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7 Feb 2013

Apogenix Strengthens Patent Position for Apocept (APG101) in Europe and Canada

Apogenix GmbH, a clinical stage biopharmaceutical company developing novel protein therapeutics for the treatment of cancer and inflammatory diseases, announced today that it was able to expand the patent protection for its lead product candidate Apocept (APG101). The company was recently granted two patents that cover the medical use of Apocept (APG101) in Europe and Canada. The European patent protects the medical use of CD95 inhibitors and CD95 ligand inhibitors, such as Apocept (APG101), for the treatment of glioblastoma. This patent is valid until 2027. The Canadian patent covers the use of CD95 ligand inhibitors for the treatment of neurological disorders and expires in 2024. Additional patent applications in the US and other key markets are pending.

"Apogenix has now a very extensive patent portfolio that provides broad coverage for the use of CD95 inhibitors and CD95 ligand inhibitors in the treatment of brain tumours. Expanding the patent protection is an important element in harnessing the medical and economic potential of this innovative therapeutic approach," Dr Thomas Hoeger, CEO/CFO of Apogenix, stated. 

Apocept (APG101) is a fully human fusion protein that consists of the extracellular domain of the CD95 receptor and the Fc portion of an IgG antibody. The interaction between the CD95 ligand and the CD95 receptor activates an intracellular signaling pathway that stimulates the invasive growth and migration of tumour cells, such as glioblastoma cells. Apocept (APG101) binds to the CD95 ligand and thus inhibits activation of the CD95 signaling pathway, resulting in reduced tumor cell growth and migration. Similar effects have been observed in other solid tumours, such as liver, ovarian, and pancreatic cancer. This underlines Apocept's (APG101) therapeutic potential in other indications in which inhibition of the CD95 ligand plays an important role.

A controlled Phase II proof of concept study with Apocept (APG101) in patients with recurrent glioblastoma multiforme (GBM) has met and exceeded its primary endpoint in March 2012. The primary endpoint was to double the number of patients reaching progression-free survival at six months (PFS6). A number of important secondary endpoints were also met in 2012. In January 2013, Apogenix initiated a clinical Phase I trial with Apocept (APG101) to treat patients with myelodysplastic syndromes (MDS).

Apocept (APG101) is currently protected by nine patent families covering both the composition of matter, as well as the use of the substance in various indications. In addition, Apocept (APG101) was granted orphan drug status in the EU for the treatment of glioma and in the US for the treatment of GBM and MDS.

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