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 stem cell mobilizer, at the ASH Annual Meeting held in New Orleans, the US, from December 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 dose study, TG-0054 exhibited excellent and favorable safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) profile. A maximally tolerated dose (MTD) was established. Good tolerability was observed. PK parameters showed dose proportionality over the dose range studied. PD results showed potent, dose-dependent mobilization of CD34+ hematopoietic stem cells and CD133+ endothelial progenitor cells into peripheral blood circulation.
The preclinical data will be reported on in vitro assays and in vivo studies in mouse models. TG-0054 demonstrated potent and selective antagonistic activities against CXCR4 in vitro. Significant mobilization of CD34+ hematopoietic stem cells and CD133+ endothelial progenitor cells was observed when TG-0054 was used alone or combined with G-CSF in preclinical models.
The preclinical and Phase I results support further clinical investigation. The Phase 2 study entitled "A Phase II, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 in Patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease" will begin to enroll patients in December, 2009.
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