ERYtech Pharma Receives FDA IND Clearance to Initiate a Clinical Study in Acute Lymphoblastic Leukemia in the U.S.
Published: Apr 03, 2013
LYON, France & PHILADELPHIA--(BUSINESS WIRE)--ERYTECH Pharma SA announced today that it has received clearance of its Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) to initiate a Phase I clinical trial of its product ERYASP®, L-asparaginase loaded erythrocytes, in patients 40 years or older with newly diagnosed Acute Lymphoblastic Leukemia (ALL). L-asparaginase has been a mainstay in the treatment of children suffering from ALL, but its use is limited in older and fragile patients due to its toxicity profile. ERYASP® is a new formulation of L-asparaginase, with a safer and broader range of clinical use than existing forms due to the entrapment and protection of the enzyme inside red blood cells. ERYASP® is intended to satisfy the unmet medical needs of older and fragile, patients suffering relapses and other patient groups for whom the current treatments are not suitable. The added value of ERYASP® relates to its ability, as demonstrated in late stage clinical trials in Europe, to overcome existing limitations associated with conventional L-asparaginase via longer efficacy, reduced doses and a better safety profile. This now needs to be confirmed in the U.S.