Nymox Announces Positive New Prostate Cancer Clinical Trial Results
May 06 2014 - 10:00AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today new
positive outcome results from the Company's ongoing prospective
trial of NX-1207 for the treatment of low grade localized prostate
cancer. These are the first clinical patient treatment outcome
results for this trial. A controlled comparison was conducted
of patients who required and received radiation and surgery
treatments for their cancer based on blinded post-treatment
upgraded evaluations of their pre-treatment initially positive
lower grade cancers. The study found after up to 22 months for
NX-1207 single-injection treated patients there was an 85%
reduction compared to controls in the proportion of patients who
had upgraded blinded biopsy results in the treated area and went on
to require and receive radiation therapy and/or prostatectomy
(surgery).
Long-term clinical outcome is considered to be a highly
important measure of drug treatment efficacy. 146 patients were
enrolled in the NX03-0040 Phase 2 U.S. trial and either randomized
to one of two doses of NX-1207 (2.5 mg or 15 mg) or to active
surveillance (no treatment). The drug was injected into the area of
the prostate where the cancer was detected and repeat biopsies were
then performed on all patients, treated and controls. Follow-up
studies are being conducted of all patients in the study to monitor
outcome and safety data. The patients in the new study results
were followed for up to 22 months post-treatment.
Previously reported study results showed that patients with
NX-1207 treatment had significantly less Gleason grade progression,
lower average PSA levels, lower numbers of biopsy cores showing
greater malignancy, and lower total volume of more malignant cancer
compared to controls.
To date, NX-1207 has had an excellent safety profile as both a
treatment for benign prostatic hyperplasia (BPH) and localized
low-risk prostate cancer. In the current trial, a new high dose of
drug (15 mg) was safely used without drug-related adverse effects.
NX-1207 has shown safety in repeat injection studies (NX02-0020 and
NX02-0022). The drug does not lead to immune responses such as
antibody formation which can cause significant drug toxicity and/or
limit usage to single treatments due to drug neutralizing
effects.
Paul Averback MD, CEO of Nymox, said, "These new results show
the potential of NX-1207 to offer men with low-risk prostate cancer
a significant tangible benefit in terms of avoidance of radiation
and/or surgery and the related risks, discomforts, and permanent
side effects. We emphasize that these results are based on a single
injection only. A similar convenient treatment regimen with
multiple injections is to be expected to offer even more benefit,
which we hope to be able to demonstrate as soon as possible. If
these positive results can be further validated, NX-1207 may prove
to offer a new safe option for a painless way to deal with a major
problem for many men."
NX-1207 is in Phase 3 development in the U.S. and Europe for
benign prostatic hyperplasia (BPH) also referred to as prostate
enlargement, a common affliction of middle-aged and elderly men,
affecting up to half of men over the age of 50. The Company's
European partner for BPH is Recordati S.p.A.
More information about Nymox is available at www.nymox.com,
email: info@nymox.com, or 800-936-9669.
This press release contains certain "forward-looking statements"
as defined in the United States Private Securities Litigation
Reform Act of 1995 that involve a number of risks and
uncertainties. There can be no assurance that such statements will
prove to be accurate and the actual results and future events could
differ materially from management's current expectations. Such
factors are detailed from time to time in Nymox's filings with the
United States Securities and Exchange Commission and other
regulatory authorities.
CONTACT: Brian Doyle
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com
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