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
Apogenix is a biopharmaceutical company developing novel drugs based on the targeted modulation of CD95 and Interleukin-4-receptor mediated signalling pathways. These pathways play an important role in a variety of malignant and inflammatory diseases.
Apogenix is a spin-out from the German Cancer Research Center (DKFZ), and is based in Heidelberg, Germany. Since 2005, the company has raised EUR 43 million in two financing rounds, mainly from the family of the renowned biotech investor and SAP co-founder Dietmar Hopp.
About APG101
APG101 is a human fusion protein combining the extracellular domain of the CD95-receptor and the Fc-portion of IgG1. CD95 is a receptor with pleiotropic functions transmitting apoptotic and non-apoptotic signals such as migration and invasion of tumor cells, and is triggered by the CD95 ligand (CD95L). APG101 blocks CD95-mediated signaling pathways by binding to the ligand, thereby blocking activation of the CD95 system.
Apogenix has been granted orphan drug status for APG101 in Glioblastoma Multiforme (GBM) in Europe and the U.S and for the prevention of aGvHD in Europe. The product candidate is covered by four different patent families claiming the composition of matter as well as its use for different indications.
