International Stem
Cell Corp. recently announced positive data results from the first interim
analysis of the ongoing IND-enabling pharmacology/toxicology primate study
conducted under the supervision of Professor D. Eugene Redmond Jr. MD, of Yale
University Medical School. The company is a biotechnology company focused on
therapeutic applications of human stem cells and the development and
commercialization of cell-based biomedical products.
Professor Redmond
commented, “The initial data from this large controlled study is very
encouraging. 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.”
Many of the animal
subjects in the study have shown remarkable improvement in parkinsonism, while
many returned to normal behaviors. The study consisted of 18 primates that were
divided into three groups – 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.
The design of this
study uses a highly 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.
In a comment by Dr.
Ruslan Semechkin, Chief Scientific Officer for the company, it was stated,
“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.”
For more
information, visit www.internationalstemcell.com
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