Tuesday, July 21, 2009, 1:00pm IDT

BioCancell Reports Receipt of Final Approval for Phase I/IIa Pancreatic Cancer Clinical Trial

Jerusalem, Israel -- BioCancell Therapeutics, Inc. (TASE:BICL) today announced that it received final approval from the Israeli Ministry of Health to commence a Phase I/IIa clinical trial of its drug BC-819, treating patients with inoperable pancreatic cancer. The trial will take place in the framework of an IND application to the FDA which went effective in January 2009.

The clinical trial is expected to include 9-12 patients, and will take place in three Israeli medical centers (Sheba in Tel Hashomer, Hadassah in Jerusalem and Meir in Kfar Saba) and in two US medical centers, pending local regulatory approvals. The purpose of the trial is to check the safety and primary efficacy of BC-819 as a treatment for pancreatic cancer. Each patient participating in the trial will receive four treatments of BC-819, twice per week over the course of two weeks. The optimal dose will be ascertained over the course of the trial.

The trial will be partially funded by a grant from the Israel-US Binational Industrial Research and Development (BIRD) Fund to BioCancell and its American partner, the Virginia Biosciences Development Center, in the amount of $950,000. It follows pre-clinical studies that showed that when a group of hamsters was treated with BC-819 and compared to a control group, primary pancreatic tumor volume in the treated group was significantly reduced (50%) as compared with those in the control group, and that tumor growth progression (TGP) was significantly reduced in the treated group as compared with the control group. In addition, it was shown that just one third of the treated group showed metastases, compared to 100% of the control group.  

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BioCancell's Technology - Patient-Oriented, Targeted Therapy

BioCancell's technology is both Personal and Targeted. The approach is based on the identification of particular genes that are highly expressed only in tumors ("Target Genes"). The regulatory sequences of these Target Genes are used to drive the expression of a toxin gene exclusively within tumor cells, enabling targeted tumor-cell destruction, leaving normal cells intact. In effect, the plasmid acts as "smart bombs", activated only inside their targets thus destroying only the cancerous cells, while leaving healthy cells intact.

The patient's eligibility for the treatment is determined by analyzing the patient's tumor for the expression of the specific Target Genes. The diagnosis of the expression of the Target Genes are, therefore, a prerequisite for treatment and is made possible through the Company's proprietary diagnostic technology that enables detection of even a single malignant cell. Only those patients with high expression levels of the Target Genes in their tumor are eligible for treatment with high confidence of success.

The Company has designated two genes as Target Genes - H19 and IGF2.

H19 Gene

Discovered in human cancer by Professor Avraham Hochberg in humans, H19 is an oncofetal gene that encodes RNA (with no protein product) that is expressed at high levels in over 30 types of human cancer tissues, while existing at a nearly undetectable level in the surrounding normal tissues, thus making it an optimal weapon in the fight against cancer.

The gene is expressed abundantly in the human placenta and in several embryonic tissues, but is repressed post-natally and only re-expressed with the appearance of cancer, within cancer cells. Studies show that H19 fulfills an important role in the process of tumorigenesis, and it is thought that the gene enables tumor cells to survive and proliferate under stress conditions.

About BioCancell

BioCancell Therapeutics Inc. is a biopharmaceuticals corporation specializing in the development of Patient-Oriented, Targeted Therapy for the treatment of numerous types of cancer. The Company's proprietary technology constitutes a novel paradigm for the targeted destruction of cancer cells, with no effect on normal surrounding tissue and no observed side effects, allowing for long-term, safe treatment and prevention of cancer.

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 15 years.

Between 2006-2009, BioCancell has successfully completed rounds of funding, including an initial public offering, totalling $14 million. Its securities are traded on the Tel Aviv Stock Exchange, with the major stockholders being Clal Biotechnology Industries, a member of the IDB group of companies, and Prof. Hochberg.

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.