TaiGen Biotechnology Company, Limited (TaiGen), a leading research-based and product-driven biotechnology company, announced the signing of an agreement to collaborate with Cellex GmbH and the University Hospital Carl Gustav Carus Dresden in Germany in an investigator-initiated clinical trial using burixafor in stem cell mobilization in healthy donors.
The study titled “Burixafor in allogeneic poor mobilizers” is a phase 2 open-label study to determine the effect of a single dose of burixafor in up to 37 poor mobilizers. The rate of donation success will be measured as the primary endpoint.
Under the terms of the agreement, Cellex will be responsible for obtaining clinical trial approval and conduct of the trial and assume all associated costs. TaiGen will have the option to obtain and use the data for future development and filing of market authorization.
Professor Gerhard Ehninger, founder of Cellex and Chair of the Department of Hematology at the University Hospital commented, “We learned of burixafor at the 2013 American Society of Hematology meeting and were impressed with its efficacy in autologous transplantation. Currently approximately 5% of allogeneic donors fail to mobilize enough CD34+ cells to reach an optimal dose for transplantation using G-CSF. Patients receiving transplants with suboptimal CD34+ doses are at risk for delayed or incomplete engraftment and increased rate of infections. The stem cell mobilization activity of burixafor will be highly desirable in increasing CD34+ cell yields in poor mobilizing donors.”
Dr Ming-Chu Hsu, chairman and CEO of TaiGen said, “We are delighted to work with Professor Ehninger, an experienced hematologist and key opinion leader. From our clinical study to date, we know that burixafor has excellent activity and safety in healthy volunteers and cancer patients. With Cellex as our partner we have access to a larger donor population and study its effect on donors who failed G-CSF. This collaboration with Professor Ehninger and Cellex enabled TaiGen to explore additional indications and increase the market potential of TG-0054.”
Cellex, founded by Professor Ehninger in 2001, is the largest stem cell collection center in Germany and one of the largest in Europe. The two sites of Cellex in Dresden and Cologne together performed over 3,000 stem cell collections in 2014 and are serving donors and patients worldwide.
Burixafor, also known as TG-0054, is a novel, potent and selective chemokine receptor antagonist discovered by TaiGen. Burixafor rapidly mobilizes stem cells and progenitor cells from the bone marrow into peripheral circulation. Burixafor is currently in Phase 2 study in autologous stem cell transplantation in the US. Another Phase 2 study in chemosensitization is planned for China in 2015. Other potential indications also include regenerative medicine and ischemic diseases.
TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to TG-0054, TaiGen has two other NCEs in product portfolio: Nemonoxacin (oral formulation) has received NDA approval from Taiwan FDA and pending approval from China FDA; and TG-2349 is a pan-genotypic NS3/4A protease inhibitor currently in phase 2.