Nymox Announces Completion of Patient Enrollment in Final Pivotal U.S. Phase 3 BPH Study
May 03 2013 - 11:47AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today
completion of patient enrollment in the Company's final pivotal
U.S. Phase 3 NX02-0018 Study of NX-1207 for BPH. This study is now
closed to further enrollment. Top-line results from the large Phase
3 Study are expected in early 2014.
Paul Averback MD, CEO of Nymox said, "Our drug development
programs for NX-1207 include 6 large important studies in the U.S.
and Europe, and other clinical and non-clinical research
activities. Final completion of enrollment in this last major
pivotal U.S. study is an important milestone in the NX-1207
development pathway. We look forward to reporting further
news."
NX-1207 is 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.
The drug has successfully completed a series of blinded controlled
multi-center U.S. clinical trials where a single dose of NX-1207
has been found to produce on average symptomatic improvements about
double that reported for currently approved BPH drugs without
causing the sexual or cardiovascular side effects associated with
those drugs. Follow-up studies have shown evidence of long lasting
benefit with a significant proportion of men who received a single
dose reporting maintained improvement in BPH symptoms without other
treatments for up to 7½ years. NX-1207 is injected by a urologist
in an office setting and involves little or no pain or discomfort.
Phase 3 trial activities of NX-1207 for BPH have begun in Europe
sponsored by Recordati S.p.A., the company's European licensing
partner.
NX-1207 is also being evaluated for the treatment of low risk
localized prostate cancer where NX-1207 is administered directly
into the area of the prostate where the cancer was detected. A U.S.
Phase 2 study (NX03-0040) for that indication is in progress.
BPH causes progressive difficulties with urination, such as
nocturia, urge to void frequently, acute urinary retention and
other problems. The condition can seriously impact the health and
quality of life of middle aged and older men. It is estimated that
50% of men in their 50s have pathological signs of prostatic
hyperplasia and a high proportion of men as they age suffer from
moderate to severe urinary problems and symptoms associated with
BPH.
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:
Roy Wolvin
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com
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