Nymox updates NX-1207 Phase 3 pivotal trials for benign prostatic hyperplasia

Oct 28 2010

Nymox Pharmaceutical Corporation (Nasdaq:NYMX) provided an update today on the Company's Phase 3 pivotal trials for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The Safety Monitoring Committee meeting of October 25, 2010 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 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 men lasting up to 5 years after a single treatment.

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".

In a recently published peer-reviewed publication, "NX-1207: a novel investigational drug for the treatment of benign prostatic hyperplasia" in Expert Opinion on Investigational Drugs (2010 Feb;19(2):305-10), the author, Neal Shore MD FACS, Medical Director of the Carolina Urologic Research Center, Myrtle Beach, SC, wrote: "Regarding existing oral drug therapies, the use of NX-1207 would obviate daily and lifelong compliance issues as well as the ongoing concerns of polypharmacy facing the elderly and the attendant risk for drug–drug interactions. In comparison to office-based MIST options, the transrectal injection approach afforded by NX-1207, both anesthetic/analgesic free as well as catheter free, will be quite compelling to most patients. If the ongoing Phase III trials can duplicate the success seen in earlier trials, for both efficacy and safety, then the administration of NX-1207 should be expected to significantly impact the current pattern of treatment options employed by urologists for their patients with 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.