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TaiGen begins Phase I/II trial of burixafor in China to treat acute myeloid leukemia

TaiGen Biotechnology Company has started a Phase I/II trial of burixafor in combination with two chemotherapeutic agents fludarabine and cytarabine in adults with relapsed or refractory acute myeloid leukemia (AML) in China.

Burixafor (TG-0054) is a new, potent and selective chemokine receptor antagonist discovered by TaiGen.

Around 15 patients will be enrolled in this open-label trial, which is designed to determine the safety and efficacy of burixafor plus fludarabine and cytarabine.

The trial will evaluate maximum tolerated dose of burixafor, as well as other efficacy endpoints such as complete response, disease free survival and overall survival.

Institute of Hematology and Blood Diseases Hospital hematologist/oncologist professor Wang JianXiang will lead the trial under a clinical trial authorization for Class 1.1 new drug from China FDA.

TaiGen chairman and CEO Dr Ming-Chu Hsu said: "Chemotherapy and stem cell transplantation are the mainstay of leukemia treatment. We know from our clinical study to date, burixafor can mobilized sufficient stem cells necessary for hematopoietic stem cell transplantation.

"This study will give us the additional information on the utility of burixafor as a chemosensitizer in combination with chemotherapy and could greatly expand the indications and increase the market potential in hematology/oncology."

The company said that burixafor have already completed one Phase I and one Phase II trial in the US, with another Phase II trial in autologous stem cell transplantation is ongoing in the country.