SOURCE: International Stem Cell Corporation

International Stem Cell Corporation

May 30, 2013 08:30 ET

International Stem Cell Corporation Initiates IND-Enabling Study in Parkinson's Disease Program

CARLSBAD, CA--(Marketwired - May 30, 2013) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a California-based biotechnology company developing novel stem cell based therapies, announced today the initiation of its IND-enabling pharmacology and toxicology non-human primate studies, under the direction of Yale School of Medicine Professor D. Eugene Redmond Jr. MD, the internationally recognized neurosurgeon and a leader in the use of stem cells for the treatment of Parkinson's disease.

The studies will use non-human primates with moderate to severe Parkinson's disease symptoms to assess the safety and functional efficacy of ISCO's proprietary stem cell-derived neuronal cells. The endpoints of these multi-dose studies include determining cell fate, biodistribution and primate behavioral evaluations using a standardized rating scale to assess potential extrapyramidal side effects associated with the cell engraftment. The first, interim results are expected in Q4 of 2013 with the final results available in Q2 of 2014.

Leading the studies will be Prof. Redmond, a recognized expert in the use of transplanted neural cells to treat parkinsonism in primates and the development of effective replacement strategies using stem cell derived neurons. In his career of over 25 years, Prof. Redmond has made many significant contributions in the field of cellular repair in the nervous system for Parkinson's disease. His accomplishments include establishing one of the first preclinical models for Parkinson's disease in primates, the first successful transplantation of fetal tissue into the brain of a primate and one of the first clinical studies of fetal tissue in Parkinson's patients.

"Building on the results from the successful primate and rodent studies we reported earlier this year, we expect these formal studies to be the final step allowing ISCO to file an IND for Parkinson's disease," said Dr. Ruslan Semechkin, Vice President of Research and Development. "As one of the leaders in this field, it's tremendously exciting for ISCO to have such an experienced and influential clinical scientist as Prof. Redmond to direct this research. His clinical experience will be invaluable as we prepare both our IND submission to the FDA and the subsequent phase I clinical trial," Dr. Semechkin continues.

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.

Forward-looking Statements
Statements pertaining to anticipated developments, the potential benefits of research programs and products, 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," "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, 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.

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