TaiGen's stem cell mobilizer Burixafor is the company's first fully in-house developed product, a First-in-Class drug with an IND under US FDA. With a variety of potential applications in a number of disease indications, if proven effective in clinical trials, Burixafor will be able to address several unmet medical needs. The molecule is a potent and selective chemokine receptor antagonist which can rapidly mobilize stem cells and progenitor cells from the bone marrow into peripheral circulation. Burixafor also has potential application in chemosensitization treatment of leukemia patients, delaying relapse after chemotherapy. In addition to hematological indications, Taigen and its collaborator have shown Burixafor’s efficacy in animal models of ischemic tissue repair such as strokes, myocardial infarction, and ischemic limb claudication. To this end, TaiGen plans to initiate clinical trials of Burixafor as a chemotherapy sensitizer in China shortly.
For patients undergoing leukemia stem cell transplantation, current conventional therapy is to inject granulocyte colony-stimulating factor (G-CSF) to stimulate the proliferation of hematopoietic stem cells, which are then collected for later transplantation. However, if administration of G-CSF does not bring about the desired result, current practice is to use Mozobil (Sanofi) to then be injected together with G-CSF. Burixafor in comparison could be used as a monotherapy in certain type of patients without combination with G-CSF. Phase II clinical trials are underway in the U.S., with Phase IIa already completed. In December 2013 preliminary data from these trials was presented at American Society of Hematology Annual Meeting in New Orleans, US.
- Indications in Development
- Hematopoietic stem cell transplantation
- Chemosensitization in hematological and solid tumors
- Stem cell collection in healthy individuals for personalized regenerative medicine