BC-819: Additional Phase IIb data

Data from the second treatment cohort in an open-label, U.S. and Israeli Phase IIb trial in 39 patients with SBC that had failed prior treatment showed that 6 weekly intravesical instillations of 20 mg BC-819 met the primary endpoint of >=9 of 21 patients with a lack of disease recurrence at 3 months after starting treatment. BioCancell did not disclose how many patients in the second treatment cohort showed no disease recurrence at 3 months, but said that 25 of all 39 patients in both treatment cohorts achieved the endpoint. Additionally, 14 of 31 patients evaluated at 12 months after starting treatment and 10 of 25 patients evaluated at 24 months after starting treatment showed no disease recurrence. The mean recurrence-free period was 12.1 months. There was 1 severe adverse event of hematuria that may have been related to treatment with BC-819. BioCancell reported interim data from 18 patients in 2010 (see BioCentury, May 17, 2010). ...