French biopharmaceutical company, ERYTECH Pharma has received authorizations for its phase IIb GRASPA-ML clinical trial in Acute Myeloid Leukaemia (AML) in Finland and Spain.

The study was first launched in France in March 2013, where to-date more than one third of the patients (out of a total of 123 patients to be recruited to complete the study) have been enrolled. The opening of centers in additional countries is adding international credibility and visibility to the study and is expected to further accelerate the pace of patient recruitment. Next to France, Spain and Finland, additional countries are expected to be authorized in the coming months.

The GRASPA-ML study is a multicentre, 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 November 2013, an independent Data and Safety Monitoring Board (DSMB) completed its first assessment of the study and unanimously recommended continuation of the trial as planned.

The study is performed in collaboration with Orphan Europe (Recordati Group), ERYTECH’s partner for the commercialization of GRASPA in 38 pays European countries, under a licensing and distribution agreement that was signed at the end of 2012.

“We are pleased with the good progress of our phase IIb study in Acute Myeloid Leukaemia. Patient enrollment is in line with our expectations and the opening of foreign centres will further strengthen the study. If positive, the study will broaden the scope of use of our GRASPA product to AML, the most common type of acute leukemia in adults,” comments Yann Godfrin, co-founder and CSO of ERYTECH.