Nymox Pharmaceutical Corporation announced that recruitment will begin for NX02-0020, a small open-label short-term safety study of NX-1207, the company’s Phase 3 drug for benign prostatic hyperplasia (BPH). The study will enroll approximately 100-200 subjects who have already participated in previous studies of NX-1207. The study will assess the safety of repeat injection of the drug. Previous studies of NX-1207 have been single injection only.
Eligible subjects will be enrolled from approximately 70 U.S. clinical trial sites.
The study will run concurrently with the large pivotal Phase 3 studies of NX-1207 which are ongoing. NX02-0020 is expected to be concluded before the pivotal studies NX02-0017 and NX02-0018 are completed. For each enrolled subject in the new trial, participation will last 90 days.
Dr. Paul Averback, CEO of Nymox, said, “The urologist clinical investigators are very pleased about the open-label NX-1207 now being available in Study NX02-0020 to their subjects who have completed the clinical trials. We are optimistic that the pivotal studies NX02-0017 and NX02-0018 will have full enrollment at a reasonable date. The 2 pivotal Phase 3 U.S. studies passed the 500 patient enrollment milestone several months ago.”
Dr. Averback added, “We continue to negotiate and have discussions with a number of large marketing partners who have interest in licensing NX-1207 for the U.S. and for Asia, and we are very optimistic with regard to the next marketing partnership deal.”
Nymox announced a licensing agreement for the development and commercialization of NX-1207 in Europe with Recordati on December 16, 2010. NX-1207 is a novel patented drug developed by Nymox which is currently in Phase 3 trials. The drug has successfully completed a series of blinded controlled multi-center U.S. clinical trials where a single dose of NX-1207 has been found to produce symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs. Follow-up studies have shown evidence of long lasting benefit with a significant proportion of men who received a single dose reporting maintained improvement in BPH symptoms without other treatments for up to 7 1/2 years. NX-1207 is injected by a urologist in an office setting and involves little or no pain or discomfort.
Date: May 10, 2011
Source: Nymox Pharmaceutical Corporation
Filed Under: Drug Discovery