|
Monday, May 4, 2009, 11:00am IDT BioCancell Reports Successful Treatment of Compassionate Use Patient with TCC in Renal Pelvis Jerusalem, Israel -- BioCancell Therapeutics, Inc. (TASE:BICL) today that a compassionate use trial of BC-819 was performed with a patient suffering from TCC (Transitional Cell Carcinoma) in his renal pelvis. The patient had previously undergone nephrectomy (kidney removal) of his right kidney for similar reasons, and was a candidate for nephrectomy of his left kidney, which would have forced him to undergo dialysis for the remainder of his life. After receiving the relevant approvals and performing tests that showed that the patient was a good candidate for BC-819, his doctors commenced treatment. The patient received a series of six treatments, 10mg each, injected into his renal pelvis. Test results show that no new growths were formed in the renal pelvis (a year after the patient was a candidate for nephrectomy), and the treatment did not cause any serious adverse effects. The patient reported that he continued to function and work with a similar quality of life as previously, and his doctors reported their desire to use BioCancell's drug in similar cases in the future. Prof. Avraham Hochberg, Chairman of the Board and Chief Scientist of BioCancell, said, "The results of the treatment show that BC-819 can be used as a means to preserve the kidneys and urinary bladders of patients who were previously candidates for removal of these organs from their bodies, and, as such, to prevent serious damage to their quality of life." BioCancell announced that it would consider continued development of its drug for this indication in the future, in accordance with the amount of resources available.
##################### 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. H19 Gene Discovered in human cancer by Professor Avraham Hochberg in humans, H19 is an oncofetal gene that encodes RNA (with no protein product) that is expressed at high levels in over 30 types of human cancer tissues, while existing at a nearly undetectable level in the surrounding normal tissues, thus making it an optimal weapon in the fight against cancer. The gene is expressed abundantly in the human placenta and in several embryonic tissues, but is repressed post-natally and only re-expressed with the appearance of cancer, within cancer cells. Studies show that H19 fulfills an important role in the process of tumorigenesis, and it is thought that the gene enables tumor cells to survive and proliferate under stress conditions. 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. Between 2006-2008, BioCancell has successfully completed private rounds of funding and an initial public offering totalling $12.5 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. |