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  • International Stem Cell Corp. (ISCO) Announces Completion Of Pre-IND Meeting With FDA For Parkinson's Disease Program 0 comments
    Feb 18, 2014 10:27 AM | about stocks: ISCO

    Today before the opening bell, ISCO announced that it had completed a pre-investigational new drug meeting (pre-IND) with the US FDA, thereby completing its discussions with the administration about the company's Parkinson's disease cell therapy. The company received feedback and input from the FDA on its proposed pre-clinical plan, manufacturing approach, and clinical study design necessary to file the IND.

    We're pleased with the outcomes of the meeting with the FDA," said Yale School of Medicine Professor D. Eugene Redmond Jr. MD, who is leading ISCO's pharmacology/toxicology study. "The FDA's feedback has provided clear direction for the remaining studies required for the IND."

    "As this will be the first IND for the Company, we're pleased to have completed this critical milestone," said Dr. Ruslan Semechkin, Chief Scientific Officer of ISCO. "Based on data from our pilot studies, along with the guidance from the FDA, we believe that we're well positioned to successfully transition this program to the clinical stage."

    According to the Parkinson's Disease Foundation, some 7-10 million people worldwide live with Parkinson's disease. Around 1 million of these people live in the United States alone, more than the combined amount of people diagnosed with multiple sclerosis, muscular distrophy, and Lou Gehrig's disease. Direct and indirect costs attributed to Parkinson's disease within the United States are estimated to be nearly $25 billion per year.

    With the pre-IND meeting complete, ISCO will be working toward completion of the Good Laboratory Practice pharmacology and safety studies, including tumorigenicity, toxicology, and tolerability, via use of the human parthenogenetic neural stem cell (hPNSC) product. From the wording in the company's news release, this product is a "type of self-renewing multipotent cell that is a precursor for the major cells of the central nervous system." Pre-clinical pilot studies in rodents and primates have shown that the product's safety, tolerability, and therapeutic benefit. Unlike other stem cell therapies, ISCO's hPNSC product can be delivered in a frozen state to hospitals and other healthcare provider centers. ISCO anticipates the release of interim primate data before the end of March 2014 and top-line final results from these GLP studies later in 2014. From there, it expects to file the IND soon thereafter.

    A comprehensive description of ISCO's hPNSC product and the GMP manufacturing method was published in early 2013 with Prof. Evan Y. Snyder, Director of Stem Cell Research Center at Sanford-Burnham Medical Research Institute.

    For more information, visit: internationalstemcell.com

    QualityStocks provides investor relations services to publicly traded companies in exchange for compensation. This article may be part of our efforts to widen a client's exposure. To read our full disclaimer, visit http://disclaimer.qualitystocks.net

    Stocks: ISCO
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