Wednesday, October 5, 2011, 9:30am IST

BioCancell Receives Pancreatic Cancer "Fast Track" Designation; Commences Phase IIb Clinical Trial

Jerusalem, Israel -- Biopharmaceutics company BioCancell Therapeutics, Inc. (TASE:BICL), a cancer treatment research & development company, announced that it had received "Fast Track" designation from the FDA for its lead product, BC-819, as a treatment for locally-advanced pancreatic carcinoma. The Fast Track designation refers to a process designed to facilitate development and expedite FDA review of drugs to treat serious diseases and fill an unmet medical need in order to be able to offer such drugs to patients earlier. This designation is expected to help BioCancell shorten the development timeline for BC-819 as a treatment for pancreatic cancer prior to final marketing approval by reducing the time taken to process clinical trial results by the FDA.

In addition, on October 4, 2011, BioCancell's Phase IIb pancreatic cancer clinical trial commenced with the first treatment of the first patient at Meir Medical Center in Israel. The trial will examine the effect of BC-819 in sequence with the FDA-approved drug 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., Europe and Israel. Half of the participants will be treated with the combination of BC-819 and Gemcitabine (the current standard chemotherapy for pancreatic cancer), while the second half will be treated with Gemcitabine 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 appropriate dose of BC-819 to utilize for the remainder of the clinical trial.

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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 Phase IIb clinical trials for the treatment of bladder and pancreatic cancer, and a Phase I/IIa trial for the treatment of 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 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.