Sunday, August 15, 2010, 11:30am IDT

BioCancell Receives Orphan Drug Approval for BC-819 as Treatment for Pancreatic Cancer

Jerusalem, Israel -- BioCancell Therapeutics Inc. (TASE:BICL) today announced that the US Food and Drug Administration (FDA) has granted orphan drug status to BioCancell's lead drug-candidate, BC-819 (currently in clinical trial stages), for use in treating pancreatic cancer.

An "orphan drug" is a drug for a disease that affects a relatively small number of people in a population. In the USA, an orphan drug is defined as one that treats a disease affecting less than 200,000 people each year. In order to encourage the development of drugs for such diseases, benefits and incentives can be granted to the drug developers. The main standard benefit for orphan drugs in the USA is the right to market the drug exclusively for 7 years from the date it is approved. Additional benefits include tax benefits on R&D expenses, and waived FDA fees.

Uri Danon, CEO of BioCancell, said, "We are pleased to receive orphan drug status for BC-819 for the treatment of pancreatic cancer, strengthening the future commercial potential of this application to become BioCancell's main growth engine. This orphan drug approval is in addition to a similar approval of orphan drug status for BC-819 for use in treating ovarian cancer, and forms a vote of confidence in BioCancell's technological potential to lead the field of cancer treatments. We intend to complete the pancreatic cancer Phase I/IIa trial and release results within a number of weeks."

As previously reported, BioCancell has been conducting a Phase I/IIa clinical trial for this application since November 2009, pursuant to an Investigational New Drug Approval from the FDA. The trial is expected to include nine patients, who each receive four treatments, twice per week for two weeks. The University of Maryland Medical Center in Baltimore, and Hadassah, Sheba and Meir Medical Centers in Israel are participating in the trial. Treatments are partially funded by the US-Israel Binational Industrial Research and Development Foundation (BIRD), which approved a grant in the amount of $950,000, or 50% of the predicted expenses of this project.

In January 2010, BioCancell reported completion of the first of two dosage cohorts in the clinical trial, with no treatment-related serious adverse events reported. Following a review of the safety results to confirm that the safety target of the first cohort had been achieved, the clinical monitor of the Clinical Trial approved the commencement of a second dosage cohort, with patients receiving the maximum planned dose of eight milligrams.

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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.