Thursday,October 7, 2010, 12:45pm IST

BioCancell Completes Phase I/IIa Panreatic Cancer Clinical Trial

Jerusalem, Israel -- Biopharmaceutics company BioCancell Therapeutics, Inc. (TASE:BICL), a cancer treatment research & development company, announced that on October 6, 2010, treatment was completed of the second and last dosage cohort in Biocancell's Phase I/IIa clinical trial for use in treating pancreatic cancer. The primary purpose of the trial is to establish the safety (including optimal dose) and primary efficacy of BioCancell's lead drug-candidate, BC-819 as a treatment for pancreatic cancer. The results of the trial, which was concluded in less than a year, are undergoing statistical analysis, and are expected to be published when complete.

The trial included nine patients (three in the initial dosage cohort, and six more in the second), and took place in University of Maryland Medical Center in Baltimore, MD, and Hadassah, Sheba, Hillel Yafehand Meir Medical Centers in Israel. Participants received four treatments of the drug over the course of two weeks. Treatments were partially funded by the US-Israel Binational Industrial Research and Development Foundation (BIRD), which approved a grant in the amount of $950,000.

Biocancell also recently completed another important milestone on the road to marketing a drug for pancreatic cancer, when the FDA granted the treatment "orphan drug" status. This approval gives BioCancell exclusive marketing rights in the USA for a period of 7 years.

Cancer of the pancreas is one of the deadliest types of cancer, with 80% of patients expected to die within a year of diagnosis, and 95% within five years. BC-819, developed by BioCancell founder Prof. Abraham Hochberg of the Hebrew University of Jerusalem, Israel, uses the H19 gene to synthesize Diphtheria Toxin in cancerous cells only, in order to destroy them. Recent clinical trial results of the product, also undergoing Phase IIb testing for bladder cancer and Phase I/IIa testing for ovarian cancer, have clarified the efficacy of the mechanism of action of H19 against cancerous cells.

"Recent research results show that H19 is one of the most important genes in the development of human cancer," confirmed Prof. Hochberg. Results from his laboratory recently published in the prestigious Molecular Cell Research journal demonstrated a direct link between H19 and p53 (one of the most researched proteins in the field of cancer study). "As a result of the targeted destruction of cancer cells only, no severe side effects connected to the use of BC-819 have been observed." Prof. Hochberg added that his laboratory had published nine scientific papers in the last year, proving the mechanism of action of the drug.

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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.