Efficacy trial vs. brain cancer
Apogenix GmbH (Heidelberg) has initiated a Phase II proof-of-concept study with its lead compound AGP101 + radiotherapy (vs radiotherapy alone) in 83 patients with Glioblastoma Multiforme (GBM). The clinical trial, which is expected to run until 2011, is designed as an open-label, randomised, controlled study in patients with first or second relapse of glioblastoma. Primary endpoint of the study is the six-month rate of progression-free survival (PFS6). Secondary endpoints include overall survival, safety and tolerability of APG101, and parameters measuring the quality of life of the patients. PG101 is a human fusion protein combining the extracellular domain of the CD95-receptor and the Fc-portion of IgG1. APG101 is a fusion protein of the extracellular domain of the CD95-receptor and the Fc-portion of IgG1 that blocks CD95-mediated signaling pathways.