Excellent SC Mobilization + Safety Profile for TG-0054
TAIPEI, Taiwan, Sept. 28 /PRNewswire-Asia/ — TaiGen Biotechnology Co., Ltd. announced today that in a phase 1 study in healthy volunteers TG-0054, a chemokine receptor CXCR4 antagonist, was well tolerated and rapidly mobilized stem cells and endothelial progenitor cells from bone marrow into peripheral blood. The number of CD34+ stem cells in circulation after one dose of TG-0054 was equal or higher than reported cell numbers needed for stem cell transplantation in cancer patients. The observed AEs were all mild and transient. A phase 2 study in stem cell transplantation for multiple myeloma, non-Hodgkin lymphoma and Hodgkin disease patients is currently being initiated.
The trial was a randomized, double-blind, placebo-controlled, single intravenous dose study including 64 healthy volunteers in US, to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of TG-0054 in 8 cohorts. The mobilized stem and progenitor cells peaked at 4-6 hours following one single intravenous dose.
“We are greatly encouraged by the phase 1 study results which indicates that TG-0054 has the potential to be used alone, not in combination with G- CSF, for allogenic or autologous stem cell transplantation in cancer patients. This should greatly reduce the hospital and other associated cost for such a procedure. Importantly, the activity and safety profile in the phase 1 study will support our future development of TG-0054 in chemosensitization and tissue ischemia, including myocardial infarction, stroke and severe intermittent claudication. Our preclinical animal disease models and the phase 1 study results lend strong support to clinical development for these clinical indications,” said Dr. Ming-Chu Hsu, Chairman & CEO of TaiGen.