OCEANSIDE, CA – February 4, 2010 – International Stem Cell Corporation (ISCO.OB), www.internationalstemcell.com, announced today that its new cell production facility has passed final building inspection, which will enable development and manufacturing of the company and its partners’ clinical-grade stem cell products.
ISCO has designed and built a unique cell manufacturing facility in Oceanside, California consisting of separate “suites” for development and production of different cell types from the company’s proprietary human parthenogenic stem cell (hpSC) technology. The facility is located in close proximity to the fertility clinics that provide donated human eggs (oocytes) under ISCO’s recently-established partnerships and also near leading Californian research institutions with whom ISCO collaborates on fundamental stem cell biology and therapeutic applications.
ISCO will implement its parthenogenic stem cell processes at this facility during 2010 and adopt current good manufacturing practice (cGMP) standards.In parallel, ISCO will collaborate with world-leading scientists to demonstrate the therapeutic applicability and the potential immune-rejection advantages of hpSC lines relative to other stem cell classes.
Like embryonic stem cells (ESCs), hpSCs are pluripotent (i.e. have the capacity to become almost any cell type in the body), yet avoid ethical issues associated with destruction or use of viable human embryos. Unlike induced pluripotent stem cells (iPSs), hpSCs do not require manipulation of gene expression back to a less differentiated stage, which may prove to be a safety or regulatory obstacle. However, unlike both ESCs and iPSs, hpSCs can be created in a homozygous form such that each line can be an immunological match for millions of patients.
Dr. Andrey Semechkin, ISCO’s CEO, says: “Our ability to work in this modern facility gives International Stem Cell Corporation the capacity to generate the world’s first cGMP quality hpSC lines. It marks an important milestone since it both expands the resources available to our scientists and expands ISCO’s ability to execute on its plan to become the premier provider of immune-matched stem cells to the global research community. Through these cells, ISCO will be able to treat a range of degenerative diseases in genetically diverse populations around the world.”
ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in the creation of parthenogenetic human stem cells from unfertilized eggs (oocytes). Like embryonic stem cells (ESCs), hpSCs are pluripotent (i.e. have the capacity to become almost any cell type in the body), yet avoid ethical issues associated with use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO’s website, www.internationalstemcell.com.
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Statements pertaining to anticipated future financial and/or operating results, future growth in research, technology, clinical development and potential joint venture and other opportunities for the company and its subsidiary, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update these forward-looking statements.
Key Words: Stem Cells, Biotechnology, Parthenogenesis
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
Brian Lundstrom, President