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Apogenix starts Phase I with its lead compound AGP101


Heidelberg, October 07, 2008 - Apogenix GmbH, a biopharmaceutical company developing novel drugs based on the targeted modulation of apoptosis (programmed cell death), today announced that the Company has started the clinical Phase I trial in healthy volunteers with its lead compound AGP101.

The randomized, double-blind, placebo-controlled study will include 34 subjects and is being conducted in Germany. The first volunteers have been dosed with APG101 in late September 2008, and the substance seems to be well tolerated. The study is designed as a dose escalation trial with seven cohorts of patients who will receive increasing single doses of APG 101. Primary endpoints of the study are safety and tolerability. Results of the Phase I trial are expected in the first half of 2009.

APG101 is a human, soluble fusion protein preventing the CD95 mediated apoptosis of healthy cells. The drug candidate addresses a variety of disease indications which are characterized by an excess of apoptosis, such as acute “Graft-versus-Host Disease” (aGvHD), myocardial infarction, HIV infection, and spinal cord injury. In 2006, Apogenix received orphan drug status for APG101 for the prevention of GvHD by the European Commission.

”We are proud to initiate the first clinical Phase I trial only three years after the operative start of Apogenix GmbH,” said Dr Harald Fricke, Chief Medical Officer of Apogenix. “This step is a major milestone for our team and also for our lead compound APG101, which to our mind has great potential in various indications.”


About Apogenix

Apogenix is a biopharmaceutical company developing novel drugs based on the targeted modulation of apoptosis (programmed cell death).

Apoptosis is a natural and highly controlled mechanism to clear the body of old, damaged or abnormally transformed cells. In many disease indications, this process has become out of balance causing either an uncontrolled removal of healthy cells and tissue (e. g. acute Graft-versus-Host Disease, HIV infection, and spinal cord injury) or a lack of removal of damaged and abnormal cells (e.g. in case of tumors).

Apogenix is a spin-out from the German Cancer Research Center (DKFZ), and is based in Heidelberg, Germany. In 2005, the company has received EUR 15 million in a Series A round from the family of the renowned biotech investor and SAP co-founder Dietmar Hopp and has raised another EUR 28 million in a Series B round in 2008.

About APG101

APG101 is a human, soluble fusion protein combining the extracellular domain of the CD95-receptor and the Fc portion of IgG. CD95, a so-called death-receptor, is triggered by the CD95 ligand to initiate apoptosis. APG101 blocks CD95L-mediated apoptosis by binding to the ligand expressed on effector cells, thereby preventing apoptosis of healthy tissue.

Available research data demonstrates that blockade of CD95L plays an important role in the pathophysiology of diseases characterized by an excess of apoptosis, such as acute “Graft-versus-Host Disease” (aGvHD), myocardial infarction, HIV infection, spinal cord injury, and stroke

Apogenix has been granted orphan drug status for APG101 for the prevention of GvHD 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.

Contact information

Dr Thomas Höger
Apogenix GmbH
Im Neuenheimer Feld 584
D-69120 Heidelberg
Phone: +49 (6221) 5 86 08-0
Fax: +49 (6221) 5 86 08-10
contact@apogenix.com
www.apogenix.com

Ines-Regina Buth
akampion
Platz vor dem Neuen Tor 2
D-10115 Berlin
Phone: + 49 (30) 23 63 27 68
Fax: +49 (30) 23 63 27 69
ines@akampion.com
www.akampion.com


Publisher Contact Information:

Apogenix
+49 (6221) 5 86 08-0
contact@apogenix.com

Company profile of Apogenix
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