Nymox Provides Update on NX-1207 Phase 3 BPH and Phase 2 Prostate Cancer Clinical Trial Activities
January 28 2014 - 11:30AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) today provided
updates on pivotal Phase 3 development activities for NX-1207, the
Company's Phase 3 drug for benign prostatic hyperplasia (BPH), a
common affliction of older men. NX-1207 is also in development in
Phase 2 for localized prostate cancer. The Company's two large
pivotal prospective double blind placebo-controlled U.S. clinical
trials (NX02-0017 and NX02-0018) have completed enrollment. One
open label safety study (NX02-0020) of subjects who have received a
second injection of NX-1207 has completed enrollment and 6 month
data has been reported previously. A second open label reinjection
study (NX02-0022) is in progress. In Europe, patient recruitment is
ongoing at investigational sites in five major European countries
in a Phase 3 blinded comparator-controlled clinical trial under the
sponsorship of the Company's European licensing partner, Recordati
S.p.A.
Patient participation in the NX02-0017 U.S. pivotal Phase 3 BPH
study is completed. Patient participation in the second U.S.
pivotal trial, NX02-0018, will be completed in Q2 2014. Upon
completion of patient participation and blinded data verification
and monitoring procedures and auditing activities, unblinding and
data analyses of the two pivotal studies will commence at the
appropriate time in Q2 2014 with top line results being reported
expeditiously when available.
NX-1207 is being evaluated in a large U.S. Phase 2 study of
localized low-grade prostate cancer (NX03-0040), involving
approximately 150 subjects. Recruitment for the study is now closed
and results from the study are expected end of Q1 or early Q2
2014.
BPH is one of the most commonly diagnosed diseases in older men.
The condition can have a significant negative impact on a man's
health and quality of life and can lead to acute urinary retention,
incontinence and other serious consequences. It is estimated that
50% of men in their 50s have pathological signs of prostatic
hyperplasia and from 26 to 46% of men between the ages of 40 to 79
years suffer from moderate to severe urinary problems and symptoms
associated with BPH.
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.
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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