"First patient in" is the call from the Innsbruck firm, Innovacell Biotechnologie AG, as the first patient was recruited at the MHAT Plovdiv clinic in Bulgaria for the Phase IIb study of the advanced therapy medicinal product, urocell®. The clinical study will be conducted, beside Bulgaria, in the Czech Republic, Germany, Poland and Romania at more than 50 clinics.
"Altogether in this controlled clinical study, some 245 patients will participate. The study objective is to determine the optimal dose for treatment and to evaluate the effectiveness in the indication of Stress Urinary Incontinence," explained Innovacell CEO, Ekkehart Steinhuber. Initial evidential results are expected for the fourth quarter of 2010. Innovacell is investing 10 million Euro in the Phase IIb study.
Innovative therapy
urocell® is based on an innovative therapy concept for the treatment of bladder weakness, aimed at people with damaged sphincters. In contrast to earlier types of therapy, that rely either on "bulking" methods or on surgical "lifting" of the urogenital tract, 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.
Phase IIb study
Immediately after completion of the Phase IIb study, Innovacell will start with the Phase III study. Said Steinhuber: "Its findings will 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."
Since 2007, the European Union has laid down a set procedure for the clinical development of tissue engineered products - it covers the preclinical stage up to the Phase III study, after which permission to market can be granted. After 30 December 2012 - the end of the transition period for the use of products which were on the market before a set date - no further marketing will be allowed without this centralized EU permission.
"Altogether in this controlled clinical study, some 245 patients will participate. The study objective is to determine the optimal dose for treatment and to evaluate the effectiveness in the indication of Stress Urinary Incontinence," explained Innovacell CEO, Ekkehart Steinhuber. Initial evidential results are expected for the fourth quarter of 2010. Innovacell is investing 10 million Euro in the Phase IIb study.
Innovative therapy
urocell® is based on an innovative therapy concept for the treatment of bladder weakness, aimed at people with damaged sphincters. In contrast to earlier types of therapy, that rely either on "bulking" methods or on surgical "lifting" of the urogenital tract, 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.
Phase IIb study
Immediately after completion of the Phase IIb study, Innovacell will start with the Phase III study. Said Steinhuber: "Its findings will 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."
Since 2007, the European Union has laid down a set procedure for the clinical development of tissue engineered products - it covers the preclinical stage up to the Phase III study, after which permission to market can be granted. After 30 December 2012 - the end of the transition period for the use of products which were on the market before a set date - no further marketing will be allowed without this centralized EU permission.
