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Sunday, December 26, 2010, 12:00pm IST

BioCancell Announces Success in Pre-Clinical Trial of New Therapy BC-821 on Glioblastoma

Jerusalem, Israel -- BioCancell Therapeutics, Inc. has successfully completed pre-clinical animal studies, using mice, that examined the use of BioCancell's new product candidate BC-821 as a treatment for glioblastoma (the most common and aggressive type of primary human brain tumor). The research, carried out by Dr. Doron Amit in the Hebrew University laboratory of Prof. Abraham Hochberg, BioCancell's founder and chief scientist, showed that BC-821 succeeded in significantly inhibiting brain tumor volume growth in animals by 60% compared to an untreated control group. BioCancell considers these animal testing results to be a positive indication of the efficacy potential of BC-821 as a treatment for glioblastoma.


The mechanism of action of BC-821 is based on a plasmid that synthesizes Diphtheria Toxin in cancerous cells, activated by the regulatory sequences of either or both of two target genes: the H19 gene and the IGF2 gene, both of which are expressed in cancerous cells only. The expression of either target gene is sufficient to activate the drug. BC-821's double activation method is designed to kill more cancerous cells in a greater number of patients more efficiently. An international patent application for this product was filed in 2008.


In light of the initial results, BC-821 will undergo additional pre-clinical testing as a treatment for additional applications. BioCancell will consider continued development of this product candidate for types of cancer with high levels of IGF2 expression, depending on the resources available to the company.

 

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BioCancell's Technology - Targeted Cancer Therapy

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.

 

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 is, 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.

  

About BioCancell

BioCancell Therapeutics Inc. is a biopharmaceuticals corporation specializing in the development of Targeted Cancer 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 20 years.

 

BioCancell's securities are traded on the Tel Aviv Stock Exchange (TASE:BICL), with the major stockholders being Clal Biotechnology Industries, a member of the IDB group of companies, and Professor 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, pancreatic cancer and ovarian 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 and other factors described in our public filings. BioCancell does not undertake any obligation to update forward-looking statements.