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Replies to post #5941 on International Stem Cell Corp. (ISCO)
CARLSBAD, CA--(Marketwired - January 29, 2015) - International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell based therapies and biomedical products, today announced that the company has completed the required preclinical studies and plans to begin the phase 1/2a clinical study of the company's cell therapy for the treatment of Parkinson's disease in Australia within the next few months.
ISCO has formed an Australian subsidiary, Cyto Therapeutics Pty Ltd, to manage the regulatory submission to the Australian Therapeutics Goods Administration (TGA) and the up-and-coming clinical study. The submission includes non-clinical studies evaluating the safety and tolerability of the clinical product, ISC-hpNSC, in different animal species, including non-human primates, along with the chemistry and manufacturing controls and a summary of the clinical study design.
"Having successfully completed the preclinical studies, including the large-scale GLP primate and rodent studies with no adverse events, we believe that our clinical product is safe and that it can have a disease modifying effect as evidenced by increased brain dopamine levels and various behavioral tests," said Ruslan Semechkin Ph.D., ISCO's Chief Scientific Officer.
The company previously announced that the US Food and Drug Administration (FDA) cleared ISCO's parthenogenetic stem cells, the starting material for the production of ISC-hpNSC, for clinical use. ISCO believes that its chemistry and manufacturing controls, which ensure that each batch of cells produced at the company's GMP facility in Oceanside, California is subject to standardized quality control and assurance, meets both the US FDA and the Australian TGA standards.
