Sunday, December 14, 2008, 10:20am IST

BioCancell Submits IND Applications to FDA for
Ovarian and Pancreatic Cancer Phase I/IIa Trials

Jerusalem, Israel -- BioCancell Therapeutics, Inc. (TASE:BICL) announced that it had submitted Investigational New Drug (IND) applications to the US Food and Drug Authority (FDA) to commence Phase I/IIa clinical trials in patients suffering from ovarian and pancreatic cancer, with the primary purpose of measuring the safety and primary efficiency of the BC-819 drug in a series of dose escalations.

For pancreatic cancer, BC-819 will be administered intratumorally to 6-9 patients in four medical centers in Israel and the USA. Each patient will receive a total of four treatments over the course of two weeks. The trial will be partially funded by a BIRD grant in the amount of $950,000 to be received by BioCancell and its US partner, the Virginia Biosciences Development Center. The trial 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.

For ovarian cancer, BC-819 will be administered intraperitoneally to 12 patients in medical centers in Israel and the USA. Each patient will receive nine weekly treatments. Those responding to the treatment will be offered an additional six monthly maintenance treatments. The trial follows a compassionate use trial with a patient suffering from ovarian cancer characterized by intra-peritoneal distribution of metastases and ascites (liquid containing cancerous cells that builds up in the peritoneum as a result of the cancer), after the failure of conventional chemotherapy treatment. The results of the trial show that the drug caused no serious adverse events (SAE's) at any dosage, and that a decrease of 50% in the ovarian cancer marker protein CA-125 in the patient's blood was measured, as well as a significant decrease in the number of cancerous cells in the ascites, and reports by the patient and her doctors of a clinical improvement in her condition. Today, 13 months after the trial commenced, the patient's condition continues to be stable, with no new growths. Her quality of life increased during the course of the treatment.

In accordance with FDA regulations, the applications will go into effect and the clinical trials will begin if no notification to the contrary is received within 30 days of submission.

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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 2006-2008, BioCancell has successfully completed private rounds of funding and an initial public offering totalling $12.5 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.