BioCancell gets FDA approval for Phase IIb Bladder Cancer clinical trial

BioCancell gets FDA approval for Phase IIb Bladder Cancer clinical trial

Approval follows the success of recently-concluded Phase I/IIa clinical trial

Jerusalem, Israel -- BioCancell Therapeutics, Inc. (TASE:BICL) today announced that it had received FDA approval to begin a Phase IIb clinical trial testing its leading drug, BC-819, for use in people suffering from superficial bladder cancer who had failed a standard conventional treatment.

The purpose of the trial is to measure the efficiency and safety of the BC-819 drug at a dose of 20mg, as successfully tested in the previous Phase I/IIa clinical trial. The trial is supposed to take place in the following medical centers: Assaf Harofeh in Tzrifin, Hillel Yafeh in Haderah, Meir in Kfar Saba, Rabin in Petach Tikvah, Sha’arei Tzedek in Jerusalem, Sheba in Ramat Gan, Wolfson in Holon, and BCG Oncology, PC in Arizona, USA. It will include 33 patients, divided into groups of 18 and 15. Each participant will receive six weekly treatments of BC-819. Patients responding to the treatment will be offered an additional nine monthly maintenance treatments. The trial is expected to commence in the coming weeks, and end in the last quarter of 2008.

For information about participation in the bladder cancer clinical trial in Israel, please contact Dr Patricia Ohana at 02-658-5457.


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.


Bladder Cancer

According to the American Cancer Society, urinary bladder cancer has the fourth highest incidence rate of all types, accounting for approximately 5% of all cancer cases. There are about 67,160 cases of superficial bladder cancer in the United States alone each year, with an annual mortality of 13,750 cases and prevalence of 600,000. Three quarters of patients are male, with 1 in 28 American men expected to develop bladder cancer in their lifetime. Some $1.9 billion is spent in the U.S. on treating bladder cancer annually.

Bladder cancer is a disease with a very high level of recurrence. Patients participating in the Phase I/IIa clinical trial sponsored by BioCancell, for example, had previously suffered from recurrence of bladder cancer an average of five times before enrolling.

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.

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.

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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.