TAIPEI, April 30, 2015 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") today announced the initiation of first burixafor trial in China. The study titled "A Phase I/II Study of Burixafor Plus Fludarabine and Cytarabine in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)" is an open-label study to determine the safety and efficacy of burixafor in combination with two chemotherapeutic agents, fludarabine and cytaribine and will enroll up to 15 patients. In addition to maximum tolerated dose of burixafor, other efficacy endpoints such as complete response, disease free survival, and overall survival will also be evaluated. The study will be led by Prof. Wang JianXiang, a distinguished hematologist/oncologist at the Institute of Hematology and Blood Diseases Hospital in Tianjin under a clinical trial authorization for Class 1.1 new drug from China FDA. The Institute belongs to the Chinese Academy of Medical Sciences and Peking Union Medical College and is a key hospital and research institute in China dedicated to hematology and oncology.
Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen 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."
About AML and Chemosensitization
AML is a rapidly progressing cancer of the marrow and blood and one of the four major types of leukemia. AML patients are currently being treated with cytotoxic chemotherapeutic agent or targeted cancer therapy. Rate of relapse remains very high despite emerging new treatment options. According to a report on AML published by the marketing consultant, GlobalData, refractory and relapsed AML remains a high unmet medical need and a main driver of the overall AML market.
One of the major causes of this disease recurrence is the leukemia cells hiding in the bone marrow are less susceptible or resistant to chemotherapeutic agent due to its protective environment. The adhesion and homing of leukemia cells to the bone marrow is mediated by CXCR4/SDF-1 interactions. In preclinical animal models of leukemia, burixafor was shown to mobilize leukemic cells from the bone marrow into the peripheral circulation. When burixafor together with chemotherapeutic agents were given to mice bearing human leukemia, the combination greatly prolonged the survival time in comparison with treatment with chemotherapeutic agents alone.
Burixafor, also known as TG-0054, is a novel, potent and selective chemokine receptor antagonist discovered by TaiGen. Burixafor have already completed one Phase 1 and one Phase 2 study in the US. Another Phase 2 study in autologous stem cell transplantation is ongoing in the US. Other potential indications also include regenerative medicine and ischemic diseases.
About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to TG-0054, TaiGen has two other NCEs in product portfolio: Nemonoxacin (oral formulation) has received NDA approval from Taiwan FDA and pending approval from China FDA; and TG-2349 is a pan-genotypic NS3/4A protease inhibitor currently in Phase 2.
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Peter W. Tsao, PhD, Vice President of Business Development
SOURCE Taigen Biotechnology