Positive results from ERYTECH Pharma asparaginase Phase II trials on ALL

ERYTECH PharmaJun 18 2012

The oral presentation will be held on June 17^th 2012 by Prof. Dr. Hervé Dombret, Hospital Saint Louis, Paris (France) at the 17th Annual Meeting of European Hematology Association (EHA) in Amsterdam (The Netherlands).    

Thirty patients over 55-years old, newly diagnosed with Acute Lymphoblastic leukemia (ALL) were included in this Phase II trial. The patients received different doses of erythrocyte encapsulated Asparaginase in combination with the chemotherapy recommended by the European Working group for Adult Lymphoblastic Leukemia (EWALL). Asparaginase is a major and mainstay drug to treat ALL, but current formulations are not recommended in induction therapy for these older patients who are particularly frail for toxicity reasons.

Erythrocyte encapsulated Asparaginase introduced in first line induction therapy showed a good safety profile even in the elderly patients and is efficient for asparagine depletion. At the optimal dose (100IU/Kg), 91% of the patients at the end of induction therapy reached a complete remission and the median overall survival was 15.6 months. The enrollment of the patients was finished 2 months in anticipation to the expectations. The study was performed in close collaboration to the cooperative group GRAALL (Group for Research in Adult Acute Lymphoblastic Leukemia).

"I would like to thank the investigators of the GRAALL for their collaboration in setting up and conducting this important clinical trial. The results demonstrate that our asparaginase formulation offers the possibility to safely administrate this very useful drug in fragile older ALL patients for which today no alternative exist." says Dr Yann Godfrin, Executive Vice President Preclinical and Clinical Reseach.