conventional daily oral BPH
medications."
Dr. Ronald Tutrone, a co-author of the report,
said, "The co-authors and urologists with whom I have spoken and
who have attended presentations of data are very impressed with the
results. I personally know of countless patients who will benefit
from this new, non-surgical treatment."
Reprints of the article will also be available
later from Nymox upon request after reprints become available from
the publisher.
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 recent sectional Annual
Meetings in 2017 in Scottsdale, AZ (North Central AUA November 15,
2017); Havana, Cuba (New York AUA November 6, 2017); Naples, FL
(South Central AUA November 27, 2017) and Savannah, GA
(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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