Date: 2016-06-15
Type of information: Results
phase: 1
Announcement: results
Company: Apogenix (Germany)
Product: Apocept™ (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
Therapeutic area: Cancer - Oncology
Country: USA
Trial details:
Latest
news: * On June 15, 2016, Apogenix announced final topline results from a Phase I trial evaluating APG101 in low to intermediate-1 risk transfusion-dependent patients with myelodysplastic syndromes (MDS). The study showed that APG101 was well tolerated. In addition, the trial showed that APG101 efficiently stimulates erythropoiesis in these patients. * On February 7, 2013, Apogenix has announced the initiation of a clinical Phase I trial with its lead compound Apocept™ in patients with MDS. The clinical trial is designed as an open-label study and is conducted in clinical centers throughout Germany. Recruitment of MDS patients for the study began in January 2013. Endpoints of the study include efficacy (improvement of erythropoiesis), safety, and tolerability parameters. Results of the trial are expected by mid-2014.
The single arm Phase I trial enrolled twenty patients with low to intermediate-1 risk MDS who were transfusion dependent. Patients had to be refractory to erythropoietin-stimulating agents (ESAs). The patients were treated with APG101 over a period of three months and followed for an additional six months. An extension of treatment was not intended. The primary objectives of the study were safety and tolerability. Secondary objectives included changes in transfusion frequency and changes in parameters involved in erythropoiesis.
In the study, treatment with APG101 led to a significant decrease in transfusion frequency for more than six months (end of follow up period) in 44% of the patients. In addition, measurements of parameters involved in erythropoiesis (i.e., number and function of progenitor cells) further supported the activity of APG101 in this patient population. This evidence of in vivo activity of APG101 confirms in vitro data recently published (Oncotarget Vol. 7 No. 12, 2016). More details from the final results of the study are being submitted for presentation at a major medical meeting later this year.
The next step will be to initiate a Phase II trial in MDS to evaluate APG101 in various doses in combination with an erythropoietin-stimulating agent.
