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news.ERYtech Pharma has completed the enrollment and safety follow-up of a Phase II clinical trial for GRASPA.
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The 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 and the trial enrolled 30 patients and involved 54 investigation centers, all being members of the ‘Group for Research on Adult Acute Lymphoblastic Leukemia’ (GRAALL).
GRASPA is a new enzyme formulation of L-asparaginase with a safer and broader range of clinical application compared to existing forms 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 and 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.