TaiGen Initiates Phase I Trial Of The Stem Cell Mobilizer TG-0054
April 8, 2008
TaiGen Biotechnology Co., Ltd. announced the enrollment for the TG-0054 phase I trial under an IND from the US FDA. 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. TG-0054 will initially be developed for the indication of stem cell transplantation in cancer patients.
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 4Q 2008.
“We are very pleased to have an exciting addition to our clinical pipeline. 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,” stated Dr. Ming-Chu Hsu, Chairman and CEO of TaiGen. “This is the first of a series of in-house derived drug candidates that TaiGen plans to take into clinical development in the next 1-2 years.”
About TaiGen Biotechnology Co., LTD
TaiGen Biotechnology is a leading development stage pharmaceutical company based in Taiwan with a wholly-owned subsidiary in , China. The company is developing novel therapeutics to treat infectious diseases, diabetic complications and cancer for the worldwide market. TaiGen has a full capacity in new drug R&D and clinical development in China, Taiwan, US and other countries. The company’s in-house R&D has developed first-in-class drug candidates and the first such drug, TG-0054, is currently in phase 1 trial in the US. TaiGen plans to develop TG-0054 for stem cell transplantation, critical limb ischemia and age-related macular degeneration. TaiGen in-licensed nemonoxacin, a novel broad-spectrum antibacterial with anti-MRSA activity, from P&G Pharmaceuticals. The company also announced today the top-line result of the first phase II study of nemonoxacin in community-acquired pneumonia. Nemonoxacin achieved the non-inferiority clinical curate compared with levofloxacin and two drugs have comparable safety profile in the phase II trial. P&G and TaiGen are seeking nemonoxacin licensees or co-development partners for the US, EU and Japan market. TaiGen has advanced programs in preclinical development for chronic hepatitis C infection (target at the viral protease) and solid tumors.
TaiGen Biotechnology
