HASBROUCK HEIGHTS, N.J., March 19 /CNW/ - Nymox Pharmaceutical
Corporation (NASDAQ: NYMX) today announced positive results from its newly
completed long-term outcome study of NX-1207 for benign prostatic hyperplasia
(BPH). 26 clinical trial sites across the U.S. and 116 unselected subjects
participated in the blinded, placebo controlled study.
The study assessed symptom scores and treatment outcome 8-19 months after
NX-1207 treatment. Overall, without further NX-1207 treatment, patients
initially treated with NX-1207 showed a total pooled mean improvement of 7.4
points in the primary outcome endpoint of AUA Symptom Score values, which
reached statistical significance when compared with the placebo control
In terms of treatment outcomes, patients treated with NX-1207 had
statistically significantly more (p=.02) favorable outcomes compared to
There have been no significant sexual side effects from NX-1207.
Paul Averback MD, CEO of Nymox said, "Nymox is continuing to carefully
move this drug ahead as rapidly as possible. This placebo-controlled blinded
clinical study demonstrates a striking degree of long-term improvement in BPH
patients given NX-1207, and confirms the promising results from the earlier
completed U.S. clinical trials."
Dr. Averback added, "The durability of BPH symptom improvement from
NX-1207 treatment is clearly shown by this new data, which is of special
interest to potential marketing partners for NX-1207."
The Company previously completed three U.S. trials for NX-1207, including
most recently a Phase 2 double-blind, placebo controlled, randomized
multi-site U.S. study, which showed positive efficacy and safety results for
NX-1207 after 3 months in patients with BPH. Overall, patients treated with
NX-1207 showed after 3 months a mean improvement of 9.35 points in AUA Symptom
Score values, the standard scale used to evaluate BPH drugs and treatments.
This improvement compares favorably to the 3.5 to 5 point reported in
published studies of currently approved drugs for BPH and reached statistical
significance when compared to placebo. Subjects treated with NX-1207 also
showed an overall significant reduction in mean prostate volume. The results
of the trial demonstrated the excellent safety and side effect profile of
NX-1207. Subjects treated with NX-1207 had no serious side effects. In
particular, patients given NX-1207 had no (0%) significant sexual side
The AUA Symptom Score is a standardized measurement of BPH symptoms and
includes data on 1) sensations of incomplete emptying of the bladder; 2) need
to urinate frequently; 3) stopping and starting during urination; 4) urgent
need to urinate; 5) weakness of urinary stream; 6) need to push or strain
during urination; and 7) urination during sleep (nocturia). Published studies
of currently approved drugs for BPH show AUA Symptom Score improvement in the
3.5 to 5 point range.
BPH afflicts approximately half of men over age 50 and close to 90% of
men by age 80. The disorder causes difficulties with urination associated with
aging, such as urination at night, urge to void frequently, hesitancy, weak
stream, and other problems.
More information about Nymox is available at www.nymox.com, email:
email@example.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.
The conduct of clinical trials and the development of drug products involve
substantial risks and uncertainties and actual results may differ materially
from expectations. Promising early results do not ensure that later stage or
larger scale clinical trials will be successful or will proceed as expected.
Such factors are detailed from time to time in Nymox's filings with the United
States Securities and Exchange Commission and other regulatory authorities.
For further information:
For further information: Nymox Pharmaceutical Corporation Roy Wolvin,