Nymox Closes Recruitment for NX-1207 Phase 2 Prostate Cancer Trial
January 13 2014 - 10:00AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) today announced that
recruitment is being closed for the Company's Phase 2 study of
NX-1207 for low risk localized prostate cancer (NX03-0040) and that
enrollment will be formally completed shortly. Initial top line
study results are expected to be available approximately 6-8 weeks
after completion of enrollment.
The NX03-0040 study involves approximately 150 patients with low
grade localized prostate cancer who are randomized to low or high
single 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 a single
injection 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.
The American Cancer Society estimates that in 2012 more than
240,000 men in the United States will be newly diagnosed with
prostate cancer and more than 28,000 men will die from the disease.
Most cases are detected via prostate-specific antigen (PSA)
screening and usually found to have 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 late stage Phase 3 development in the U.S.
for the treatment of benign prostatic hyperplasia (BPH), a common
condition of older men associated with growth in prostate size as
men age. NX-1207 is in Phase development in Europe sponsored by
Recordati S.p.A., the company's European licensing partner for the
NX-1207 BPH indication.
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: For Further Information Contact:
Brian Doyle
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com
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