October 29, 2014 – Jerusalem, Israel — BioCancell Ltd. (TASE:BICL) is pleased to announce that, following discussions held over recent months with the FDA, it has received approval for the outline of its two Phase III clinical trials, the success of which will enable it to apply for a marketing approval for its lead drug, BC-819, in the United States.
BioCancell has received approval for two Phase III outlines in patients suffering from bladder cancer – one for patients who failed initial treatment with BCG, the conventional medication for treating bladder cancer (BCG Failures), and the second for patients resistant to treatment of BCG (BCG Refractory).
The BCG Failure trial will include two treatment arms – a group receiving a combination of BC-819 and BCG, and an additional group receiving BCG alone. Each group is expected to include about 235 patients. The goal of the trial is to prove that the combined administration is preferable to giving BCG alone. This trial will be performed using a Special Protocol Assessment, meaning that the Company has prior approval from the FDA that if the trial achieves its goals, BioCancell may receive marketing approval for the drug for this indication.
The BCG Refractory trial will include only one treatment arm (without a control group), with about 120 patients receiving BC-819. Trials of this kind do not receive SPA approval. The FDA recommended that trial be performed according to the outline that BioCancell had proposed. Similarly, BioCancell and the FDA agreed that there will be ongoing contacts during the trial, in order to maximize the possibility of bringing this drug to market.
BioCancell is performing additional operations in order to enable the commencement of the clinical trials towards to the end of 2015. To this end:
The Israeli Ministry of Health has approved the expansion of the BioCancell’s clinical trial providing a combination of BC-819 and BCG to high-risk bladder cancer patients. The trial will be expanded by 20 additional patients, split into two treatment regimens, in order to determine the optimal treatment regimen. This trial is expected to be completed during the first half of 2015.
An agreement was signed with German drug manufacturer BI to manufacture and supply BC-819 for the clinical trials phase, and beyond.
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.