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news.Innovacell Biotechnologie has enrolled first patient at the Mhat Plovdiv clinic in Bulgaria for the Phase IIb study of Urocell, an advanced therapy medicinal product. The clinical study is expected to be conducted, beside Bulgaria, in the Czech Republic, Germany, Poland and Romania at more than 50 clinics.
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Urocell is based on an innovative therapy concept for the treatment of bladder weakness, aimed at people with damaged sphincters. Urocell is based on the principle of the body’s own ability to regenerate the sphincter muscle by using the patient’s own muscle cells.
Ekkehart Steinhuber, CEO of Innovacell, said: “Altogether in this controlled clinical study, some 245 patients are expected to participate.
“The study objective is to determine the optimal dose for treatment and to evaluate the effectiveness in the indication of Stress Urinary Incontinence. Initial evidential results are expected for the fourth quarter of 2010. Innovacell is investing EUR10m in the Phase IIb study.”
Innovacell said that immediately after completion of the Phase IIb study, it is expected to start with the Phase III study.
Mr Steinhuber added: “Its findings are expected to be available in 2011. When the results are established, we will apply for an EU-marketing authorisation at the european medicines agency (EMEA) in London.”