International Stem Cell Corporation Advances Parkinson's Disease Program Towards IND Stage
Published: Sep 09, 2013
CARLSBAD, CA--(Marketwired - September 09, 2013) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com), a California-based biotechnology company developing novel stem cell-based therapies, announced today further progress in its Parkinson's disease program with a recently held key opinion leader meeting facilitated by the study's principal investigator, Dr. Mark Stacy of Duke Medicine.
The meeting was a significant step towards clinical studies to evaluate the use of stem cell-derived neuronal cells to treat Parkinson's disease (PD). By bringing together leading experts from throughout North America in the field of cell therapy and movement disorders, ISCO gains critical feedback and guidance that can be included in the final pre-clinical primate studies and the design of the first-in-man study, which is expected to begin in 2014.
"This is an interesting new approach for the treatment of PD," said Stacy, Vice Dean for Clinical Research, Neurology at Duke University School of Medicine. "This meeting increases the chances of a successful clinical outcome by allowing us to not only build on previous studies, but also gain in-depth insight from some of the principal clinicians and neurosurgeons working in this field."
The participants, consisting of a number of pre-eminent clinicians, some of whom have conducted cell therapy trials in PD using fetal-derived tissue, discussed the study design for the first-in-man trial, including the specific sites in the brain where the cells will be implanted, the necessity for placebo controls, and the duration that may be required to see clinically meaningful changes.
"There is still much debate in the literature concerning the most effective ways to treat Parkinson's patients with human cells. Gathering such a distinguished clinical group together, although challenging, helped answer a number of open questions regarding the phase I clinical study," commented Dr. Ruslan Semechkin, Chief Scientific Officer at International Stem Cell Corporation. "It's a testament to Dr. Stacy and Duke's reputation in this area to be able to draw together such experience; we feel very confident that we have the right approach and every chance for a successful IND and subsequent phase I study."
ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC), a novel therapeutic cellular product derived from the company's proprietary histocompatible human pluripotent stem cells. The hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (1) differentiate into dopaminergic neurons, and (2) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new and revolutionary opportunity for the treatment of Parkinson's disease, especially in cases where current dopamine-replacement approaches fail to adequately control the symptoms.
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.
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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International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Dr. Ruslan Semechkin
Chief Scientific Officer
Senior Vice President
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