International Stem Cell Corp.
recently took a significant step toward expanding its clinical pipeline when it
submitted preclinical data to the Australian Therapeutic Goods Administration
(TGA) regarding its impending phase I/IIa clinical trial for the treatment of
Parkinson’s disease. According to the submitted data, the company’s nine month
study of 300 rodents resulted in no tumors being observed in any of the animal
subjects, demonstrating the safety and efficacy of its human neural stem cells
(hpNSCs), which were derived using ISCO’s proprietary parthenogenetic stem cell
platform. The company predicts that this will be the final submittal required
prior to the initiation of clinical studies.
“We expect that this study report
will address the remaining safety elements necessary for regulatory approval,”
Dr. Ruslan Semechkin, chief science officer of ISCO, stated in a news release.
“Having provided this final submission we now look forward to receiving TGA
authorization to begin our phase I/IIa clinical trial in Australia.”
If approved to begin clinical
trials, ISCO will be in a strong strategic position to enter the Australian
Parkinson’s disease treatment market in the future, which could provide the
company with a substantial opportunity to achieve sustainable international
growth. According to a report by Parkinson’s Queensland, approximately one in
350 Australians live with Parkinson’s disease, making it the country’s second
most common neurodegenerative disorder. In 2011, the debilitating disease accounted
for an estimated $480 million in national health system costs, further
demonstrating the market potential of ISCO’s groundbreaking treatment option
following regulatory approval.
ISCO’s proprietary approach to stem
cell research, parthenogenesis, directly addresses many of the limiting factors
typically associated with regenerative medicine. In particular, the company’s
parthenogenetic homozygous stem cell line can be a source of therapeutic cells
for hundreds of millions of individuals with minimal risk of immune rejection
following transplantation. Additionally, since its cells are derived from
unfertilized eggs, ISCO avoids many of the ethical issues associated with
embryonic stem cells without sacrificing their transformative pluripotent
qualities.
For prospective shareholders, the
company’s strong progress toward expanding its market share in the global
regenerative medicine industry could foreshadow an opportunity for sustainable
returns in the months to come. Look for ISCO to build on this progress moving
forward as it eagerly awaits TGA authorization to begin its pivotal clinical
development program in the Australian market.
For more information, visit
www.internationalstemcell.com
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