International Stem Cell Corporation Announces Significant Progress Towards Clinical Development
CARLSBAD, CA--(Marketwire - Nov 29, 2012) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) ("ISCO" or "the Company"), a California-based biotechnology company focused on the development of therapeutic products, today announced the achievement of a critical milestone towards the clinical development of its stem cell therapy.
The Company's research and development team has created the world's first human clinical-grade stem cell lines with the ability to immune-match millions of individuals. ISCO's existing research-grade parthenogenetic stem cell lines, one of which contains the most common immune type in the Caucasian population and may be an immune-match to approximately 70 million people, are used in pre-clinical development. These new clinical-grade stem cell lines position ISCO to be able to conduct clinical trials in the United States.
Dr. Semechkin, CEO and Co-Chairman of the Board, comments, "We've been working diligently for three years to perfect this technology, which was first developed by our scientific founder, Dr. Elena Revazova in Moscow, and I'm excited to report that we have been able to derive new stem cell lines in the United States under the US and California regulatory frameworks. I'm optimistic that the new parthenogenetic stem cell lines, by providing a potentially unlimited supply of cells and tissue for transplantation, will be of great benefit to the medical community and patients world-wide."
The new stem cell lines, created using ISCO's proprietary technology, are the first of a new generation of clinical-grade human parthenogenetic stem cell (hpSC) lines created in the United States under US regulatory oversight and designed to meet FDA regulations. The US Food and Drug Administration developed Good Tissue Practice (GTP) and Good Manufacturing Practice (GMP) standards to ensure the safety of products developed for clinical use. Conforming to GMP is extremely important as it means that the cells can be used in clinical development programs.
The new lines have been confirmed by independent third-party testing to be "homozygous" in the HLA coding regions meaning that they have a simple genetic profile in the critical areas of the DNA that code for immune rejection. This feature is one of the most important differences of hpSC when compared with embryonic stem cells and a distinct clinical advantage because of their ability to be immune-matched to the patient. We expect the new lines to immune-match millions of individuals, and will be added to ISCO's existing bank providing a platform from which to develop cells and tissue for clinical use.
"The importance of this breakthrough cannot be overstated," commented Dr. Craw, Executive Vice President of ISCO. "Expanding our collection is not only important for our therapeutic programs, but also further establishes our leadership position in human stem cell technology. Achieving this critical milestone moves us along the path to make the transition into a clinical stage company."
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
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Safe harbor statement
Statements pertaining to anticipated developments, the potential uses of our technologies (including our human clinical grade stem cell lines) and other opportunities for the company and its subsidiaries, 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" or "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 and the management of collaborations, 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 forward-looking statements.
