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news.TaiGen Biotechnology has initiated the enrollment for the TG-0054 Phase I trial under an IND from the FDA. TG-0054 will initially be developed for the indication of stem cell transplantation in cancer patients.
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The randomized, double-blinded, placebo-controlled, sequential ascending single intravenous dose study of TG-0054 will evaluate the safety, tolerability, pharmacokinetics and the biomarkers, the CD34+ stem cells and the CD133+ progenitor cells in peripheral circulation, in healthy subjects. Results from this study are expected in fourth quarter of 2008.
TG-0054 is a potent and selective inhibitor for the binding of the chemokine cell-surface receptor CXCR4 to its ligand SDF-1 and efficiently mobilizes stem cells (CD34+) and endothelial progenitor cells (CD133+) from bone marrow into peripheral circulation in a mouse model.
Ming-Chu Hsu, chairman and CEO of TaiGen, said: “In addition to stem cell transplantation, TaiGen is prepared to develop TG-0054 as the first-in-class therapy for age-related macular degeneration and critical limb ischemia. This is the first of a series of in-house derived drug candidates that TaiGen plans to take into clinical development in the next one to two years.”