Nymox Prostate Cancer Drug Treatment Trial Nears Completion
September 26 2013 - 9:45AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today that
enrollment in the company's NX03-0040 US Phase 2 clinical trial of
NX-1207 for localized prostate cancer is nearing completion with
over 80% patients now enrolled. Based on current screening and
enrollment rates, the company anticipates that enrollment will be
completed in the near future. Initial top line study results are
expected to be available approximately 2 months after completion of
enrollment.
The NX03-0040 study involves 150 patients with low grade
localized prostate cancer who are randomized to low or high dose
NX-1207 or to control (active surveillance with no drug or surgical
or radiation treatment). Patients undergoing active surveillance in
the trial also have the opportunity to receive NX-1207 after
completion of their active surveillance portion of the trial.
The NX03-0040 study assesses the safety and efficacy of NX-1207
in eradicating or shrinking low grade localized prostate cancer
tumors by multiple clinical and laboratory measurements and blinded
prostate biopsies at 6 weeks after treatment. Initial top-line
results from trial NX03-0040 will be available soon after
completion of the post-treatment biopsy assessment of the last
patient randomized to drug.
Safety assessments of patients treated to date have been
positive with no serious or unexpected adverse effects related to
the drug, based on ongoing monitoring and safety committee
reviews.
In the study, NX-1207 is administered directly into the area of
the prostate where the cancer was detected. The drug treatment is
performed by a urologist in an office setting, and does not require
anaesthesia, sedation, or catheterization. Treatment takes only a
few minutes and involves minimal discomfort to the patient.
About 1 in 6 men will be diagnosed with prostate cancer during
their lifetime. Most cases of prostate cancer are detected via
prostate-specific antigen (PSA) screening and are usually found as
localized tumors. Surgical removal of the prostate (radical
prostatectomy) and radiation therapy with or without androgen
deprivation therapy are the most common active treatment options
for localized prostate cancer but have significant short- and long-
term adverse effects, including impotence, urinary dysfunction, and
other complications.
NX-1207 is also in Phase 3 clinical trials in the U.S. and
Europe for the treatment of benign prostatic hyperplasia (BPH), one
of the most commonly diagnosed conditions in older men.
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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