Nymox Reports Safety Monitoring Committee Findings for Pivotal Phase 3 NX-1207
Trials
HASBROUCK HEIGHTS, N.J., July 28, 2010 (GLOBE NEWSWIRE) -- Nymox
Pharmaceutical Corporation (Nasdaq:NYMX) provided an update today on the
Company's Phase 3 program for NX-1207, Nymox's investigational drug for benign
prostatic hyperplasia (BPH). The Safety Monitoring Committee meeting of July
22, 2010 for the Phase 3 U.S. pivotal trials of NX-1207 was favorable and
indicated no significant safety concerns for the trials to date. Patient
recruitment and trial activities for pivotal U.S. studies NX02-0017 and
NX02-0018 are proceeding at over 70 well-known urology investigative sites
throughout the U.S.
NX-1207 has been shown to improve the signs and symptoms of BPH, producing
improvements which reached statistical significance compared to double-blinded
placebo and study controls. A single administration of NX-1207 2.5 mg has
produced on average improvements in the standardized BPH symptom score (8-10
points) that were approximately double that reported for currently approved
BPH drugs (3-5 points). The drug is administered by a urologist in an office
setting and involves little or no pain or discomfort. NX-1207 has not been
found to have the sexual, blood pressure, or other side effects of the
approved drugs. Follow-up studies have shown clinical efficacy effects in men
lasting up to 5 years after a single treatment.
Recent positive data on NX-1207 was presented at a symposium and panel
discussion held at the Annual Meeting of the American Urological Association
in San Francisco in June. The well-attended symposium highlighted the ongoing
clinical development program for NX-1207 for the treatment of benign prostatic
hyperplasia (BPH) and featured expert panel discussions on the new therapy.
The symposium, "Progress with NX-1207: Phase 3 Pro-Apoptotic Injectable for
BPH," was chaired by Neal Shore, MD, FACS of Myrtle Beach, SC. Panel members
included Barrett Cowan, MD, FACS of Denver, CO, Barton Wachs, MD, FACS of Long
Beach, CA, and Chris Threatt, MD of Atherton, CA, and included a new research
report authored by Dr. Barrett Cowan, Dr. Kevin Cline of Shreveport, LA, Dr.
Sheldon Freedman of Las Vegas, NV, Dr. Pat Hezmall of Arlington, TX, Dr.
Barton Wachs, Dr. Chris Threatt, and Dr. Neal Shore. According to the report
"NX-1207 is an office-based procedure involving only a few minutes to
administer associated with minimal discomfort and no catheter requirement,"
and "results indicate statistically significant symptomatic improvement and a
very acceptable safety profile." According to Dr. Shore, a well known U.S.
clinical investigator and expert in prostate diseases, "If approved, NX-1207
will certainly change the landscape of how we treat BPH symptoms and would set
the standard for office-based therapy for BPH."
BPH is one of the most commonly diagnosed diseases in the male U.S.
population. The condition can seriously impact the health and quality of life
of older men 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.
