August 17, 2015 (Investorideas.com stocks newswire)
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
http://health.einnews.com/article/281578200/ZJ4F-UybJ84ls5bS
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