Sunday, March 9, 2008, 10:25am IST Press Release

BioCancell Submits pre-IND Application to FDA for

Ovarian, Pancreatic and Liver Cancer Clinical Trials

Jerusalem, Israel -- BioCancell Therapeutics, Inc. (TASE:BICL) today announced that it has submitted a pre-IND package to the FDA regarding possible future Phase I clinical trials for treatment of pancreatic cancer, ovarian cancer and primary and metastatic liver cancer.

The FDA is expected to set a time for a meeting with representatives of BioCancell for a discussion about the proposed clinical trials. The purpose of the trials will be to check the safety and efficiency of BioCancell's leading drug, BC-819, in a series of dose escalations. If possible, the trials will take place in a number of medical centers in Israel and the USA.

BC-819 has been successfully tested in a Phase I/IIa bladder cancer clinical trial, and in individual compassionate use patients suffering from ovarian cancer and metastatic liver cancer. The drug is likewise being checked in an advanced Phase IIb bladder cancer clinical trial that recently began, following FDA approval.

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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 (Target Genes) that are highly expressed only in tumors. 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 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.

BC-819

BC-819 is BioCancell's leading product. It is a plasmid in which H19 regulatory sequences drive the expression of Diphtheria Toxin A gene. Besides the treatment of bladder cancer, BC-819 is in the process of being evaluated as treatment for liver, pancreatic and ovarian cancer and has shown efficacy in pre-clinical studies as well as in compassionate use. 

Pancreatic Cancer

A patient diagnosed with pancreatic cancer today has a 10-15% chance of surviving one year, which is the lowest survival rate of any common cancer type. A quarter of a million patients are diagnosed with this disease each year, and while it is the eleventh-most common cancer, it is the fourth-largest killer.

Some $2.6 billion is spent in the U.S. on treating pancreatic cancer annually.

Ovarian Cancer

Ovarian cancer attacks over 200,000 women each year, and is considered highly fatal. The current standard of treatment is surgery followed by chemotherapy. Despite the aggressive treatment approach, the level of recurrence is especially high in ovarian cancer, with the growth characterized by resistance to chemotherapy, causing patient mortality in over 65% of cases. According to the US National Cancer Institute, the cost of treatment in the US alone tops $2.2 billion annually. 

BioCancell Therapeutics

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.

In 2006, BioCancell successfully completed a private round of funding and an initial public offering totaling $8.5 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.