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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