DSMB backs continuation of Erytech's Ph IIb study of Graspa

French cancer focused drug developer Erytech Pharma (Paris: ERYP) says that an independent Data and Safety Monitoring Board (DSMB) completed its first assessment of the company’s Phase IIb study of Graspa, human erythrocytes encapsulating L-asparaginase, for the treatment of hematological malignancies, in acute myeloid leukemia (AML) study and unanimously recommended continuation of the trial without modification.

The GRASPA-ML study is a multicenter, randomized, controlled Phase IIb trial evaluating efficacy and tolerability of Graspa in the treatment of newly diagnosed AML patients over 65 years old that are unfit for intensive chemotherapy. In this 123 patients study, one-third of the patients receive the current standard treatment (low-dose cytarabine) and two-thirds receive low-dose cytarabine plus Graspa. The study was initiated in March 2013 and is performed in collaboration with Orphan Europe (Italy’s Recordati Group; RC: MI), Erytech’s partner for the commercialization of Graspa in 38 European countries (The Pharma Letter November 25, 2012).

The DSMB assessment was based on a pre-planned safety analysis on the first 30 patients included in the study and with a minimum of 1 month follow-up. A second DSMB review is planned when 60 patients will be treated in the study.