Nymox Pharmaceutical Corporation announced that the company is nearing completion of a new multi-center US long-term followup study of NX-1207, its investigational drug for the treatment of benign prostatic hyperplasia (BPH).
The Company anticipates the reporting of final results and statistical analysis for the study within the next two weeks. The new study concerns assessment of the 30-36 month efficacy and benefits of a single treatment of NX-1207. Patients in the new study were followed and have remained blinded subsequent to their participation in Nymox’s US Study NX02-0016. The initial study was undertaken in 2007 at 32 US sites and enrolled 85 subjects. The new study includes results from all currently available patients.
In the initial study’s intent-to-treat cohort after 90 days, the tested therapeutic dose of NX-1207 had a mean BPH Symptom Score improvement of 9.71 points, which was markedly better than the improvement shown by control groups (p<.001). There were no significant side effects from NX-1207 in the trial.
In multicenter US 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 follow-up studies of available subjects from NX-1207 clinical trials have provided evidence of durable benefits from NX-1207 treatment for up to 6½ years from the date of treatment.
BPH or enlarged prostate is one of the most commonly diagnosed diseases in the male US population. The disorder affects approximately half of men over age 50 and close to 90 per cent 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.