Last month, International Stem Cell Corp. (OTCQB: ISCO)
published the results of its 12-month pre-clinical, non-human primate study
demonstrating the safety and efficacy of its proprietary human parthenogenetic
stem cell-derived neural stem cells (ISC-hpNSC™). These findings highlighted
the efficacy of transplanting ISC-hpNSC into non-human primates induced with
moderate to severe clinical Parkinson’s disease symptoms, as well as serving as
the basis of ISCO’s application to the Australian regulatory authorities to
move forward with clinical trials, which was approved in mid-December.
“The publication of the data in the peer-reviewed and
highly-respected journal, Cell Transplantation, brings to conclusion the
preclinical stage of ISCO’s Parkinson’s disease program,” Russell Kern, Ph.D.,
chief scientific officer of ISCO, stated in a recent news release. “The data
provides further evidence that parthenogenetic neural stem cells can be
effective in treating the symptoms of Parkinson’s disease.”
In recent weeks, ISCO has looked to build on this progress
through the commencement of a phase I clinical trial of ISC-hpNSC for the
treatment of moderate to severe Parkinson’s disease. The company announced the
start of enrollment for this trial in early March, and it expects to present
preliminary clinical data from this study as early as the fourth quarter of
this year.
ISCO has also continued to make strides from a financial
standpoint. In the first quarter of 2016, the company announced entry into
definitive agreements with two institutional healthcare investors and
management for the private placement of $6.3 million of ISCO’s convertible
preferred stock, as well as purchase warrants covering up to $25.7 million of
common stock. When combined with the revenues generated from its two
wholly-owned subsidiaries, both of which remain profitable according to first
quarter operating results, ISCO is in a favorable financial position as it
moves toward the start of its phase I clinical trial at Australia’s Royal
Melbourne Hospital.
If clinical trials prove successful, ISC-hpNSC will address
a currently underserved indication that affects more than seven million people
worldwide. According to data from the Parkinson’s Disease Foundation, the
combined direct and indirect costs associated with the management of
Parkinson’s is estimated at $25 billion per year in the United States alone. Currently,
medication costs for an individual living with the neurodegenerative disease
average roughly $2,500 annually, despite the fact that there is no available
cure.
“We are very pleased to start the first human study of
ISC-hpNSC’s for the treatment of this debilitating disease,” Andrey Semechkin,
Ph.D., chief executive officer of ISCO, stated in a news release late last
year. “There is a large unmet medical need for new treatments that may halt or
reverse the progression of Parkinson’s disease and we believe our human neural
stem cells may fill this need for the millions of people with this disease.”
For more information, visit www.internationalstemcell.com
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