Date: 2011-09-05
Type of information:
phase: 2b
Announcement: conclusion of the phase
Company: Innovacell (Austria)
Product: ICES13
Action mechanism: autologous, individualized cell therapy
Disease: stress urinary incontinence
Therapeutic area:
Country: 4 undisclosed European states
Trial details:
Latest news: Innovacell has announced that the Phase IIb study of its cell therapy for the treatment of stress urinary incontinence ICES13, concludes successfully. This multi-centre Phase IIb study was conducted in 32 clinics in four European states. It embraced some 280 patients. This means the Phase III study can begin before the end of 2011 with the first results becoming available in the third quarter of 2012. Innovacel already has the necessary permission from the health authorities of two states to carry out the study. Approval from the European Medicines Agency (EMA) is expected to be forthcoming in 2013.