Nymox Announces Completion of Enrollment for Second BPH Re-Injection Study
15 July 2014 - 11:30PM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today the
closing of enrollment for Study NX02-0022, the Company's second
re-injection Phase 3 clinical trial of the safety and efficacy of
NX-1207 for the treatment of enlarged prostate (benign prostatic
hyperplasia or BPH). The NX02-0022 study enrolled patients who had
previously participated in an earlier NX-1207 BPH study, and in the
new trial these men received a second open-label injection of
NX-1207. The study used a new lyophilized formulation of NX-1207
that has longer stability stored at room temperature.
An interim analysis of the new efficacy data from the NX02-0022
study will be reported within the next few weeks.
In the first reported NX-1207 reinjection NX02-0020 study, mean
overall symptomatic improvement in the AUA BPH Symptom Score in
treated patients was 7.6 points (p<.001). Each patient had
received either one or two injections of NX-1207 with the mean
duration from the initial injection to the final assessment of 26
months.
NX-1207 is currently being assessed in 5 Phase 3 and one Phase 2
clinical trials. Data verification and auditing procedures are in
progress for the Company's U.S. clinical trials NX02-0017 and
NX02-0018 which have completed enrollment and patient
participation. Unblinding and top line analysis of efficacy and
safety data will be conducted and reported once these procedures
have been concluded. In Europe, patient recruitment is ongoing at
investigational sites in European countries in a large pivotal
Phase 3 blinded comparator controlled clinical trial under the
sponsorship of the Company's European licensing partner, Recordati
S.p.A.
BPH is one of the most commonly diagnosed diseases of middle
aged and elderly men. The condition can have a significant negative
impact on a man's health and quality of life and can lead to
urinary retention, incontinence and other serious consequences. It
is estimated that 50% of men in their 50s have pathological signs
of prostatic hyperplasia and over 25% of men over the age of 40
suffer from moderate to severe urinary symptoms and associated
problems 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: Brian Doyle
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com
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