In order to manage the regulatory submission to the Australian Therapeutics Goods Administration (TGA) and the up-and-coming clinical trial, ISCO has established an Australian subsidiary named Cyto Therapeutics.
The regulatory submission includes non-clinical studies evaluating the safety and tolerability of 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.
ISCO chief scientific officer Ruslan Semechkin said: "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."
Earlier, the US Food and Drug Administration (FDA) had cleared the company’s parthenogenetic stem cells, the starting material for the production of ISC-hpNSC, for clinical use.
The company believes that its chemistry and manufacturing controls, which ensure that each batch of cells produced at the company’s GMP facility in Oceanside is subject to standardized quality control and assurance, meets both the FDA and the Australian TGA standards.