APG101

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APG101 is an active ingredient used to treat glioblastoma multiforme (GBM).

description

APG101 is a soluble fully human CD95-Fc fusion protein for the treatment of malignancies. APG101 consists of the extracellular domain of the CD95 receptor and the Fc part of the IgG antibody . APG101 prevents the binding of the CD95 ligand (CD95L) to the CD95 receptor (CD95). So far, APG101 has been tested on 20 healthy volunteers and 32 patients; it showed good tolerability with no serious side effects.

The efficacy of APG101 was evaluated in a phase II randomized clinical trial in patients with glioblastoma who had relapse. The treatment consisted either of re-irradiation of the tumor region alone or of re-irradiation with the additional administration of APG101. Recruitment for the study began in early 2010 and in February 2012 the last patient in the study had been followed up for 6 months. A total of 83 patients were treated as part of the clinical trial. According to a press release dated March 8, 2012 by apogenix, the primary endpoint of the study, a doubling of progression-free survival after 6 months, was significantly exceeded. Other secondary endpoints such as overall survival or quality of life data will be reported.

APG101 is an approach to the treatment of glioblastoma insofar as the therapeutic goal is to prevent the invasive growth of glioblastoma cells. This therapy is based on findings from the German Cancer Research Center and the Heidelberg University Hospital , according to which the binding of the CD95 ligand to the CD95 receptor in glioblastoma cells stimulates the invasive growth of tumor cells. A blockage of this binding by APG101 therefore leads to the prevention of the invasive growth of these cells.

The article “CD95 promotes tumor growth” published on May 27, 2010 in the magazine “Nature” supports the principle of blocking the C95 / CD95L system in the treatment of tumors used in APG101. The essay was submitted by Marcus Peter at the University of Chicago.

APG101 was granted orphan drug status in Europe and the USA in 2009 .

Individual evidence

  1. ↑ APG101 product page at Apogenix ( Memento from January 8, 2015 in the Internet Archive )
  2. ↑ Press release of March 8, 2012 from apogenix about the achievement of the goal of the APG101 study in recurrent glioblastoma ( Memento from December 25, 2014 in the Internet Archive ) (PDF; 63 kB)
  3. ↑ Clinical study (phase II): APG101 in glioblastoma at Clinicaltrials.gov of the NIH .
  4. ↑ Kleber S, Sancho-Martinez I, Wiestler B, et al. : Yes and PI3K bind CD95 to signal invasion of glioblastoma . In: Cancer Cell . 13, No. 3, March 2008, pp. 235-48. doi : 10.1016 / j.ccr.2008.02.003 . PMID 18328427 .
  5. ↑ Chen L, Park SM, Tumanov AV, et al. : CD95 promotes tumor growth . In: Nature . 465, No. 7297, May 2010, pp. 492-6. doi : 10.1038 / nature09075 . PMID 20505730 . PMC 2879093 (free full text).