Nymox Application Validated:
September 14 2017 - 12:40PM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to
announce today that the European Member States for Nymox's
Marketing Authorization Application (MAA) for Fexapotide Triflutate
for the treatment of benign prostatic hyperplasia (BPH, prostate
enlargement) have accepted the Company’s MAA. With this validation,
the Nymox application is complete and regulators from the member
countries formally acknowledge that the Company has
provided the requested documentation necessary for the MAA to be
reviewed.
"With the acceptance of the MAA, the Member
States officially acknowledge that the Company has provided all the
required information and documentation necessary for the formal
review process. The acceptance of this MAA is an important
milestone in our goal to bring this first in class treatment
candidate to countless men suffering from the symptoms of BPH.
Nymox looks forward to working with European regulators to help
patients with BPH attain the benefits that treatment with
Fexapotide Triflutate may offer." said Dr. Paul Averback, CEO of
Nymox.
Fexapotide Triflutate is Nymox's first in class
injectable treatment candidate for BPH and low grade localized
prostate cancer. The drug is given as a virtually painless
injection with no anesthesia, analgesia or catheterization, and is
an office procedure which takes a few minutes to administer.
Fexapotide has been in development for over a
decade and has been found in trials 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. The clinical program has also shown in long-term
studies >80% reduction in the number of crossover Fexapotide
treated patients who required surgery for their BPH as compared to
patients who received crossover conventional approved BPH
treatments. Fexapotide led to long-term improvement in sexual
function as reported by first-line patients who received the new
drug.
BPH is extremely common and afflicts middle aged
and elderly males, affecting millions of men worldwide with chronic
lower urinary tract symptoms, and often requires surgical
treatments.
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.
Contact:Paul AverbackNymox
Pharmaceutical Corporation800-93NYMOXwww.nymox.com
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