September 23, 2014 – Jerusalem, Israel — BioCancell Ltd. (TASE:BICL) announced today the results of a bladder cancer clinical trial of BC-819, BioCancell’s first to include high-risk patients, and the first to combine BC-819 with BCG (a standard treatment for high-risk bladder cancer patients).
The trial comprised 17 patients who were treated using one of three treatment regimes following the surgical removal from the bladder of existing cancerous growths. No severe adverse events (SAEs) related to the drug were reported during the trial.
Results showed that 11 of the 17 participants (65%) had no disease recurrence over the 3 months from the start of treatment.
This trial is a pre-requisite for BioCancell’s clinical development plan, leading to a Phase III clinical trial of bladder cancer patients who have failed treatment with BCG.
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.