News

Wednesday December 5, 2007, 11:35 am IST Press Release

BioCancell reports successful experimental treatment using BC-819 for ovarian cancer

Patient and her doctors report clinical improvement in her condition

Jerusalem, Israel -- BioCancell Therapeutics, Inc. announced today the successful completion of an experimental treatment using BC-819 for the treatment of a compassionate 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.

In the framework of the experiment, the patient received six doses of BC-819, in doses ranging from 80mg to 120mg administered by intra-peritoneal infusions via catheter. This is the first time the drug has been administered by direct intra-peritoneal infusion, indicating an important breakthrough in cancer therapy.

The results of the experiment 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. 

The patient and her doctors report a clinical improvement in her condition.

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About Ovarian Cancer

Ovarian cancer attacks over 200,000 women each year, and is considered highly fatal. The current standard of treatment is surgery followed by chemotherapy. Despite the aggressive treatment approach, the level of recurrence is especially high in ovarian cancer, with the growth characterized by resistance to chemotherapy, causing patient mortality in over 65% of cases. According to the US National Cancer Institute, the cost of treatment in the US alone tops $2.2 billion annually. 

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.

BC-819

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. A Phase I/IIa clinical trial in refractory bladder cancer led to the conclusion that it has the ability to cause tumor ablation and regression at doses that are well tolerated, while preventing the appearance of new growths.

BioCancell Therapeutics

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.

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.