Jerusalem, Israel, November 5, 2015, BioCanCell Ltd. (TASE: BICL), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapies to treat cancer-related diseases, today announced that the U.S. Patent and Trademark Office has approved a patent for BioCanCell’s second-generation drug, BC-821. BC-821 contains the regulatory sequences of the H19 gene, as well as the regulatory sequences of the IGF2 gene, which are both highly expressed in cancerous cells. BioCanCell is planning to commence the first clinical trial of BC-821 as a cancer therapy in 2016.
Patents covering BC-821 have already been approved in key markets including: Japan, Europe, Russia, China, Australia and South Korea.
Jonathan Burgin, Chief Executive Officer of BioCanCell, stated, “We are very pleased to have received this key patent approval from the U.S. Patent and Trademark Office. It is critical that BioCanCell protects and extends the Company’s intellectual portfolio as we move our potentially life-changing treatment through the clinic.”
BC-821’s active sequencesare based on two core elements, a promoter and subsequent DTA-coding sequence. However, BC-821 extends the potential efficacy of BC-819 by harboring a dual DTA expression system, driven by two distinct core promoters: the H19 promoter and the IGF2-P4 promoter segment. The IGF2 protein is a member of the “insulin-like growth factor” family that is involved in cell proliferation and differentiation. Similar to H19, the IGF2-P4 promoter is functional during two stages in life: embryogenesis and tumor development. Increased expression of IGF2 is frequently seen in a variety of human tumors, including hepatocellular carcinoma, breast cancer, ovarian cancer and prostate cancer.
BC-821 harnesses the cancer-specific expression patterns of both H19 and IGF2 by using their regulatory elements as cancer-dependent switches for activation of Diphtheria Toxin A.
BC-821 has been shown to inhibit different cancer cells in tissue-culture experiments (in vitro) and to repress tumor growth in animal models (in vivo). In addition, promising preliminary data shows that BC-821 inhibits very aggressive types of cancers and their metastases when administered intravenously with the transfection reagent polyethylenimine (PEI).
BioCanCell is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapies to treat cancer-related diseases. Its most advanced product candidate, BC-819, is under development as a treatment for non-muscle-invasive bladder cancer (NMIBC). BC-819 will enter two Phase III confirmatory studies in the first half of 2016. BioCanCell is also developing a second generation drug, BC-821 for the systemic treatment of advanced malignant neoplasms. Preclinical studies of BC-821 have showed significant efficacy in different cancer animal models such as metastatic lung cancer and metastatic liver cancer. BioCanCell’s third product candidate, BC-830, is a “liquid biopsy,” which is intended to replace invasive and costly cystoscopies for the follow-up of NMIBC patients.
BioCanCell’s R&D activities build upon the research of Professor Abraham Hochberg of the Hebrew University of Jerusalem. Professor Hochberg isolated the human H19 gene and determined that the gene is oncofetal and expressed in over forty different forms of cancer. H19-based therapy combines a highly selective method of killing cancer cells with a strong safety profile. Each of BioCanCell’s product candidates relies on a proprietary H19 technology platform, with the potential to provide benefits that are competitive with existing cancer treatment methods.
This press release contains “forward-looking statements” that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of clinical trials, the anticipated effects of receiving Fast Track designation, the anticipated timeframe for conducting additional clinical trials and making regulatory submissions, and other strategic and business plans and objectives. These forward-looking statements are based on information BioCanCell has when those statements are made or its management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. These risks and uncertainties include, but are not limited to: the success of the approach to discover and develop prospective therapeutic products, which is new and may never lead to marketable products; a lack of history of commercial sales; a dependence on the success of BC-819, the development of which will require significant additional clinical testing before regulatory approval can be sought and commercial sales launched; a need to raise substantial additional funds to complete R&D activities; an ability to overcome scientific or technological difficulties that may be encountered and that may impede R&D activities; and an ability to obtain and maintain intellectual property protection for product candidates, including pursuant to licensed patents.
Kirin M. Smith
Chief Operating Officer
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