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In a new round of financing, shareholders of Innsbruck's Innovacell Biotechnologie AG agreed last Monday, September 27th, to make 4.3 million Euros worth of fresh capital available to the company. "Financing of the current Phase IIb multi-centre study for urocell® is thus totally secured," explained CEO Ekkehart Steinhuber.
The study, which is being carried out according to plan at more than 50 clinics in four EU countries, is a pre-requisite to get Marketing approval within the European Union.
"The study will be completed by the end of 2010 and we expect the results in the first quarter of 2011," Steinhuber announced. So far more than half of the 245 patients planed to be included in the clinical trial are already recruited. Altogether, Innovacell is investing some 10 million Euros for the clinical development.
Phase III study
Immediately after completing Phase IIb, Innovacell will commence the Phase III study. According to Steinhuber: "It's possible the study could still be concluded within 2011. With the results obtained from that, we would be able to seek EU-approval for our treatment from the responsible authority, the EMA in London.
Highly promising results
Steinhuber is also expecting positive results from a study being conducted at the moment in the University Clinic of Ljubljana, Slovenia. "The results obtained so far have been highly promising and I expect the final results from Slovenia during the fourth quarter of 2010."
Innovative therapy
urocell® is based on an innovative therapy concept for the treatment of urinary incontinence, which is suitable for patients with damaged sphincter muscles. In contrast to earlier therapies that rely on so-called "bulking" methods or surgical "lifting" of the uro-genital tract, urocell® is based on the principle that the body is able to regenerate the sphincter muscle using its own muscle cells.
The study, which is being carried out according to plan at more than 50 clinics in four EU countries, is a pre-requisite to get Marketing approval within the European Union.
"The study will be completed by the end of 2010 and we expect the results in the first quarter of 2011," Steinhuber announced. So far more than half of the 245 patients planed to be included in the clinical trial are already recruited. Altogether, Innovacell is investing some 10 million Euros for the clinical development.
Phase III study
Immediately after completing Phase IIb, Innovacell will commence the Phase III study. According to Steinhuber: "It's possible the study could still be concluded within 2011. With the results obtained from that, we would be able to seek EU-approval for our treatment from the responsible authority, the EMA in London.
Highly promising results
Steinhuber is also expecting positive results from a study being conducted at the moment in the University Clinic of Ljubljana, Slovenia. "The results obtained so far have been highly promising and I expect the final results from Slovenia during the fourth quarter of 2010."
Innovative therapy
urocell® is based on an innovative therapy concept for the treatment of urinary incontinence, which is suitable for patients with damaged sphincter muscles. In contrast to earlier therapies that rely on so-called "bulking" methods or surgical "lifting" of the uro-genital tract, urocell® is based on the principle that the body is able to regenerate the sphincter muscle using its own muscle cells.
