CARLSBAD, CA – (Marketwired) – 08/21/13 – International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a California-based biotechnology company developing novel stem cell-based therapies, announced today that it has entered into a master clinical research agreement with Duke University to conduct clinical trials research in Parkinson’s disease using ISCO’s innovative neural stem cell product.
Mark Stacy, M.D., Vice Dean for Clinical Research, Neurology at Duke University School of Medicine and an internationally recognized leader in the field of Movement Disorders, including Parkinson’s disease, will be the study’s principal investigator. The research will be coordinated by the Duke Clinical Research Institute (DCRI), the world's largest academic clinical research organization, which is internationally recognized for conducting groundbreaking clinical trials.
“We are pleased to have the opportunity to conduct the clinical trials related to ISCO’s investigation stem cell therapy in Parkinson’s disease patients,” said Stacy. “Duke has an exceptional clinical trials team and we look forward to characterizing and understanding the safety and efficacy profile of this agent in the clinical trials setting.”
“We’re tremendously excited to be working with such a world-class clinical research organization as Duke University,” commented Dr. Ruslan Semechkin, Vice President of Research and Development at International Stem Cell Corporation. “Dr. Stacy and his team have made numerous significant contributions in the field of Parkinson’s disease research which together with Duke’s extensive clinical expertise in cell therapy clinical trials and the extensive patient population, gives us an outstanding opportunity to evaluate our revolutionary stem cell therapy.”
Stacy has extensive clinical trials experience, primarily involving neuro-protective and neuro-regenerative therapies and developing biomarkers for early diagnosis in Parkinson’s disease. He has published more than 100 peer-reviewed scientific papers in the field and has served as an advisor to a number of companies. He has participated in more than 100 clinical trials.
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 mulitpotent 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, Vice President, R&D
Senior Vice President