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FDA grants Orphan Drug Designation to CG’806 for the treatment of AML
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Last month, the US Food and Drug Administration (FDA) granted Orphan Drug Designation to CG’806, a multi-kinase inhibitor, for the treatment of patients with Acute Myeloid Leukemia (AML).
CG’806 is a highly potent, first-in-class, oral inhibitor of FMS like Tyrosine Kinase 3 (FLT3)/ Bruton’s Tyrosine Kinase (BTK). Preclinical studies have demonstrated that, CG’806 can inhibit AML harbouring FLT3- Internal Tandem Duplication (FLT3-ITD), Tyrosine Kinase Domain (TKD) mutations or both by inhibiting FLT3/BTK/Aurora Kinase (AuroK) activation. Additionally, CG’806 exhibits a profound suppression of cell proliferation in FLT3-mutant AML cells.
Aptose Biosciences, the drug manufacturers, noted that based on the encouraging preclinical data of CG’806, they are eager to begin clinical trials in AML later this year.
- GlobeNewswire: FDA Grants Orphan Drug Designation to Aptose Biosciences for CG’806 in Acute Myeloid Leukemia. 2017 December 26. https://globenewswire.com/news-release/2017/12/26/1274572/0/en/FDA-Grants-Orphan-Drug-Designation-to-Aptose-Biosciences-for-CG-806-in-Acute-Myeloid-Leukemia.html. [Accessed 2018 Jan 4].
- Yu. G. et al. CG '806, a Novel Pan-FLT3/BTK Multi-Kinase Inhibitor, Induces Cell Cycle Arrest, Apoptosis or Autophagy in AML Cells Depending on FLT3 Mutation Status. Blood. 2017 130: 4629.
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