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Recordati and Nymox Announce the Start of European Phase III Clinical Trial for NX-1207

Recordati (Borsa Italiana:REC.MI) and Nymox Pharmaceutical Corporation (Nasdaq: NYMX) announced today 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). 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.

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.

Posted-In: News FDA Global

 

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