ERYtech Pharma announces the early completion of the enrollment and safety follow-up a Phase II clinical trial for GRASPA®. This open-labeled trial (GRASPALL-GRAALL SA2 2008) introduced GRASPA® in a first-line treatment for Acute Lymphoblastic Leukemia (ALL) in patients older than 55 years. The clinical end point combines safety and efficacy parameters. The trial enrolled 30 patients and involved 54 investigation centers, all being members of the "Group for Research on Adult Acute Lymphoblastic Leukemia" (GRAALL). The company expects to have safety and efficacy data from this study in the third quarter of 2011.
Prof Mathilde Hunault-Berger, Onco-Hematologist at the University Hospital of Angers (France), member of the GRAALL cooperative group and principal investigator for the study: "The enrollment for this clinical trial was very efficient. I want to take the opportunity to thank all the investigators and their staff for their intensive collaboration. With this important achievement, we really hope this new L Asparaginase form will open a safer way to treat acute lymphoblastic leukemia in adults and patients older than 55 years."
"It was very exciting to work with highly motivated investigators. During the study, they all appreciated that we could successfully and easily manage and control the logistics of the product. We are pleased that we have reached this crucial milestone in the clinical development of GRASPA®" added Dr Yann Godfrin, Co-Founder, Executive Vice President - Preclinical & Clinical Research of ERYtech Pharma.
GRASPA® is a new enzyme formulation of L-asparaginase with a safer and broader range of clinical application compared to existing forms thanks to the entrapment of the enzymes and protection inside homologous red blood cells. GRASPA®'s (encapsulated L-asparaginase in red blood cells) interest is to overcome the existing limitations associated with conventional L-asparaginase treatment through a longer lasting efficacy, better compliance, reduced dosage and an improved safety profile; making it suitable for every ALL patient, including the high risk group (hypersensitive, elderly patients).
L-asparaginase is a vital component of combination chemotherapy for ALL. The enzyme depletes the plasmatic amino acid asparagine, which leukaemia cells require to continue their rapid, malignant growth. Infusion of L-asparaginase destroys the external source of asparagine, which starves leukaemia cells of this amino acid and leads to cellular death.
Source: ERYtech Pharma