Children's Oncology Group (COG) and Apeiron Biologics AG (Apeiron) will collaborate to evaluate Apeiron's APN301 in a clinical phase II study in pediatric neuroblastoma patients.
APN301, a recombinant fusion protein will be administered along with GM-CSF and isotretinoin to children with refractory or relapsed neuroblastoma.
The study, which is based on a recent trial with an anti-GD2 monoclonal antibody, will commence in Q3, 2011.
Principal investigator and co-chair of the study Paul Sondel said APN301 has demonstrated potent antitumour effects in preclinical trials and has shown clinical antitumour activity in a recently completed clinical phase II trial.
''This next study is designed to provide even greater antitumor activity, to better understand the mechanisms of this activity and identify the characteristics of children most likely to respond," Sondel added.
Apeiron CEO Hans Loibner said the study will provide efficacy data of APN301 in high-risk neuroblastoma patients and the results will provide an important component for the registration of this innovative immunotherapy.