February 4, 2013 – Jerusalem, Israel — BioCancell Ltd. (TASE:BICL) today announced first-stage results in its Phase IIb pancreatic cancer clinical trial, designed to test the efficacy and safety of BC-819 with patients diagnosed with pancreatic cancer.
The drug was administered in two dosage levels to 11 patients, with five receiving an 8mg dose and six receiving 12 mg. Nine of the 11 participants showed progression-free survival for the three months of treatment, including all the patients in the high-dosage group and three of the five in the low dosage group.
An independent Data and Safety Monitoring Board reviewed these results and confirmed that no severe adverse event related to BC-819 had occurred, and that there was no difference in the safety profile of the treatment for the high-dosage group as compared to the low-dosage group. Any severe adverse events recorded were attributable to the disease itself, the use of the chemotherapeutic drug Gemcitabine, or the mode of administration of BC-819 into the pancreatic growth.
BioCancell will learn the first-stage results in-depth, and use this information to help plan continued drug development for this indication, including the possibility of further increasing the dosage given.
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.