Date: 2012-02-21
Type of information: Initiation of preclinical development
phase: 3
Announcement: initiation
Company: Recordati (Italy) Nymox Pharmaceutical (USA)
Product: NX-1207
Action mechanism:
Disease: benign prostatic hyperplasia
Therapeutic area: Urology
Country: Europe
Trial
details: 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.
Latest
news: Recordati and Nymox Pharmaceutical 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 (EMA). NX-1207, Nymox’s Phase III investigational drug, is currently in clinical development in the U.S. for the treatment of benign prostatic hyperplasia (BPH).
A European licensing agreement for the development and commercialization of NX-1207 was signed on 16 December 2010 by Recordati and Nymox Pharmaceutical Corporation. Under the terms of the agreement Recordati received exclusive rights to develop and subsequently market and sell NX-1207 in Europe including Russia and the CIS, the Middle East, South Africa and the Maghreb area of North Africa.
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 7½ years.
Two pivotal U.S. trials are currently ongoing at over 80 well-known urology investigative sites throughout the U.S. Accrual numbers have reached over 80%, and steady progress has been made toward full enrollment.
