Nymox Reports Positive New Safety Study Data for Phase 3 BPH Drug
June 11 2014 - 9:15AM
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to
announce new clinical data supporting the positive safety profile
of NX-1207, the Company's lead compound in late Phase 3 testing for
prostate enlargement (BPH or benign prostate hyperplasia). Recent
pharmacokinetic studies using a newly developed highly sensitive
blood test for NX-1207 have shown that the drug is undetectable in
the blood post-injection, providing strong evidence that the drug,
once injected into the prostate, remains confined to the prostate
and thus unable to affect other organs such as the liver, kidneys,
heart, or testes. These results are consistent with the
pharmacological profile of the drug and with the extensive body of
safety data from the more than 1,000 men treated with the drug to
date demonstrating the absence of any significant drug-related side
effects.
In addition, men treated with NX-1207 have not displayed any
signs of an allergic or other immune reaction to the drug either on
first injection or repeat injection. 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 (NX02-0020 and NX02-0022) have found no evidence of
anti-drug antibody formation after exposure to the drug. The
Company will present more detailed scientific data from these
studies at upcoming medical conferences.
Currently approved drugs for BPH can produce significant sexual
side effects such as impotence, decreased libido, ejaculation
disorders, and male breast enlargement. In the clinical trials to
date, NX-1207 has not shown to produce these sexual effects. Some
approved BPH drugs, including combination drug therapies, are also
associated with an increased risk of high-grade prostate cancer. By
contrast, the area of the prostate targeted with NX-1207 treatment
showed less prostate cancer progression with less radiation and
surgery due to cancer progression as compared to controls in the
recent NX03-0040 Phase 2 localized prostate cancer trial.
Nymox recently announced the completion of its second pivotal
Phase 3 trial of NX-1207 for BPH, NX02-0018, and top-line results
for its Phase 2 trial of NX-1207 for localized low risk prostate
cancer, NX03-0040.
NX-1207 is a novel patented drug developed by Nymox that 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 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.
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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