TaiGen Biotechnology signs collaboration with stem cell collection center Cellex

Taiwan-based drug developer TaiGen Biotechnology has signed an agreement 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 is a Phase II open-label trial 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, the largest stem cell collection center in Germany and one of the largest in Europe, 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.

Gerhard Ehninger, founder of Cellex and chairman of the Department of Hematology at the University Hospital, said: “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.”