Nymox Announces Completion of Second Pivotal Phase 3 NX-1207 Trial for BPH
May 08 2014 - 9:30AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today that
the last enrolled patient has completed participation in the
Company's pivotal Phase 3 clinical trial, NX02-0018. The NX02-0018
trial is the second of two pivotal prospective double blind
placebo-controlled U.S. clinical trials being conducted to evaluate
NX-1207 2.5 mg for the treatment of benign prostatic hyperplasia
(BPH), a common affliction of older men. The first pivotal Phase 3
trial of NX-1207 for BPH, NX02-0017, has already completed patient
participation. Both trials will be unblinded once data verification
and auditing activities have been completed.
NX-1207 is a novel patented drug developed by Nymox for the
treatment of BPH and localized prostate cancer. The drug is
administered by a urologist in an office setting directly into the
zone of the prostate to be treated. The procedure takes only a few
minutes, does not require sedation, anesthesia or catheterization,
and involves little or no pain or discomfort.
NX-1207 had previously successfully completed a series of
blinded controlled multi-center U.S. clinical trials for BPH where
a single 2.5 mg dose of NX-1207 was found to produce at 90 days an
average improvement in standardized symptom score about double that
reported for currently approved BPH drugs without causing the
sexual or cardiovascular side effects associated with those drugs.
Follow-up studies showed 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 5 years or more.
The Company recently announced top line results of its two dose
(2.5 mg or 15 mg) blinded prospective controlled Phase 2 study of
NX-1207 for the treatment of localized low-risk prostate cancer,
NX03-0040. Results indicated an overall benefit in terms of reduced
cancer progression in patients treated with a single injection of
NX-1207 into the area of the prostate where cancer was found as
compared to active surveillance (no treatment) controls. Follow-up
analysis after up to 22 months found that for patients with
upgraded biopsies in the treated area, those treated with NX-1207
required 85% less radiation and surgery treatments compared to
controls. Consistent with earlier clinical trial experience with
NX-1207, there were no significant safety issues or side effects
associated with either the high dose (15 mg) or low dose (2.5 mg)
of the drug in this study.
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
Nymox Pharmaceutical (NASDAQ:NYMX)
Historical Stock Chart
From Apr 2024 to May 2024
Nymox Pharmaceutical (NASDAQ:NYMX)
Historical Stock Chart
From May 2023 to May 2024