International Stem Cell Corporation (OTCBB:ISCO), www.internationalstemcell.com, announced today that its oocyte collection and activation protocol has received the approval of an Institutional Review Board (IRB). IRB review and approval is a Federal requirement for all studies enrolling human subjects, and ensures appropriate subject safety and monitoring to protect subjects from unnecessary medical risks. 'Obtaining IRB approval for our oocyte collection and activation protocol is a major step forward towards the goal of building a viable bank of human parthenogenetic stem cells,' said Dr. Simon Craw, Vice President of ISCO.
ISCO's breakthrough discoveries have resulted in unique stem cells carrying distinct advantages over other human pluripotent stem cells. ISCO uses unfertilized eggs (oocytes) to create human 'parthenogenetic' stem cells (hpSCs). Like human embryonic stem cells (hESCs), hpSCs are pluripotent, i.e. they have the capacity to become almost any cell type in the body, yet avoid ethical issues associated with use or destruction of viable human embryos. Unlike hESCs, hpSCs can be created in a form such that they can be immunologically matched to millions of individuals. This makes possible, for the first time, the establishment of a bank containing a manageable number of stem cell lines immune matched to a large patient population.
ISCO also announced that Prof. M. Kalichman of the University of California San Diego and Director of the San Diego Research Ethics Consortium has been engaged to provide help in creating an effective system for the ethical review of ISCO's donor recruitment processes including facilitating Stem Cell Research Oversight (SCRO) committee review and approval. SCRO committee review involves the analysis and approval of the scientific rationale, including any ethical considerations associated with stem cell research. The SCRO committee membership is mandated to include an ethicist, an assisted reproductive technology expert, appropriate scientific expertise, a patient advocate and a non-scientific member of the public.
Prof. Kalichman said, 'I look forward to working with International Stem Cell Corporation to help with both identifying and recommending solutions to the challenges of conducting ethically responsible research with human stem cells.'
These achievements mark major milestones along ISCO's strategic path of leveraging its discoveries and intellectual property to create a bank of immune matched pluripotent human stem cells and their therapeutic derivatives that can be used for clinical research and ultimately as a valuable medical resource to the growing field of regenerative medicine.
ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available at ISCO's website, www.internationalstemcell.com.
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Statements pertaining to anticipated technological developments and therapeutic applications, the potential benefits of collaborations, affiliations, 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," "should," "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, uncertainty in the results of clinical trials or 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 these forward-looking statements.
Key Words: Stem Cells, Biotechnology, Parthenogenesis
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
Simon Craw, PhD, Vice President
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