Children's Oncology Group and Apeiron to Jointly Conduct Phase II Study in Neuroblastoma With hu14.18-IL... ( PHILADELPHIA MADISON Wisconsin and VI...)

Children's Oncology Group and Apeiron to Jointly Conduct Phase II Study in Neuroblastoma With hu14.18-IL2 (APN301)

Date:9/29/2011

PHILADELPHIA, MADISON, Wisconsin and VIENNA, September 29, 2011 /PRNewswire/ --

Children's Oncology Group (COG) and APEIRON Biologics AG (Apeiron) announced today that they will jointly investigate Apeiron's APN301 in a clinical phase II study in pediatric neuroblastoma patients.

APEIRON Biologics AG (Apeiron) and the Children's Oncology Group (COG) today announced 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., respectively.

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.

"We are excited to be working with Apeiron to continue to develop this important new approach to treating children with neuroblastoma," said Peter C. Adamson MD, Chair of the Children's Oncology Group. "Being able to leverage immunotherapy is a primary strategic initiative in our efforts to improve the outcome for patients with high-risk neuroblastoma."

Dr. Paul Sondel, Principal Investigator and Study Co-Chair (with Dr. Suzanne Shusterman): "This agent has demonstrated potent antitumor effects in preclinical work and has shown clinical antitumor activity in our recently completed clinical phase II trial. This next study is designed to provide even greater antitumor activity, to bet
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SOURCE APEIRON Biologics AG
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