Sexual Function Improves in First-Line Patients Given Fexapotide Treatment in Nymox U.S. BPH Long-Term Clinical Trials
May 31 2017 - 10:00AM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to
announce statistically significant clinical trial results showing
that the Company's prostate enlargement (BPH) and prostate cancer
drug Fexapotide Triflutate produced clinically important
improvements in sexual function in first-line patients who received
Fexapotide in the Company's U.S. long-term clinical trials.
Nymox has previously reported the absence of
significant sexual or other side effects from Fexapotide treatment
of prostate enlargement or prostate cancer based on 15 years of
clinical research in prospective randomized trials in the
U.S. However actual improvement in sexual function (which is
very different from absence of debilitating sexual side effects) is
a newly reported and important finding.
Patients in the Company's Phase 3 Fexapotide
U.S. trials were administered a validated standardized Sexual
Function Questionnaire (SFQ) at baseline, in the first 12 months,
and at long-term after a single injection in the Phase 3 pivotal
trials NX02-0017 and NX02-0018, and prior to re-injection in Phase
3 studies NX02-0020 and NX02-0022. The trial data demonstrated
several lines of prospective randomized double blind evidence
indicating sexual function improvement. At 12 months after
treatment in the first-line previous treatment-naive patients
(n=370), there was a statistically significant improvement from
baseline in Fexapotide treated subjects (p<.0001), while placebo
showed no improvement from baseline. In first-line previous
treatment-naive subjects with SFQ long-term assessments (12-51
months after treatment, n=156), the Fexapotide treated subjects had
statistically significant improvement compared to placebo. Placebo
treated patients at long-term showed worsening of sexual function
(mean -0.88 points) while Fexapotide treated patients showed
improvement (+0.64 points, p=.0049). The percentage of first-line
previous treatment-naive patients in the study with pre-existent
sexual dysfunction (baseline SFQ ≤3 points) who ended the study
improved and no longer with self-reported sexual dysfunction (SFQ
≥4 points) was statistically significant (p<.05) while there was
no change in the placebo group.
Paul Averback MD, CEO of Nymox said, "The
findings newly reported today add another important dimension to
the advantages of Fexapotide treatment for BPH. In addition to
absence of sexual side effects, there is now statistically
significant prospective clinical trial evidence of sexual
functional improvement in men with prostate enlargement given
Fexapotide."
Nymox has previously reported the absence of
significant sexual or other side effects from Fexapotide treatment
of prostate enlargement or prostate cancer based on 15 years of
clinical research in prospective randomized trials in the
U.S. In over 1700 individual treatments with Fexapotide
or placebo, there have been no significant side effects linked to
the drug, and no significant evidence of sexual side effects. This
is in marked contrast to traditional approved treatments for BPH.
Alpha blocker drugs and 5-alpha reductase inhibitor oral
medications for BPH are well known to commonly produce sexual and
other side effects that limit these older drugs' usefulness and
tolerability for patients. It is not uncommon for patients on oral
medications to suffer from chronic loss of libido, impotence,
ejaculatory dysfunction, and many other problems. Increased
prostate cancer risk has also been attributed to some of the older
approved medications. Surgical treatments for BPH are usually
effective for urination problems but permanent ejaculatory problems
such as retrograde ejaculation are common and surgical side effects
and pain can be distressing.
The sexual function improvement data for
Fexapotide will be presented in greater detail at medical meetings
in the U.S. later this year.
Fexapotide Triflutate is Nymox's first in class
injectable treatment 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.
On May 3, 2017 Nymox announced that it had filed
for marketing approval in Europe for Fexapotide Triflutate for the
treatment of prostate enlargement (BPH benign prostatic
hyperplasia).
Nymox's lead drug Fexapotide has been in
development for over 15 years and has been tested by expert
clinical trial investigative teams in over 70 distinguished
clinical trial centers throughout the US, and has been found after
7 years of prospective placebo controlled double blind studies of
treatment of 995 U.S. men with prostate enlargement 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 same clinical program has also shown
in a long-term blinded placebo crossover group study an 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).
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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