NYMOX Files For Marketing Approval For Fexapotide Triflutate in Europe
May 03 2017 - 9:30AM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to
announce today that the Company has filed to seek approval for
marketing authorization for Fexapotide Triflutate in five European
countries, comprising the Netherlands, the UK, Germany, France and
Spain. This first filing for Fexapotide Triflutate is for the
indication of treatment of the symptoms of BPH (benign prostatic
hyperplasia; prostate enlargement).
"Fexapotide has the real potential to alter the
way BPH will be treated in the future. There is a major unmet
medical need for a safe and efficacious treatment method for the
many men who suffer from this age-related malady," said Dr.
Paul Averback, CEO of Nymox.
"This first filing represents a major corporate
milestone for the development of Fexapotide. We are extremely
pleased to achieve this milestone which is based on intensive work
carried out by our teams and many expert collaborators over the
past 15 years," Dr. Averback added.
Erik Danielsen, Nymox's CFO added, "Going
forward, we expect to announce further
regulatory filings for approval in additional important
jurisdictions around the world as well as corporate initiatives
supporting our pre-commercialization efforts. We now plan to
significantly step up our communication programs with both
the medical as well as the financial communities. Today's
important step forward will be followed up by additional strategic
business development activities."
Fexapotide has been in development by Nymox for
15 years. Clinical trials have shown long-term symptomatic
improvement, long-term reduction in the need for BPH surgery,
long-term reduced prostate cancer risk, and an excellent long-term
safety profile with no sexual side effects in comparison to
available drug treatments. Fexapotide Triflutate is administered at
an office visit and consists of a single painless injection that
takes a few minutes or less, with no requirements of anesthesia, or
analgesia or catheterization. There are none of the typical sexual
and other distressing side effects seen with conventional BPH
treatments.
BPH is highly prevalent in middle aged and
elderly men, affecting millions of men world-wide. Existing medical
treatments for BPH generally provide temporary relief only, and are
commonly discontinued by patients due to side effects and little
efficacy. Surgical treatments are effective but often have
permanent retrograde ejaculation as a result, and other problems
and risks are associated.
Nymox will hold a teleconference call for
shareholders next week. Further details regarding the
teleconference will be announced in advance of the call.
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 Averback
Nymox Pharmaceutical Corporation
800-93NYMOX
www.nymox.com
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