CARLSBAD, CA--(Marketwired - February 03, 2015) - International Stem Cell Corporation (ISCO), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, today announced that the Company has completed manufacturing of the cell bank of clinical-grade human neural stem cells using its patented process for the recently announced phase 1/2a clinical trial in Parkinson's disease. The cell bank contains over 2.6 billion human cells, sufficient to meet the company's foreseeable clinical trial requirements.
"Completing the production of clinical-grade cells using the previously published protocol is one of the final steps before starting our clinical program," said Ruslan Semechkin, Ph.D., ISCO's Chief Scientific Officer. "Because of the complexity involved in manufacturing live human cell products, having our own GMP facility is not only a strategic advantage, but also allows us to control the production costs. We continue to anticipate, subject to regulatory agency approval, beginning the clinical trial in early 2015 and will provide a further update in the near future."
ISCO's master cell bank of human parthenogenetic neural stem cells (ISC-hpNSC) is produced in compliance with current good manufacturing practices (cGMPs) and the chemistry and manufacturing controls (CMC) discussed in the previously reported pre-IND meeting with the FDA. The cells are karyotypically normal hpNSCs and free of measurable contaminants of human or animal origin. The production of hpNSCs from undifferentiated pluripotent human parthenogenetic stem cells in the master cell bank uses qualified reagents and a standardized protocol developed by ISCO. The undifferentiated human stem cells are derived from the parthenogenetic line and were recently cleared by the FDA for use in clinical trials. Each batch of hpNSC is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before clinical use. The existing master cell bank and current production scale are sufficient to supply our anticipated product needs through pivotal clinical trials. The cell bank was produced at the company's state of the art GMP manufacturing facility located in Oceanside, Calif.
About human parthenogenetic neural stem cells
ISC-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 ISC-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 doses ranging efficacy to be used to design the first clinical trial in Parkinson's disease 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 backgrounds, 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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Statements pertaining to anticipated developments, the expected timing and results of clinical studies and 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.