SOURCE: International Stem Cell Corporation

International Stem Cell Corporation

July 30, 2015 08:30 ET

International Stem Cell Corporation Submits Remaining Requested Safety Study Report for Clinical Trial Authorization

CARLSBAD, CA--(Marketwired - July 30, 2015) - International Stem Cell Corporation (ISCO), a California-based biotechnology company developing novel stem cell based therapies and biomedical products, announced today the submission of the final safety (tumorigenicity) and biodistribution study report that has been requested by the Australian Therapeutics Good Administration (TGA) prior to initiation of the company's Phase 1/2a clinical trial for the treatment of Parkinson's Disease.

"We expect that this study report will address the remaining safety elements necessary for regulatory approval. Having provided this final submission we now look forward to receiving TGA authorization to begin our Phase 1/2a clinical trial in Australia," said Dr. Ruslan Semechkin, ISCO's Chief Scientific Officer.

The results of the 9-month safety GLP study of 300 rodents demonstrate that no tumors were observed in any of the animals transplanted with human neural stem cells (hpNSCs), derived from ISCO's proprietary parthenogenetic stem cell platform.

hpNSCs are a novel therapeutic cellular product derived from the Company's proprietary human pluripotent stem cells. Neural stem cells are self-renewing multipotent cells that are precursors for the main cell types of the central nervous system. The ability of hpNSCs to differentiate into dopaminergic neurons and express brain-protecting neurotrophic factors offers a new opportunity for the treatment of Parkinson's disease. ISCO's preclinical program includes animal studies to assess the safety and tolerability of our novel cell therapy as well as dose ranging efficacy that were used to design our first clinical trial in Parkinson's disease patients.

About Parkinson's disease
According to the Parkinson's Disease Foundation, an estimated seven to 10 million people worldwide live with Parkinson's disease, with as many as one million of those in the United States alone, more than the combined total of people diagnosed with multiple sclerosis, muscular dystrophy, and Lou Gehrig's disease. Parkinson's disease is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine, and is characterized by symptoms including tremors at rest, rigidity and impaired movement.

The standard of care for the treatment of PD symptoms is oral levodopa (L-dopa). Oral dosing of L-dopa is associated with wide variability in the timing and amount of L-dopa absorption into the bloodstream, leading to the unreliable control of symptoms resulting in the emergence of OFF episodes, periods of time during which Parkinson's disease symptoms reemerge despite L-dopa treatment. These OFF episodes, which increase in frequency and severity during the course of the disease, are experienced by a majority of PD patients and are considered one of the greatest unmet medical needs facing PD patients.

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). hpSCs avoid 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 and companyblog.intlstemcell.com.

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Forward-looking Statements
Statements pertaining to anticipated developments, the expected timing and results of preclinical studies and subsequent regulatory filings, 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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