Heidelberg, January 11, 2010 - Apogenix GmbH, a biopharmaceutical company today announced the start of a clinical Phase II trial with its lead compound AGP101 in Glioblastoma Multiforme (GBM). The first patient has been treated with APG101 since December 2009 at the University Hospital in Heidelberg, Germany. The clinical trial is designed as an open-label, randomized, controlled study in patients with first or second relapse of Glioblastoma. The trial will include up to 83 patients and up to 20 study centers across Europe. Patients will receive APG101 plus radiotherapy versus radiotherapy alone. Primary endpoint of the study is the 6-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. ”By blocking the invasive growth of Glioblastoma Multiforme, APG101 addresses the key malignant process determining the prognosis of the patients. With APG101 we hope to fundamentally improve the therapeutic armamentarium for the treatment of GBM,” said Dr Harald Fricke, Chief Medical Officer of Apogenix. “The goal of the current Phase II study is to achieve clinical proof-of-concept for APG101 in 2011.” The principle investigator of the study, Prof Wolfgang Wick (Clinical Cooperation Unit Neurooncology German Cancer Research Center and Department of Neurooncology University Hospital of Heidelberg) stated: “We are very satisfied with the rapid clinical translation of this new and innovative therapeutic option for patients with Glioblastoma. The collaboration between the involved parties (Apogenix, German Cancer Research Center and National Center for Tumor Diseases, NCT) is an example for the effective translation of basic scientific knowledge into clinical application.” In addition to the ongoing study, Apogenix plans to initiate further Phase II trials with APG101, e.g. for the prevention of acute “Graft-versus-Host Disease”. About Apogenix
