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TaiGen Biotechnology: Excellent Stem Cell Mobilization and Safety Profile for TG-0054


9/28/2009 9:27:34 AM

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.

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&G Pharmaceuticals, achieved non-inferiority in clinical cure rate and safety profile compared with Levofloxacin in its Phase II CAP trial. The company has completed a second phase II study in diabetic foot infection to demonstrate Nemonoxacin's anti-MRSA activity with once-a-day oral dosing. TaiGen is seeking Nemonoxacin licensees for the US, EU and Japan markets. TaiGen also has HCV protease inhibitors in advanced preclinical programs to treat chronic hepatitis C infection.

SOURCE TaiGen Biotechnology Co., Ltd.

CONTACT: Dr. Stephen Ip Sr. VP Global Business Development of TaiGen
Biotechnology Co., Ltd., +886-2-2790-1861, Stephenip@taigenbiotech.com.tw

Web site: http://www.taigenbiotech.com/


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