Nymox Pharmaceutical Corporation has announced that the Company's latest multi-center U.S. study of NX-1207, its investigational drug for the treatment of benign prostatic hyperplasia (BPH), is nearing completion.
The Company anticipates the reporting of final results and statistical analysis for the study within the next 2-3 weeks. The new study concerns assessment of the one year efficacy effects of a single treatment of NX-1207.
NX-1207 has entered its Phase 3 development program, the last stage before filing with the FDA for approval. The drug involves a new targeted approach to the treatment of BPH. NX-1207 is injected by a urologist in an office setting directly into the zone of the prostate where the enlargement occurs. The entire procedure lasts on average 5-10 minutes, with the injection taking 1-2 minutes, does not require anesthesia or catheterization, and involves little or no pain or discomfort.
Reception to independent presentations of data from clinical trials of NX-1207 given at recent U.S. specialty urology (AUA) meetings has been very positive. In multicenter U.S. clinical trials to date NX-1207 has been found to produce improvements in BPH symptom score that are approximately double that reported for currently approved BPH drugs without the side effects associated with those drugs, which can include sexual dysfunction, blood pressure changes and other adverse reactions. Results of 6 follow-up studies of available subjects from NX-1207 clinical trials have provided evidence of durable benefits from NX-1207 treatment for up to 4½ years from the date of treatment.
BPH or enlarged prostate is one of the most commonly diagnosed diseases in the male U.S. population with a large portion of any primary care physician’s or urologist’s practice consisting of BPH management. The disorder affects approximately half of men over age 50 and close to 90% of men by age 80, and is associated with growth in prostate size as men age. BPH causes difficulties with urination associated with aging, such as urination at night, urge to void frequently, hesitancy, weak stream, and other problems. If left untreated, BPH can lead to significant consequences, such as acute urinary retention, incontinence, and urinary tract infection.