Two injectable BPH drugs reach clinical trial milestones

Two injectable drugs for the treatment of BPH are approaching critical milestones: one, a phase II trial of the investigational drug NX-1207; the other, enrollment in the first of three multicenter phase III trials of cetrorelix.

Nymox Pharmaceutical Corp. has announced that its latest multicenter U.S. phase II study of the proprietary drug NX-1207 for the treatment of BPH is nearing completion. Data for two multicenter, phase II, prospective trials indicate the aggregated mean improvement in the primary endpoint of BPH symptom score in men who received a single intraprostatic injection of NX-1207, 2.5 mg, was 10.3 points, or a 44% improvement in symptom scores without serious side effects from the treatment, including no significant sexual side effects.

Previous blinded clinical trials have shown statistically significant improvement of BPH symptoms 3 months after a single treatment, and results of available subjects from the five previous studies have provided evidence of durable benefits from treatment for up to 3½ years follow-up, according to the company.

NX-1207 treatment is administered by intraprostatic injection of a single dose by a urologist in an office setting. The procedure lasts 5 to 10 minutes and does not require anesthesia or catheterization.

In related news, Æterna Zentaris has completed patient recruitment for the first efficacy trial of its phase III program of the investigational drug cetrorelix. The study involves approximately 600 patients primarily in the United States and Canada, with additional sites in Europe.

This first efficacy study will assess an intermittent dosage regimen of cetrorelix as a safe and tolerable treatment providing prolonged improvement in BPH-related signs and symptoms. After a 4-week no-treatment observation period to confirm severity and stability of voiding symptoms, the men will be randomly allocated to cetrorelix or placebo administered by intramuscular injections at weeks 0, 2, 26, and 28 and followed to week 52. Then, in an open-label extension, patients will receive cetrorelix by intramuscular injection at weeks 52, 54, 78, and 80, and will be followed to week 90.

The primary endpoint is absolute change in International Prostate Symptom Score between baseline and week 52.

Two additional phase III studies of the drug will follow.