International Stem Cell Corp. (ISCO) Reports Positive Results of Parkinson’s Disease Study
International Stem Cell Corp., a California-based biotechnology company developing novel stem cell based therapies, just announced the completion of the acute toxicity study of its proposed clinical product to treat Parkinson’s disease. The recently completed IND-enabling study transplanting rodents with human neural stem cells, derived from ISCO’s proprietary parthenogenetic stem cell platform, showed that the cells are well tolerated even at high doses up to the equivalent of 2.2 billion cells in humans. The program continues to progress according to the plan outlined with the FDA at the pre-IND meeting as reported in February 2014. The company anticipates providing an update early next quarter.
“I’m pleased that we have successfully achieved another important milestone in our Parkinson’s disease program. A critical part of the development process, and the preparations for the IND submission, was to establish the highest tolerated dose of our clinical product in rodents,” stated Dr. Ruslan Semechkin, ISCO’s Chief Scientific Officer. “The results of this study show that the doses we will be proposing to the FDA in our phase I clinical study design for the treatment of Parkinson’s disease are well below the safety threshold.”
The study consisted of 19 immune deficient rodents divided into four cohorts, a control group and three treatment groups receiving escalating doses of human parthenogenetic neural stem cells (hPNSC). Animals received stereotactic injections of hPNSC in the striatum and substantia nigra. The rodents were observed for seven days post transplantation and demonstrated normal appearance and behaviors. Necropsies showed no abnormal tissues or tumors after sacrifice. Detailed immunohistochemical analysis demonstrated that the majority of the implanted cells survived the surgery and engrafted into the host brain tissue.
According to the Parkinson’s Disease Foundation, an estimated seven to 10 million people worldwide live with Parkinson’s disease, 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 dystrophy, 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.
For more information on the company, visit www.internationalstemcell.com
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