Nymox Reports Results of Prospective Cross-Over Study of Fexapotide Treatment for Prostate Cancer
October 29 2015 - 10:31AM
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported today that
long-term randomized cross-over data from the Company's trial
of fexapotide triflutate for low grade localized prostate cancer
has shown statistical significance in efficacy compared to
controls. The study results indicate that randomized control
subjects who subsequently switched to fexapotide had long-term
outcomes significantly superior to control patients who did not
change (cross-over) to fexapotide treatment.
These results are the initial 18 month follow-up results for the
fexapotide trial for prostate cancer to be reported. The cross-over
study arm of NX03-0040 consisted of 35 subjects. Based on biopsy
progression the proportion of patients who progressed on biopsy and
required biopsy progression-related surgery or radiotherapy in the
cross-over group (0%) at 18 months was significantly less than in
the control group (p<.03).
The cross-over group patients received randomized fexapotide 15
mg or 2.5 mg in a single treatment targeted toward the positive
baseline cancer focus identified in initial positive biopsies.
There were no cases in either of the 2 fexapotide dosage level
treatment groups with biopsy progression at 18 months
(p<.03).
In addition to the positive clinical progression results, the
primary endpoint of the study (re-biopsy absence of tumor in the
initially positive biopsy baseline area of the prostate) also
reached statistical significance (p<.03) in the cross-over
study. At the 18 month assessments, the post-treatment biopsy taken
from the treated area of the prostate which was initially positive
at baseline, showed absence of tumor (tumor presence in re-biopsy
of baseline positive focus n=0) in the cross-over treated patients,
which was statistically significant compared to controls
(p<.03).
The Company expects to report results from its long-term
NX03-0040 low grade localized prostate cancer study in the fourth
quarter.
One of the major problems with current prostate
treatments for localized prostate cancer (radical prostatectomy,
external beam radiation, or brachytherapy) is the relatively high
incidence of reported sexual dysfunction post-treatment. In 9
studies, NX-1207 treatment has been shown to have no significant
adverse effect post-treatment on sexual function or testosterone
levels.
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.
Contact:
Paul Averback
Nymox Pharmaceutical Corporation
800-93NYMOX
www.nymox.com
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