APG101 ^[1] is for the treatment of Glioblastoma multiforme (GBM). APG101 is a soluble CD95-Fc fusion protein for the treatment of malignant diseases. APG101 blocks the CD95 ligand (CD95L) from binding to the CD95-receptor (CD95). So far, APG101 has been tested in 20 healthy volunteers and 32 patients. It was well tolerated and has shown no serious side effects.^[2] Currently, APG101's efficacy is being tested in a clinical phase II study with patients suffering from Glioblastoma. The ongoing study was initiated at the beginning of 2010 and is expected to run through 2011. A total of 83 patients will be enrolled in the trial. At the moment, patient recruitment is still ongoing.^[3] APG101 constitutes an innovative approach to treating GBM since it has the therapeutic aim to inhibit the invasive growth of glioblastoma cells. This therapy is based on results from the German Cancer Research Center (DKFZ) that in glioblastoma cells, the binding of the CD95-Ligand to its cognate receptor stimulates the invasive growth of the tumor cells.^[4] Thus, the inhibition of this interaction by APG101 reduces tumor cell migration. An article in Nature ^[5] published on 27 May 2010: CD95 promotes tumor growth supports APG101 s principle of inhibiting the CD95/CD95L system in the treatment of tumors. The paper was submitted by Professor Marcus Peter and his team at the University of Chicago.

Apogenix has been granted orphan drug status for APG101 to treat GBM in Europe and the US.

References

1. ↑ http://apogenix.com/
2. ↑ www.biocentury.com/products/apg101
3. ↑ ClinicalTrials.gov, a service of the U.S. National Institutes of Health, http://clinicaltrials.gov/ct2/show/NCT01071837
4. ↑ Kleber et al: Yes and PI3K bind CD95 to signal invasion of glioblastoma. Cancer Cell, 2008 Mar;13(3):235-48, http://www.ncbi.nlm.nih.gov/pubmed/18328427
5. ↑ www.nature.com/nature/journal/v465/n7297/full/nature09075.html