Nymox Announces Prostate Drug Progress
August 11 2016 - 10:28AM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to
announce major progress in the evidence for the safety and efficacy
of fexapotide, the Company's Phase 3 drug in the final stages of
development for prostate enlargement (BPH) and for low grade
prostate cancer. Fexapotide has completed 2 long-term large Phase 3
BPH studies in the U.S. No other new prostate drug injectable
currently in development has previously succeeded in enrolling and
completing a fully U.S. study close to the size of either of
Nymox’s 2 long-term studies. In addition, no other injectable
prostate enlargement drug has previously been shown to have the
excellent long-term safety and efficacy profile of fexapotide.
Fexapotide treated BPH patients were shown to
have a remarkably low incidence of later development of prostate
cancer after up to 7 years of follow-up at top U.S. clinical trial
centers. The incidence rate was 1.3% which is a long-term finding
of major significance for the drug safety and efficacy. By
comparison, for example in a population of patients with erectile
dysfunction treated with PDE5 inhibitor drugs after 4 years the
rate of subsequent prostate cancer was 19.5% (and 22.7% in
controls) as recently reported in a large U.S. study published in
the Journal of Urology (Volume 196; 3, 2016). The quoted study was
in a population of middle aged and elderly men without prostate
cancer, similar to the Nymox study population.
Fexapotide will be filed for approval in the
next 1-2 quarters and the company envisages no significant new cash
needs for the pre-marketing development of fexapotide. The drug
will potentially be partnered for marketing with a larger company
if satisfactory terms can be negotiated. While there are other
companies with early stage drug candidates and/or drugs with
questionable results and worrisome safety issues such as
immunological reactions and common danger signs such as
frequent injection related fevers, Nymox has none of these problems
and considers there to be no competition for at least the next 5-10
years in this field because of the long times required to catch up
to Nymox. Another reason some potential competitors may fail is if
they are developing a biological, because this therapeutic market
is unlikely to support a drug which costs thousands of dollars per
dose to manufacture. Nymox has solved the above problems and
fexapotide is a drug with low manufacture cost, high projected
profit margin, and no known danger signs such as listed above. Most
importantly, the drug has completed 2 U.S. long-term studies which
have taken 7 years to complete and no competitor has completed even
their first fully U.S. study and therefore the field is at least
5-10 years behind.
Nymox also completed a 147 patient prospective
controlled prostate cancer study for low grade localized cancer.
After 18 months the fexapotide treated groups had statistically
significant better outcomes in terms of cancer progression than
controls. While some injectable candidates at other companies have
reported anecdotal results in two or three patients, Nymox found
similar or better results than the latter anecdotal reports even in
its untreated study controls. The Company considers that in this
category there is no other proprietary new injectable that has yet
been through a large clinical trial with any demonstrated
efficacy.
Nymox CEO Dr. Paul Averback commented "Our
extremely low cash requirements and strong, comprehensive
successful clinical trial results add up to a very strong position
for the Company's future. In this context we furthermore look
forward to reporting in the very near future on some additional new
clinical trial results for fexapotide."
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, 2015, and its Quarterly Reports.
Contact:
Paul Averback
Nymox Pharmaceutical Corporation
800-93NYMOX
www.nymox.com
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