Heidelberg, May 12, 2009 - Apogenix GmbH, a biopharmaceutical company
developing novel drugs for malignant and inflammatory diseases, today
reported clinical phase I results on its lead compound AGP101. APG101 is a
protein influencing an important signaling mechanism involved in the onset
and maintenance of these diseases.
The randomized study, which was initiated in September 2008 to explore the
safety and tolerability of APG101, included 34 healthy volunteers. All
endpoints of the double-blind, placebo-controlled, mono-centric study were
met. APG101 was well tolerated and no serious adverse events were
observed. The study was designed as a dose escalation trial with seven
cohorts of patients who received increasing single doses of APG101.
”These results are an important step for the further clinical development of
APG101 in various disease indications,” said Dr Harald Fricke, Chief Medical
Officer of Apogenix. “We have already demonstrated the mode of action of
AP101 as an inhibitor of cell migration, invasive growth, and apoptosis in
preclinical studies, and we are now very much looking forward to
demonstrate the compound´s therapeutic potential in patients."
Apogenix is currently preparing a phase II study with patients suffering from
Glioblastoma, a brain tumor characterized by its highly aggressive invasive
growth. The trial is expected to start in the first half of 2010 and will be
designed as an open-label, controlled study to achieve clinical proof of
concept. Result should be available in 2011. Furthermore, it is planned to
initiate additional phase II trials with APG101 such as for the prevention of
acute “Graft-versus-Host Disease”, an indication for which the European
Commission has granted orphan drug status.
Apogenix is a biopharmaceutical company developing novel drugs based on
the targeted modulation of CD95 and Interleukin-4 receptor mediated
signaling 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.
APG101 is a human, soluble 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 it 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.
Available research data shows that the blockade of CD95L plays an
important role in the pathophysiology of diseases characterized either by an
invasion-prone phenotype such as, e.g. Glioblastoma or by an excess of
apoptosis, such as acute “Graft-versus-Host Disease” (aGvHD) or myocardial
infarction. APG101 has demonstrated a dose-dependent effect in a variety of
animal models of the above mentioned diseases and is in clinical
development for the treatment of Glioblastoma and the prevention of aGvHD.
Apogenix has been granted orphan drug status for APG101 for the
prevention of aGvHD by the European Commission in 2006. The product
candidate is covered by four different patent families claiming the composition
of matter as well as its use for different indications.