Nymox Announces New Prostate Cancer Clinical Trial Results
April 20 2015 - 10:00AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today
long-term clinical trial results from the Company's NX-1207 Phase 2
prostate cancer study NX03-0040. The new results demonstrate
statistically significant (p=.0067) better outcomes at up to 2.8
years for NX-1207 treated patients compared to controls. Trial
participants included 146 patients with low grade localized
prostate cancer at 44 U.S. investigational sites.
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 that after up to 2.8 years for NX-1207 single-injection
treated patients there was a 68.2% 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) (p=.0067). The new
study also found that all instances of surgery or radiation,
including elective cases without upgrades, were decreased by 62.7%
(p=.0035) in NX-1207 patients compared to the randomized control
group.
Long-term clinical outcome is a highly important measure of drug
treatment efficacy. Patients were randomized to one of two doses of
NX-1207 (2.5 mg or 15 mg) or to active surveillance (control). The
drug was injected into the area of the prostate where the cancer
was detected and repeat biopsies, serial PSA measurements and
long-term follow-up were performed on all patients treated and
controls.
Paul Averback MD, CEO of Nymox said "These new results show the
potential of NX-1207 to offer men with the most common form of
low-grade prostate cancer a significant tangible benefit in terms
of avoidance of radiation and/or surgery and the related risks,
discomforts, and permanent side effects. The results show a
significant positive effect from a single painless injection which
is very exciting."
To date, NX-1207 has had an excellent safety profile. NX-1207
has shown safety in 9 clinical trials (BPH and prostate cancer)
including repeat injection studies. 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.
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.
Prostate cancer is the most commonly diagnosed cancer in men,
other than skin cancer, and is the second leading cause of cancer
death for men. Approximately 50% of newly diagnosed prostate
cancers are initially considered low risk.
For more information please contact 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.
Development of drug products involves substantial risks and actual
results may differ materially from expectations. Factors that could
cause actual results or events to differ materially from those
projected in forward-looking statements are detailed from time to
time in Nymox's filings with the United States Securities and
Exchange Commission and other regulatory authorities.
CONTACT: For Further Information Contact:
Paul Averback
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com
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