Nymox provides update on NX-1207 Phase 3 program for benign prostatic hyperplasia

Jul 29 2010

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.