International Stem Cell Corporation, 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."