Apogenix’ experimental protein drug APG101 has achieved its primary target in a mid-stage clinical trial evaluating the agents efficacy as the second line treatment of Glioblastoma Multiforme (GBM), the most common and most aggressive form of brain cancer.

GlioblastomaThe German biotech firm, which span-out of the German Cancer Research Center in 2005, reported the top-line results of the phase II clinical trial for APG101. The trial involved 83 patients from 27 sites in Germany, Austria, and Russia. GBM patients who had first or second relapses and no longer responded to treatment with Temozolomide were randomized with APG101 plus radiotherapy or radiotherapy alone. The primary endpoint of the trial was the six-month-rate of progression-free survival (PFS6) and secondary endpoints include overall survival (OS), safety and tolerability of APG101, plus parameters assessing the patients’ quality of life (QoL).

Apogenix said the primary objective of the trial to increase the percentage of patients PFS6 by 100% was exceeded substantially. No drug-related adverse effects were observed in the trial during treatment with APG101 for up to two years.

Glioblastoma multiforme (GBM) is the most frequent and aggressive malignant brain tumor, accounting for 52% of all functional tissue brain tumor cases and 20% of all intracranial tumors.  GBM is characterized by a high resistance to radio- and chemotherapy and the disease often has a devastating impact on the quality of life and life expectancy of patients. Approximately 28,000 new cases of malignant glioblastomas are diagnosed in the US and EU each year.

Dr Harald Fricke, Chief Medical Officer of Apogenix. said: ‘Current treatment options for GBM are very limited, and the treatment of relapses is predominantly based on experimental approaches. In view of the results of our controlled efficacy study, we are optimistic that APG101 will be of significant patient benefit in this difficult-to-treat disease’

APG101 is a fully human fusion protein consisting of the extracellular domain of the CD95 receptor and the Fc domain of an IgG antibody. The agent works through blocking the CD95–ligand (CD95L) from binding to the CD95-receptor (CD95).

‘The promising data of a combination therapy of APG101 with radiotherapy in relapsed GBM patients leads to the suggestion that a next development step could be the combination therapy of APG101 with standard radio-chemotherapy in newly diagnosed Glioblastoma patients. The main goal should be to significantly improve the standard therapy by adding APG101,’ said Prof Wolfgang Wick,  the principle investigator of the study from German Cancer Research Center and Department of Neuro-Oncology, University Hospital of Heidelberg.

Apogenix said data on secondary endpoints including OS and QoL are expected within the next few months and will be presented at major cancer conferences in the US and Europe later this year.