Friday, April 30, 2010, 5:30pm IDT

FDA Approves Continuation of Phase IIb Bladder Clinical Trial Based on Interim Results

This approval follows the completion of treatment of the first treatment group (comprised of 18 patients) to be treated in the context of this trial, and the receipt of the interim results.

Phase IIb Clinical Trial Interim Results

The following is a summary of the interim results of the Phase IIb clinical trial. The two efficacy criteria that need to be met in order to determine a complete response in a patient, are non-recurrence and ablation of a single tumor left in each patient's bladder, solely for the purpose of the clinical trial. Of these, the Company believes that non-recurrence is the major problem facing refractory superficial bladder cancer, and that this criterion is therefore of greater importance in determining what to expect from the treatment in market conditions.

In total, six patients showed a complete response, of whom two were discounted from the final statistics - one that was excluded from the patient count because she discontinued treatment before it was completed, and one that was included in the patient count, but was not listed as a complete response on account of a change in the criteria during the course of the trial. The FDA had required five patients to show a complete response, and, when presented with the complete interim results, approved the continuation of the trial.

As of the date hereof, no Serious Adverse Events (SAEs) related to the drug candidate have been recorded in this, or any other, clinical trial of BC-819.

Information Regarding the Clinical Trial

The purpose of this trial is to measure the efficacy and safety of BC-819 at a dose of 20mg, as tested in the previous Phase I/IIa clinical trial for this application. The trial is being conducted in a U.S.-based medical center in Arizona by BCG Oncology, PC and at seven medical centers in Israel. The trial is expected to include 33 patients, with each participant receiving six weekly treatments of BC-819. Patients responding to the treatment are offered nine additional maintenance treatments.

#############################################################

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.