Nymox Reports Update and Positive Safety Data for Phase 3 NX02-0022 Reinjection Study of NX-1207 for BPH
November 11 2013 - 11:45AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) reported a favorable
update and recent Safety Monitoring Committee review of safety data
for the Company's NX02-0022 reinjection study for NX-1207, Nymox's
investigational drug for benign prostatic hyperplasia (BPH). The
most recent Safety Monitoring Committee meeting found no
significant safety concerns to date. Enrollment in this study at
participating investigational sites across the U.S. has passed the
50% accrual level.
Trial NX02-0022 is an open label study of the safety and
efficacy of NX-1207 reinjection for the treatment of BPH. The study
is open to subjects who had previously participated in an NX-1207
BPH study. All patients are given an intraprostatic injection of
NX-1207 2.5 mg. The first of two NX-1207 reinjection studies
(NX02-0020) was successfully completed in January 2013. Patients
with BPH in the earlier NX02-0020 reinjection study received one or
two injections of NX-1207 into the prostate. Mean overall
improvement in the 192 treated men was 7.6 points in their AUA BPH
Symptom Scores (p < .001). The mean duration from the initial
injection to the final assessment was 26 months.
Ongoing testing of NX-1207 has not shown any evidence of the
drug eliciting an immune reaction in men treated with
intraprostatic injections of NX-1207. Extensive clinical
immunogenicity testing of men in the Company's pivotal Phase 3
trials (NX02-0017 and NX02-0018) and Phase 3 repeat injection
safety studies including the current Study NX02-0022 and the
earlier Study NX02-0020 have shown no evidence of antidrug antibody
formation. Safety monitoring reviews of the NX-1207 trials to date
have shown no evidence of any allergic reaction to the drug either
on first injection or repeat injection.
NX-1207 for the treatment of BPH is in Phase 3 development in
the U.S. In the EU a multi-center pivotal Phase 3 study is being
conducted under the sponsorship of the Company's European licensing
partner, Recordati S.p.A. Enrollment has been completed for the two
large U.S. pivotal Phase 3 studies (NX02-0017 and NX02-0018) and
the first U.S. reinjection study (NX02-0020) has been successfully
completed.
NX-1207 is also being evaluated in a U.S. Phase 2 study
(NX03-0040) for the treatment of localized low-risk prostate
cancer.This study is nearing completion.
NX-1207 is injected by a urologist under ultrasound guidance
directly into the area of the prostate to be treated in an
in-clinic procedure that takes only a few minutes and does not
require catheterization, anesthesia or sedation. Studies to date
have shown that intraprostatic NX-1207 treatment is well-tolerated
by patients, does not impair sexual function, and has not shown any
drug-related significant side effects. Previous clinical trials
found that a single administration of NX-1207 2.5 mg produced on
average improvements in the standardized BPH symptom score (8-10
points at 90 days) that were approximately double that reported for
currently approved BPH drugs (3-5 points). Follow-up studies have
shown durable clinically significant benefit for up to 7 ½ years
after a single treatment.
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.
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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