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Apogenix myelodysplastic syndrome therapy wins FDA orphan drug designation

PBR Staff Writer Published 08 February 2013

Clinical stage biopharmaceutical company Apogenix's Apocept (APG101) has won FDA orphan drug designation to treat myelodysplastic syndromes (MDS).

Apogenix also announced the commencement of Apocept Phase I trial in MDS patients in Germany.

Endpoints of the open-label study include efficacy (improvement of erythropoiesis), safety, and tolerability parameters and the trial results are expected by mid-2014.

Apogenix COO/CMO Dr. Harald Fricke said Apocept works by restoring the causal impairment of erythropoiesis in MDS.

"After the successful proof of concept in a randomized controlled trial in glioblastoma demonstrating excellent efficacy of Apocept™ both in prolonging progression-free survival as well as overall survival, we are confident that the success story of Apocept™ will continue, with MDS representing the second field of application," Fricke added.

Apocept, which binds to the CD95 ligand and blocks the CD95 receptor activation, was shown to dose-dependently stimulate erythropoiesis in various preclinical studies.

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