Nymox Pharmaceutical Corporation provided an update on the company’s Phase 3 pivotal trials for NX-1207, Nymox’s investigational drug for benign prostatic hyperplasia (BPH). BPH can lead to acute urinary retention, incontinence, and other serious consequences.
The Safety Monitoring Committee meeting of August 16, 2011 was favorable and indicated no significant safety concerns for the two pivotal U.S. trials to date. Patient recruitment and trial activities for pivotal U.S. studies NX02-0017 and NX02-0018 are proceeding well 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 at 90 days) 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 many men lasting up to 7 1/2 years after a single treatment.
A symposium at the Annual Meeting of the American Urological Association May 17, 2011, “Clinical Studies of NX-1207: A Phase 3 Injectable for BPH,” was chaired by Neal Shore, MD, FACS of Myrtle Beach, SC. Panel members included Ronald F. Tutrone Jr., MD, FACS of Towson, MD, Barrett Cowan, MD, FACS of Denver, CO, and Barton Wachs, MD, FACS of Long Beach, CA. and included a new research report authored by Dr. Barrett Cowan, Dr. Sheldon Freedman of Las Vegas, NV, Dr. Barton Wachs, 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”.
Date: August 17, 2011
Source: Nymox Pharmaceutical Corporation
Filed Under: Drug Discovery
