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.
About TaiGen Biotechnology
TaiGen Biotechnology ( http://www.taigenbiotech.com/ ) is a leading
development stage pharmaceutical company based in Taiwan with a wholly-owned
subsidiary in Beijing, China. The company has a full capacity in discovery
research and clinical development in China/Taiwan/US. Its current pipeline
includes therapeutics for infectious diseases, diabetic complications and
cancer for the worldwide market. In addition to TG-0054, Nemonoxacin, a novel
broad-spectrum non-fluorinated quinolone with anti-MRSA activity and in-
licensed from P
