CrystalGenomics said Tuesday that its U.S. partner, Aptose Bioscience has injected the first dose of CG-806, a leukemia treatment candidate, to a patient participating in the U.S. phase 1a and 1b clinical trials.
The company plans to confirm the safety, tolerability, pharmacokinetics, and pre-efficacy assessment in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and non-Hodgkin lymphoma (NHL) through the clinical trial.
The safety and predictable pharmacokinetic data, which the company will file to the U.S. Food and Drug Administration for a separate phase clinical trial, will provide human 1 clinical trial for patients with recurrent or acute myeloid leukemia and myelodysplastic syndrome.
“We have been preparing and looking forward to testing CG-806 on a human body for a long time,” Aptose Biosciences CEO William Rice said. “CG-806 is a targeted therapy that inhibits Bruton tyrosine kinase (BTK), FMS-like tyrosine kinase 3 (FLT3), and aurora kinase (AURK).”
The drug is a revolutionary blood cancer treatment that has an excellent anticancer effect, by suppressing multiple cancer signal pathway that cancer cells cause for survival and also has precise safety to avoid toxicity related target, he added.
CrystalGenomics licensed out CG-806’s global sales rights, except for Korea and China, to Aptose Biosciences for 360 billion won ($319.1 million) in June 2016.
The two companies expect CG-806 will become an innovative treatment for AML and CLL, which are incurable hematological malignancies, as the drug has shown positive results in the preclinical trials.
The treatment can also offer various benefits such as quick examination, conditional approval after clinical phase 2 trial, and monopoly sale for seven years as it received Orphan Drug Designation from the FDA.
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