Apogenix GmbH announced that the FDA has granted orphan drug designation for Apocept (APG101) for the treatment of myelodysplastic syndromes (MDS). Apocept, a first-in-class, fully human fusion protein combining the extracellular domain of the CD95 receptor and the Fc portion of IgG.  Apocept binds to the CD95 ligand and blocks the activation of the CD95 receptor. Excessive stimulation of the CD95 receptor on hematopoietic cells located in the bone marrow of MDS patients inhibits erythropoiesis. As a result transfusion–dependent anemia develops. Preclinical studies using hematopoietic stem cells from MDS patients show that Apocept dose–dependently stimulates erythropoiesis and thus may help treat anemia.

Apogenix GmbH also announced the initiation of a clinical Phase 1 trial with Apocept in patients with MDS. The study is an open–label trial conducted in clinical centers throughout Germany. Results of the trial are expected by mid–2014.

Apocept had previously been granted orphan drug designation in 2009 for the treatment of glioblastoma in Europe and in the US.

For more information call (212) 845-4292 or visit www.apogenix.com