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Clinical Trials

Date: 2016-03-24

Type of information: Results

phase: preclinical

Announcement: results

Company: Apogenix (Germany)

Product: APG101 (asunercept)

Action mechanism:

fusion protein. APG101 is a first-in-class, fully human fusion protein combining the extracellular domain of the CD95 receptor and the Fc portion of IgG. The interaction between the CD95 ligand and the CD95 receptor activates an intracellular signaling pathway that stimulates the invasive growth and migration of tumor cells, such as glioblastoma cells. APG101 binds to the CD95 ligand and thus inhibits activation of the CD95 signaling pathway, resulting in reduced tumor cell growth and migration. APG101 was granted orphan drug status for the treatment of glioma (EU/3/09/709) in the EU and for the treatment of glioblastoma and myelodysplastic syndromes in the US.

Disease: myelodysplastic syndromes (MDS)

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

* On March 24, 2016, Apogenix announced that the data published in the current issue of Oncotarget demonstrate that APG101 rescues the production of red blood cells in bone marrow samples from patients with lower-risk myelodysplastic syndromes (MDS). By inhibiting their apoptosis, APG101 increases the number of erythrocyte precursor cells ex vivo and improves their overall proliferation rate. The observational study shows that CD95 is overexpressed in two thirds of patients with lower risk MDS, and that overexpression of CD95 is predictive of a lower response rate to erythropoiesis-stimulating agents. Erythroid response to APG101 could especially be observed in samples from MDS patients with severe impairment of erythropoiesis. Apogenix is currently evaluating the safety, tolerability, and efficacy of APG101 in transfusion-dependent low to intermediate I risk MDS patients. Results are excepted in the coming months.

Is general: Yes