International Stem
Cell Corp., a biotechnology company specializing in the therapeutic
applications of human stem cells and the development and commercialization of
cell-based biomedical products, today issued a press release announcing 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,” stated 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.”
Most of the animals
in this ongoing study have shown significant improvement in parkinsonism, as
well as returned to 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.”
For more
information, visit www.internationalstemcell.com
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