APEIRON Biologics and the Children's Oncology Group have reported a collaboration on conducting a clinical phase II study in neuroblastoma patients. Neuroblastoma, a cancer of the nervous system, can be one of the most difficult to treat childhood cancers with about 650 to 750 children diagnosed each year in the U.S. and the E.U.
In the course of this new clinical trial, Apeiron's APN301, a recombinant fusion protein consisting of the humanized anti-GD2 monoclonal antibody hu14.18 fused to the cytokine interleukin-2 (IL2), will be administered together with GM-CSF and isotretinoin to children with refractory or relapsed neuroblastoma. The design of this trial is based on a recently concluded study with an anti-GD2 monoclonal antibody, performed by COG, in which clinical activity was shown.
The study is scheduled to start in the third quarter of 2011 and will be conducted in multiple hospitals throughout the United States and Canada.