The aim of the project is to perform pre-clinical toxicology of a novel anti-brain tumor drug candidate, Glioblast-13. Glioblast-13 has been uniquely designed to kill specifically cancer cells while sparing normal tissues. In previous studies, Glioblast-13 showed prominent anti-tumor activity in vivo. The current experiments will establish the maximum tolerated dose (MTD) in rodents receiving Glioblast-13 intracranially and intravenously. The MTD will be the LD10 established in treated animals. In addition, normal tissues of the central nervous system and 22 peripheral organs will be analyzed by histopathology for the evidence of toxicity. In particular, the liver will be observed for general signs of toxicity and reversibility of the damage, if this occurs. These studies will enable us to prepare an IND application to the FDA for the initial clinical trials to be conducted in patients with incurable brain tumors.
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