US FDA Approves Zhaohe Cao-based Botanical Drug as an Investigational New Drug for Cancer Therapy
A botanical extract derived from the edible medicinal plant Crassocephalum crepidioides (named “Zhaohe Cao” in Mandarin) has received approval from the US Food and Drug Administration (FDA) for investigation in humans for cancer therapy.
Dr. Lie-Fen Shyur, a Research Fellow at the Agricultural Biotechnology Research Center discovered that a galactolipid-enriched fraction from a Zhaohe Cao-derived bioactive extract with defined chemical fingerprints had novel anti-inflammatory and anti-melanoma bioefficacy. Dr. Shyur’s laboratory found that the extract had efficacy in inhibiting melanoma growth and organ (e.g., lung and brain) metastases, prolonging life and reducing anti-cancer drug side effects in animals. Part of the research results have been published in Cancer Research, and the extract has received two US patents and one ROC patent, and won the 2014 National Invention and Creation Award.
Through technology transfer and collaboration with the research team at the Development Center for Biotechnology (DCB), Dr. Shyur and her lab members helped the DCB to scale-up and establish a Chemical Manufacturing Control (CMC) protocol for mass production of the bioactive Zhaohe Cao extract, validate its anti-tumor activities, and complete toxicology analyses to prove its safety in animals. In March 2017, the Zhaohe Cao-based anti-cancer extract (designated DCB-BO1301) received US Food and Drug Administration (US FDA) approval as a botanical Investigational New Drug (IND) for cancer therapy. IND status is authorization from the US FDA to administer an investigational drug or biological product to humans. Such authorization must be secured prior to administration of any new drug or biological product in the US.
In addition, Academia Sinica and the DCB have co-exclusively licensed the Zhaohe Cao-based anti-cancer botanical drug (DCB-BO1301) technology to a Taiwanese pharmaceutical company for a phase Ib/IIa clinical trial in cancer patients in local hospitals. The trial is expected to start in early 2018.
This Zhaohe Cao-based anti-cancer botanical drug is an exciting pioneering example in Academia Sinica and can serve as a role model for translational herbal medicine research. It serves as an example of how the innovative laboratory research and pre-clinical study results (upstream discovery research) of PIs can develop into collaboration and co-development with the non-profit governmental organization DCB for subsequent middle-stream (scale-up) research and development, and then be taken over by a local pharmaceutical company to translate potential herbal medicines from the bench top to human clinical trials against cancer diseases. The Good Agricultural and Collection Practices (GACP) for production of anti-cancer botanical drugs according to World Health Organization guidelines will be followed for the Zhaohe Cao plant materials through collaboration with the Taichung District Agricultural Research and Extension Station, Council of Agriculture. The R&D of Zhaohe Cao-based anti-cancer botanical drug is anticipated to help and promote the economy and profit the agriculture of Formosan medicinal plants and strengthen the competiveness of Taiwanese pharmaceutical industry for botanical drug development and marketing.
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