Nymox Announces Phase 3 BPH Studies
April 01 2015 - 10:00AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today that
the Company is undertaking further analyses of its pivotal U.S.
Phase 3 studies of NX-1207 for prostate enlargement (BPH). This
will include new long-term data from Studies NX02-0017 and
NX02-0018. The Company expects to provide these new pivotal Phase 3
study results in Q2 or early Q3 this year.
The pivotal U.S. studies NX02-0017 and NX02-0018 were initiated
in 2009. Enrollment of NX02-0017 (499 patients randomized) was
completed in 2012; enrollment of NX02-0018 (498 patients
randomized) was completed in 2013. 973 patients were injected with
either NX-1207 2.5 mg (n=582) or saline vehicle alone as control
(n=391). At 12 months post-treatment there was no overall top-line
statistical significance for the efficacy of treatment in terms of
BPH Symptom Score improvement vs controls. The safety profile of
NX-1207 was excellent.
Dr. Paul Averback, CEO of Nymox said, "Despite the setback of
top-line results not initially beating controls statistically at 12
months post-treatment in these large studies, we continue to
believe that NX-1207 has enormous potential for long-term
management of BPH. Additional new blinded protocol data from the
same pivotal studies is being prospectively captured in order to
assess long-term results in patients up to 5 years after a single
injection of NX-1207 2.5 mg vs placebo."
NX-1207 is also in late-stage development for low grade
localized prostate cancer. In 2014 the Company reported 8 month
efficacy results showing statistically significant reduced cancer
progression in patients who received NX-1207 compared to standard
of care.
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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