NX 1207 (Recordati/Nymox) starts Phase III trial for BPH

Recordati and Nymox Pharmaceutical Corporation announced the start of activities aimed to the preparation of a European Phase III clinical trial for NX-1207, following the successful completion of a Scientific Advice meeting with the European Medicines Agency. NX-1207, is a Phase III investigational drug from Nymox and is currently in clinical development in the United States for the treatment of Benign Prostatic Hyperplasia (BPH). The pivotal controlled clinical trial will assess the efficacy and safety of a single TRUS-guided intraprostatic injection of NX-1207 in patients with lower urinary tract symptoms (LUTS) associated with BPH not adequately controlled by medical therapy.The drug is injected by a urologist in an office setting directly into the zone of the prostate where the enlargement occurs and involves little or no pain or discomfort. NX-1207 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 improve the signs and symptoms of BPH, with improvements about double those reported for currently approved BPH drugs, and without the side effects associated with those drugs, which can include sexual problems and blood pressure changes. Follow-up studies have shown evidence of long lasting benefit with a significant proportion of men reporting maintained improvement in BPH symptoms without other treatments for up to 7� years.