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Stem cell mobilizer: Burixafor


Burixafor

Burixafor is a potent and selective CXCR4 chemokine receptor antagonist discovered and developed by TaiGen. Burixafor rapidly mobilizes stem cells and progenitor cells from the bone marrow into peripheral circulation. Potential indications include:

Stem cell transplantation – increasing the yield of stem cells harvested for transplantation and reducing side effects

Hematological cancer chemosensitization – for mobilizing malignant cells hidden in the bone marrow and render them to killing by chemotherapeutic agents

Treatment in myocardial infarction – for mobilizing endothelial progenitor cells to restore heart function and reducing necrotic heart muscle tissue

A Phase I trial in healthy volunteers and a Phase II POC trial in autologous hematopoietic stem cell transplantation were completed under IND with the US FDA. Responses from the multiple myeloma patients indicate that burixafor alone is sufficient to mobilize sufficient stem cells for transplantation without the need to use granulocyte-colony stimulating factor (G-CSF), the current standard-of-care. Mobilization with G-CSF is a lengthy and costly procedure and may cause significant side-effects such as bone pain. These encouraging results were presented at the 2013 American Society of Hematology Annual Meeting in New Orleans, USA.


Burixafor also mobilizes hematological cancer cells residing in the bone marrow that are inaccessible to chemotherapeutic agents, which is a major cause for disease recurrence. Treatment with Burixafor prior to chemotherapy could mobilize these malignant cells in the bone marrow and render them to killing by chemotherapeutic agents eliminating residual diseases and extending survival time. TaiGen have initiated chemosensitization studies in AML (acute myeloidc leukemia) patients in China.


In addition to oncology indications, TaiGen and its collaborator have shown Burixafor’s utility in ischemic diseases in pre-clinical studies. In a mouse ischemic limb model, TaiGen have demonstrated that Burixafor’s could effectively enhance blood flow, increase blood vessel formation and improve limb functions. Furthermore, in two different animal models of myocardial infarction, Burixafor greatly reduced the infarct size, and also increased the ventricular ejection volume. Based on these results, burixafor could offer a novel and effective treatment for ischemic diseases.


Intellectual Property

Burixafor is protected globally by a portfolio of patents that cover composition of matter, use and manufacturing process up to 2029.

Awards and Grants

Awarded the 2008 National Innovation Award, Corporate R&D Class, from Taiwan's Institute for Biotechnology and Medicine Industry.

Awarded the 2008 Chinese Chemical Society, Medal of Technology.

Received grants from the Taiwan Ministry of Economic Affairs for preclinical, Phase 1 and clinical development.


Business Development

Available for partnerships for territories outside of Greater China.


Presentations

2009 ASH

TG-0054, a Novel and Potent Stem Cell Mobilizer, Displays Excellent PK/PD and Safety Profile in Phase I Trial David T Chung, Li-Wen Chang, Ying-Huey Huang, Cheng-Yuan Tsai, Ching-Hung Hsu, Chi-Hsin R. King, Judy H. Yuan, Chi-Feng Yen, Yu-Mai Chen, Yi Chin Lu and Ming-Chu Hsu

Rapid Mobilization of Murine Hematopoietic Stem and Progenitor Cells with TG-0054, a Novel CXCR4 Antagonist Ying-Huey Huang, Yi-Chun Liu, Chi-Feng Yen, Hua-Chien Chen, Shu-Jen Chen, Chi-Hsin R. King, and Ming-Chu Hsu


2013 ASH

Rapid Mobilization Of CD34+ Progenitor Cells With TG0054-03, a novelCXC Chemokine Receptor 4 (CXCR4) Antagonist Michael W. Schuster, Nabil Hagog, Bita Jalilizeinali, Sharon Funkhauser, Mary Sophy Yohannan, Jennifer Sadler, Sylvia Wood, Stacy Carey, Karen Kelleher, Chen-En Tsai, Ming-Chu Hsu, Li-Weng Chang and Zora Hsu


2015 ASH

A Phase II, Open-Label Pilot Study to Evaluate the Hematopoietic Stem Cell Mobilization of TG-0054 Combined with G-CSF in 12 Patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Lymphoma - an Interim Analysis Gayatri Setia , Nabil Hagog , Bita Jalilizeinali, Sharon Funkhouser, Loretta Pierzchanowski, Fengshuo Lan, Theodore G. Gabig, Bonnie Kiner-Strachan, Karen Kelleher , Ming-Chu Hsu, Li-Wen Chang and Michael W. Schuster.