CARLSBAD, CA - (Marketwired) - 3/4/2014 - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, today announced positive data from the first interim analysis of the ongoing IND-enabling pharmacology/toxicology primate study being conducted under the supervision of Professor D. Eugene Redmond Jr. MD, of Yale University Medical School.
“The initial data from this large controlled study is very encouraging” said Professor Redmond, “In Parkinson’s disease research non-human primate data are considered the gold standard and are by far the best indicator of likely outcomes in humans”
The majority of the animals in this ongoing study have shown significant improvement in parkinsonism, including a return of many normal behaviors. The study consist of 18 primates divided into three cohorts, a control group and two treatment groups with the treatment groups receiving different doses of human neural stem cells (hPNSC) derived from ISCO’s proprietary parthenogenetic stem cell line.
This study design uses an extremely well validated and widely published non-human primate model of Parkinson’s disease. The symptoms of the disease are induced by the administration of a neurotoxin which selectively destroys the same type of neuron that is affected in the human condition. This results in the monkeys exhibiting all the classic symptoms of PD from akinesia, rigidity gait abnormalities to tremors, freezing and fine motor coordination.
Dr. Ruslan Semechkin, Chief Scientific Officer for the Company commented: “This pharm/tox primate study, together with our rodent tumorigenicity study, is fundamental for ISCO’s planned IND submission – which we believe will be the first IND in the world using pluripotent stem cell-derived therapeutic cells to treat Parkinson’s disease. We anticipate providing further updates on this study in the second and third quarters, to report the final results towards the end of 2014 and to file the IND soon thereafter.”
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, UniStemCellTM. 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.
According to the Parkinson’s Disease Foundation, an estimated seven to 10 million people worldwide live with PD, with as many as one million of those in the United States alone, more than the combined total of people diagnosed with multiple sclerosis, muscular distrophy, and Lou Gehrig’s disease. The total direct and indirect cost of Parkinson’s disease is estimated to be nearly $25 billion per year in the United States alone.
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. hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to (i) differentiate into dopaminergic (DA) neurons and (ii) express neurotrophic factors such as glial derived neurotrophic factor (GDNF) and brain derived neurotrophic factor (BDNF) to protect the nigrostriatal system, offers a new opportunity for the treatment of Parkinson's disease, especially in cases where current small molecule approaches fail to adequately control the symptoms.
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Safe harbor statement
Statements pertaining to anticipated developments, expected progress of our Parkinson’s disease research and development program and related planned regulatory filings, 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 clinical trials and the development and/or commercialization of potential products, the management of collaborations, 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.
International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Dr. Ruslan Semechkin
Chief Scientific Officer