VIACELL ENDS CORD BLOOD TRANSPLANT STUDY

ViaCell announced results of its Phase I clinical trial evaluating its investigational umbilical cord blood transplant therapy, CB001, for treating patients with advanced hematologic cancers. Transplantation with CB001 was generally well tolerated.

Data on clinical measures of engraftment in the trial were comparable to transplantation outcomes reported in published literature from standard transplants using blood from two umbilical cords. While the presence of CB001 was detected in some patients at earlier time points, chimerism from CB001 was not detected at 21 to 28 days post transplant. Chimerism, the presence of donor cells, is, by day 21 to 28, an indication of the potential ability of a transplant source to reconstitute a patient. Given these results and the shift in the treatment paradigm in transplant medicine from single-cord to two-cord transplants, ViaCell has made the decision not to advance CB001 in future clinical trials.

"We are encouraged by the safety profile of CB001. Nonetheless, given the lack of chimeric contribution and because the results are consistent with the current clinical evolution of two-cord transplants, we made the decision not to advance CB001 to a Phase II trial," Marc Beer, president and CEO of ViaCell, said.

CB001 is composed of stem cells isolated from umbilical cord blood and expanded using ViaCell's proprietary expansion technology. The Phase I clinical trial was primarily designed to evaluate safety in patients with advanced hematologic cancers in need of a hematopoietic stem cell transplant and who were unable to find a suitable bone marrow donor. Patients requiring this type of therapy typically have few therapeutic options, according to the company. Patients participating in the study received CB001 plus a standard cord blood unit following full myeloablative therapy.