BioCanCell Announces Final Phase IIb Bladder Cancer Trial Results

March 17, 2013 – Jerusalem, Israel — BioCancell Ltd. (TASE:BICL) today announced final results in its Phase IIb bladder cancer clinical trial, designed to test the efficacy and safety of BC-819 with patients diagnosed with bladder cancer who had failed a standard treatment (BCG or chemotherapy). The trial included 39 patients who received six weekly, 20mg doses of BC-819, and some of whom received nine additional maintenance treatments over the course of nine months, as long as no disease recurrence was observed.

Among the results of the trial:

  • 25 of the 39 participants (64%) showed no disease recurrence over three months (Complete Response). BioCancell thus met its primary endpoint for efficacy in this trial.
  • 31 of the participants have completed 12 months from the start of treatment. 14 of them (45%) have shown no disease recurrence over this period.
  • 25 of the participants have completed 24 months from the start of treatment. 10 of them (40%) have shown no disease recurrence over this period.
  • The mean recurrence-free survival period was 12.1 months.
  • A large majority of participants (more than 80%) reported stable quality of life on the Karnofsky scale throughout the clinical trial, with no degradation of day-to-day performance typical of bladder cancer patients receiving existing therapies.
  • One patient alone had a severe adverse event that was possibly related to the mode of treatment (bladder instillation), which underscores the high safety profile of the drug.

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This press release contains “forward-looking” statements, including statements with respect to the further development and potential safety and efficacy of BC-819, in the treatment of superficial bladder cancer and BioCancell’s development strategy. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. There are a number of important factors that could cause the results of BioCancell to differ materially from those indicated by these forward-looking statements, including, among others, the risk that the U.S. Food and Drug Administration may require changes to the protocols and informed consents for clinical trials of BC-819, which changes may have a material adverse effect on the timing of, and BioCancell’s ability to conduct, those clinical trials, risks related to the clinical advancement of its BC-819 plasmid, including, but not limited, to the risk that clinical trials for this product candidate may not demonstrate safety and efficacy sufficient to obtain the requisite regulatory approvals or to result in a marketable product and risks related to the potential for others to develop products containing or based on BC-819. BioCancell does not undertake any obligation to update forward-looking statements.