Nymox Announces Prostate Cancer Clinical Trial Results From Completed 18 Month Endpoint Study
February 09 2016 - 10:00AM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) today announced
results from the completion of the Company's U.S. 40 month (18
month outcomes) localized prostate cancer Phase 2 NX03-0040
clinical trial of fexapotide triflutate (NX-1207). The study
successfully met its pre-determined endpoints. Cancer progression
clinical outcomes were significantly improved in the fexapotide
treated patient groups.
The clinical trial commenced in February 2012 at
28 U.S. investigational clinical trial sites and enrolled 147
patients with low grade localized (T1c) prostate cancer. The study
lasted 40 months overall from the first patient randomized to the
last patient 18 month endpoints.
Results from the completed 18 month outcome
study after a single injection of fexapotide included the
following:
- Absence of tumors (Primary Endpoint) controlled for size in
baseline area: fexapotide 15 mg superior to control (p=.035);
crossover fexapotide 15 mg superior to control (p=.002); crossover
fexapotide overall superior to control (p=.014).
- 75.5% reduction in biopsy proven prostate cancer Gleason
upgrades (pathological progression) after 18 months in fexapotide
15 mg treated patients compared to control (p=.0055). 71.7%
reduction in prostate cancer Gleason upgrades in fexapotide treated
patients overall (p=.0045 vs controls).
- 84.8% reduction after 18 months in surgery or radiotherapy
instituted for prostate cancer Gleason upgrade (biopsy worsening)
in fexapotide treated patients overall compared to control group
(p=.014).
- 54.8% reduction after 18 months in surgery or radiotherapy
instituted for all causes with or without prostate cancer Gleason
upgrade in fexapotide 15 mg treated patients compared to control
(p=.026).
- Significant improvement for fexapotide patients compared to
controls in 4 out of 4 Secondary Endpoints. Tumor volume reduction
in the treated area, combined dosages (p=.04); tumor volume change
in prostate overall, fexapotide patients overall (p=.014); median
tumor grade outcome in the treated area, all dosages (fexapotide
median benign, vs control median Gleason 3+3), and superior median
tumor grade in prostate overall, fexapotide 15 mg vs
controls.
- Consistent safety results with no significant drug-related
adverse events and no significant related sexual adverse
events.
- Overall superior results for the fexapotide 15 mg dose compared
to the 2.5 mg dose (dose-response).
- Other statistically significant improvement outcomes in
fexapotide patients compared to controls, to be presented
comprehensively at medical meetings.
"These results demonstrate that a single
targeted office injection of fexapotide has led to statistically
significant improvement in outcomes with much less surgery or
radiotherapy required after 18 months. This means a reduction in
patient discomfort, and a reduction in permanent side effects and
life changes when the more invasive treatments are required," said
Paul Averback, CEO of Nymox.
Dr. Averback added, "Based on these outcomes, we
believe there are exciting potential patient benefits from one or
more painless fexapotide office injections for this common and
distressing condition."
The Company will report at a later date
concerning its plans for moving the compound forward toward the
market for this important medical problem.
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, 2014, and its Quarterly Reports.
Paul Averback
Nymox Pharmaceutical Corporation
800-93NYMOX
www.nymox.com
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