Nymox Reports Positive Results Of Safety Monitoring Review Of NX02-0018 Trial

(RTTNews) - Nymox Pharmaceutical Corp. (NYMX) reported favorable results from the most recent Safety Monitoring Committee periodic review of safety data for the Company's NX02-0018 clinical trial, one of the two Phase 3 pivotal trials for NX-1207, the company's investigational drug for benign prostatic hyperplasia or BPH.

The company said that Tuesday Safety Monitoring Committee meeting found no significant safety concerns to date. Both of the company's pivotal Phase 3 trials have completed enrollment and treatment (a single intraprostatic injection of either drug or placebo) and patient evaluation is continuing at over 70 well-known urology investigative sites across the U.S.

NX-1207 for the treatment of BPH is in Phase 3 development in the U.S. and in the EU under the sponsor of the Company's European licensing partner, Recordati S.p.A.

According to the company, NX-1207 is a first-in-class therapeutic that is administered directly into the prostate by a urologist in an office setting. The procedure does not require anaesthesia, sedation, or catheterization, takes only a few minutes and involves minimal discomfort to the patient. NX-1207 has thus far shown none of the adverse sexual side effects associated with approved medical and surgical treatments for BPH.

The company stated that previous clinical trials found that a single administration of NX-1207 2.5 mg 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) without the sexual, blood pressure, or other side effects associated with the approved drugs. Follow-up studies have shown durable clinically significant benefit for up to 7 1/2 years after a single treatment.

BPH is one of the most commonly diagnosed diseases in older men. The condition can have a significant negative impact on a man's health and quality of life and can lead to acute urinary retention, incontinence and other serious consequences.