TAIPEI, Taiwan, Dec. 7 TaiGen Biotechnology Co., Ltd.announced today the presentation of Phase I and preclinical data for TG-0054,the Company's chemokine receptor CXCR4 antagonist and a novel, potent stemcell mobilizer, at the ASH Annual Meeting held in New Orleans, the US, fromDecember 5 to 8, 2009.
The clinical data of Phase 1 study will be presented. In this randomized,double-blind, placebo-controlled, sequential ascending single intravenous dosestudy, TG-0054 exhibited excellent and favorable safety, tolerability,pharmacokinetics (PK), and pharmacodynamics (PD) profile. A maximallytolerated dose (MTD) was established. Good tolerability was observed. PKparameters showed dose proportionality over the dose range studied. PD resultsshowed potent, dose-dependent mobilization of CD34+ hematopoietic stem cellsand CD133+ endothelial progenitor cells into peripheral blood circulation.
The preclinical data will be reported on in vitro assays and in vivostudies in mouse models. TG-0054 demonstrated potent and selectiveantagonistic activities against CXCR4 in vitro. Significant mobilization ofCD34+ hematopoietic stem cells and CD133+ endothelial progenitor cells wasobserved when TG-0054 was used alone or combined with G-CSF in preclinicalmodels.
The preclinical and Phase I results support further clinicalinvestigation. The Phase 2 study entitled "A Phase II, Randomized, Open-Label,Multi-Center Study to Evaluate the Safety, Pharmacokinetics, and HematopoieticStem Cell Mobilization of TG-0054 in Patients with Multiple Myeloma,Non-Hodgkin Lymphoma or Hodgkin Disease" will begin to enroll patients inDecember, 2009.
About TaiGen Biotechnology
TaiGen Biotechnology ( http://www.taigenbiotech.com/ ) is a leadingdevelopment stage pharmaceutical company based in Taiwan with a wholly-ownedsubsidiary in Beijing, China. The company has a full capacity in discoveryresearch and clinical development in China/Taiwan/US. Its current pipelineincludes therapeutics for infectious diseases, diabetic complications andcancer for the worldwide market. In addition to TG-0054, Nemonoxacin, a novelbroad-spectrum non-fluorinated quinolone with anti-MRSA activity andin-licensed from P&G Pharmaceuticals, achieved non-inferiority in clinicalcure rate and safety profile compared with Levofloxacin in its Phase II CAPtrial. The company has completed a second phase II study in diabetic footinfection to demonstrate Nemonoxacin's anti-MRSA activity with once-a-day oraldosing. TaiGen is seeking Nemonoxacin licensees for the US, EU and Japanmarkets. TaiGen also has HCV protease inhibitors in advanced preclinicalprograms to treat chronic hepatitis C infection.ASH 2009 Meeting Presentation: Clinical Oral presentation: TG-0054, a Novel and Potent Stem Cell Mobilizer, Displays Excellent PK/PD and Safety Profile in Phase 1 Trial Tuesday, December 8, 2009: 7:30 AM-9:00 AM Preclinical Poster: Rapid Mobilization of Murine Hematopoietic Stem and Progenitor Cells with TG-0054, a Novel CXCR4 Antagonist (Poster Board number: III-479) Monday, December 7, 2009: 6:00 PM-8:00 PM
SOURCE TaiGen Biotechnology Co., Ltd.