ERYtech Pharma Announces Second Positive DSMB Review Of Its Phase 2b Study In Acute Myeloid Leukemia
8/27/2014 11:13:27 AM
LYON, France--(BUSINESS WIRE)--Regulatory News:ERYTECH Pharma (Paris:ERYP) (Euronext Paris: FR0011471135 - ERYP), the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, announces that an independent Data and Safety Monitoring Board (DSMB) completed its second safety assessment of the company’s Phase IIb study in Acute Myeloid Leukemia (AML) and unanimously recommended continuation of the trial without modification.
The GRASPA-ML study is a multicentre, randomized, controlled Phase IIb trial evaluating the 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 patient 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 (Recordati Group), ERYTECH’s partner for the commercialization of GRASPA® in 38 European countries.
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