Jun 23 2010
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to report positive new results from the 48-60 month follow-up study of patients treated with NX-1207 in Study NX02-0014. The initial study, completed in the U.S. in 2006, reached statistical significance in Intent-to-Treat Primary Efficacy outcomes at 90 days post-treatment with NX-1207 2.5 mg. The new study assessed American Urological Association BPH Symptom Index scores in blinded subjects without additional NX-1207 treatment after 48-60 months. There were no significant drug safety problems reported by any subjects in the study initially as well as in the 5 year follow-up.
Patients in the new study were followed and have remained blinded subsequent to their participation in Nymox's U.S. Study NX02-0014. The initial study was undertaken in 2005-2006 at 43 U.S. sites and enrolled 175 subjects. The new study includes results from all currently available patients. The new study found that over 37% of patients who received NX-1207 2.5 mg had required no surgical treatments and were on no medications for their BPH. These patients had a mean improvement at 48-60 months of 10.1 points in their symptom scores. In the control group only 2 subjects had not required any additional BPH treatments. The NX-1207 2.5 mg cohort's level of improvement from baseline reached statistical significance (p<.001). Additional data from this new long-term study will be released at a later date.
In the initial study's Intent-to-Treat cohort after 90 days, patients receiving the 2.5 mg dose of NX-1207 had a mean BPH Symptom Score improvement of 11.0 points, which was markedly better than the improvement shown by control groups (p<.01). 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 follow-up studies of available subjects from NX-1207 clinical trials have provided evidence of durable benefits from NX-1207 treatment in some patients for up to 6½ years from the date of treatment.
NX-1207 is a novel patented drug developed by Nymox which is currently in Phase 3 trials.
SOURCE Nymox Pharmaceutical Corporation