Nymox Concludes Two Year Follow-Up Study of Hyperplasia Drug
Posted on: Thursday, 15 November 2007, 15:00 CST
Nymox Pharmaceutical has completed a follow-up study of NX-1207 for benign prostatic hyperplasia. The study evaluated symptomatic progress of over 100 subjects involved in the company's Phase II US clinical trial initiated in 2005.
Individuals in the study were assessed two years after NX-1207 treatment for symptomatic improvement, treatment outcomes, and durability of efficacy. This is the largest cohort of patients treated with NX-1207 followed for as long as two years thus far. The company expects to report the results of the follow-up study in the next two weeks once final analysis of the data is completed.
NX-1207 has successfully completed three US trials and several smaller long term follow-up studies to date. The company's Phase II double-blind, placebo controlled, randomized study showed positive efficacy and safety results for NX-1207 after three months in patients with benign prostatic hyperplasia (BPH). Overall, patients treated with NX-1207 showed after three months a mean improvement of 9.35 points in AUA symptom score values, the standard scale used to evaluate BPH drugs and treatments.
This improvement compares favorably to the 3.5 to 5 points reported in published studies of currently approved drugs for BPH and reached statistical significance when compared to placebo. Subjects treated with NX-1207 also showed an overall significant reduction in mean prostate volume.
The company says results of the trial demonstrated the excellent safety and side effect profile of NX-1207. Subjects treated with NX-1207 had no serious side effects. In particular, patients given NX-1207 had no significant sexual side effects.
Source: Datamonitor
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