Thursday, July 21, 2011, 3:45pm IST

BioCancell Receives FDA Approval to Commence Phase IIb Panreatic Cancer Clinical Trial

Jerusalem, Israel -- Biopharmaceutics company BioCancell Therapeutics, Inc. (TASE:BICL), a cancer treatment research & development company, announced that it was notified on July 20, 2011, that it had received approval from the Food and Drug Administration (FDA) to commence a Phase IIb pancreatic cancer clinical trial in the U.S.A, using BioCancell's lead product, BC-819 in sequence with the FDA-approved drug Gemzar (Gemcitabine), in patients with locally advanced unresectable pancreatic cancer who have never received treatment.

The clinical trial is expected to include approximately 100 participants in 25 to 30 medical centers in locations including the U.S.A., Europe and Israel. One group, comprised of half of the participants, is to be treated with the combination of BC-819 and Gemzar (the current standard chemotherapy for pancreatic cancer), while a second group is to be treated with Gemzar alone. The primary endpoint of the trial is progression-free survival.

An interim analysis to assess the safety of the treatment is planned after the recruitment of the first 18 patients, in order to determine the dose of BC-819 for the remainder of the clinical trial.

In advance of the commencement of the clinical trial, BioCancell will be required to receive regulatory approvals, including from local government authorities and participating medical centers.

This clinical trial comes in addition to two clinical trials currently being run by BioCancell - a Phase IIb clinical trial of BC-819 as a treatment for superficial bladder cancer, and a Phase I/IIa clinical trial of BC-819 as a treatment for ovarian cancer. It follows a Phase I/IIa clinical trial of BC-819 as a treatment for pancreatic cancer, and a pre-clinical hamster study comparing BC-819 used in sequence with Gemzar, to Gemzar alone.

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About BioCancell

BioCancell is a biopharmaceuticals company that specializes in the development of Targeted Cancer Therapies for the treatment of numerous types of cancer. The Company's technology offers a safe and long-term treatment of cancer, with no adverse effects.

BioCancell was co-founded in 2004 by Professor Avraham Hochberg, Professor of Molecular Biology at the Hebrew University of Jerusalem, based on technology developed by him over the past 20 years.

The drug candidates developed by the Company are targeted and their goal is to selectively destroy the cancer cells without affecting healthy cells (‘Targeted Cancer Therapy'). The approach is based on the identification of target genes, such as H19, that are expressed only in cancerous tumors, and not in healthy cells, and on the use of those genes for the activation of a toxin inside the cancerous cells only, thus destroying them without harming healthy cells. BioCancell's leading drug candidate, BC-819, is now in a Phase IIb clinical trial for the treatment of bladder carcinoma, and in Phase I/IIa trials for the treatment of pancreatic and ovarian cancer.

For more information, please visit http://www.biocancell.com.

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.