News

Wednesday August 8, 2007, 10:45 am IDT Press Release

BioCancell reports completion of first part of clinical trial

Success to lead to an FDA/MoH request to approve Phase IIb clinical trial

Jerusalem, Israel -- BioCancell Therapeutics, Inc. announced today that the obligatory part of the Phase I/IIa clinical trial it is funding in superficial bladder cancer has been completed. The objectives of the trial taking place in two Israeli medical centers and including 18 patients, are to evaluate the safety, optimal dose and primary efficacy of BC-819 in patients suffering from superficial bladder cancer after failure of standard existing treatments.

Avi Barak, CEO of BioCancell, said, "We are pleased and proud that our activities continue with no surprises along the path that we had mapped out since the successful fundraising on the TASE. At the same time, we are continuing to prepare intensively for the beginning of Phase IIb following the successful conclusion we are reporting today. We already have the financial means needed to complete Phase IIb of the clinical trial in bladder cancer.”

According to Barak, “The trial is made up of two parts, in the first of which each patient received six weekly treatments. In the second, patients responding well to the treatment are offered up to nine additional monthly maintenance treatments.

"We expect to receive the summary report of the obligatory part of Phase I/IIa by mid-September, 2007. Based on the results collected thus far we expect the report  to confirm success in achieving the objectives set for this phase, while enabling progression to a Phase IIb clinical trial in patients suffering from superficial bladder cancer after failure of standard existing treatments.  

"We intend to begin Phase IIb in the fourth quarter of 2007. The aim of the phase will be testing the efficacy and safety of the drug at a dose of 20mg (the maximum dose given in the current phase, with no serious adverse effects related to the drug). The treatment of 33 patients will take place in approximately 6 medical centers in Israel and one in the U.S., pursuant to an IND approval from the FDA.”

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About BioCancell Therapeutics

BioCancell Therapeutics Inc. is a biotechnology company specializing in the development of Patient-Oriented, Targeted Therapy for the treatment of a wide range of cancers. It is a plasmid-based therapy using the promoter of a cancer-specific expressed gene coupled with a toxin. As an efficacious, highly selective treatment that has shown no side effects - it has the potential to be the magic bullet for which the medical industry is searching.

In 2006, BioCancell completed a private round of funding and IPO, totaling $8.5 million.

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.