State of development

Manufacturing

some samples Symbiotec has successfully established the complete manufacturing process of ONCOHIST, comprising a fermentation process in E. coli as well as the complete downstream processing, including analytical methods and quality control. Large-scale manufacturing of cGMP-grade material for clinical trials has been developed by Eurogentec S.A. Belgium.

Preclinical testing

The safety of ONCOHIST was effectively proven in several toxicology studies. Toxicokinetic studies demonstrate that ONCOHIST is widely distributed in the body, including bone marrow, and has a favourable half-life. Accumulation of ONCOHIST in any organ or tissue was not observed.

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