Nymox Reports Successful New Long-Term Fexapotide Placebo Crossover Study Results: Major Reduction in Incidence of Surgery
August 24 2016 - 12:19PM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to
announce successful new study results from the
long-term blinded placebo crossover group from the
U.S. Phase 3 trials for fexapotide, the Company's lead
compound in late stage development for enlarged prostate (BPH) and
for localized prostate cancer. The aim of the study was to
determine the clinical benefit fexapotide can provide to men who
initially were double blind randomized to and received placebo,
remained blinded as to their placebo treatment, and who
subsequently required additional medical and/or surgical
treatment. In the new study long-term outcomes were determined
in 391 patients who were given double blind placebo injections,
which were followed by crossover to other treatments at the
patients' discretion. The numbers of blinded placebo patients who
subsequently received surgical treatment during the next 2-3 years
for their BPH symptoms were then prospectively analyzed. Results
have now shown that there was 82-95% reduction in the number of
these patients who required surgery after they received crossover
fexapotide in the trial, as compared to patients who did not
receive fexapotide but instead received crossover conventional
approved BPH treatments (p<.0001).
“These exciting results from this long-term
prospective analysis confirm what I and other researchers have
consistently seen in the clinic -- that it is obvious that
fexapotide greatly helps patients in terms of symptomatic
benefit for their BPH; and with these results, the clinical
benefit also results in much less need for surgical intervention
over the long-term. I believe these clinical results, combined with
previously reported incidence and progression of prostate cancer in
this patient population are truly
important. Furthermore, the extreme safety of this
new drug and the lack of sexual side effects are remarkably helpful
for patients,” said Dr. Mo Bidair, Medical Director of San
Diego Clinical Trials in San Diego, CA and an Investigator who has
participated for many years in the Fexapotide Clinical Trials.
Nymox has completed and fully financed the
execution of seven Phase 3 U.S. BPH (prostate enlargement) clinical
protocols, including 2 prospective randomized multicenter single
injection double blind clinical trials; 2 U.S. repeat injection
clinical trials; and 3 U.S. blinded long-term clinical trial
extension studies. In addition, a number of Phase 3 safety and
clinical pharmacology studies and analyses have been completed. The
Company expects to file for approvals in the next 1-2
quarters. The Company also expects to report further
analyses and results when available in the near future. The
Company will publish the findings of the fexapotide clinical trials
in peer review medical journals as well as in
presentations at medical and urological meetings.
“These prospective study results in blinded
placebo crossover patients clearly demonstrate that fexapotide
reduces the long-term need for surgery by 82-95% compared to
approved conventional BPH treatments”, said Dr. Paul Averback MD,
CEO of Nymox. “Fexapotide shows significant efficacy against
prostate cancer as a therapeutic, and in addition has been shown to
reduce the risk of prostate cancer when fexapotide is used to treat
BPH. This is in stark contrast to some conventional BPH treatments
in routine clinical use today which on the other hand increase
prostate cancer risk, and which have many other well known
undesirable side effects,” said Dr. Averback.
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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