ERYtech Pharma Starts Its Pivotal Clinical Trial For GRASPA(R) In Acute Lymphoblastic Leukaemia

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials;  Blood / Hematology;  Cancer / Oncology
Article Date: 06 Nov 2009 - 21:00 PST

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ERYtech Pharma announces the start of its pivotal clinical trial for GRASPA®, its lead product in Acute Lymphoblastic Leukaemia. This phase III trial has begun in France and will be enlarged to a European scale. Up to 80 patients with relapsed Acute Lymphoblastic Leukaemia, aged from 1 to 55 years old will be enrolled. The endpoint combines safety and efficacy with regard to the asparagine depletion level.

Professor Yves Bertrand, Head of Paediatric Onco-hematology in Lyon and main investigator says, "I would be really content to see confirmation of the very encouraging phase II trial with GRASPA®. We designed this trial to fit with the medical needs."

GRASPA® is a new enzyme formulation of L-asparaginase with a safer and broader range of clinical uses, compared to existing forms, due to the entrapment and protection of the enzyme inside the homologous red blood cell. GRASPA®'s (encapsulating L-asparaginase in red blood cells) interest lies in overcoming all existing limitations associated with conventional L-asparaginase through longer efficacy, better compliance, reduced dosage and an increased safety profile; making it satisfactory for every ALL patients, even high risk ones (hypersensitive, elderly patients), or patients with neutralising antibodies.

L-asparaginase is a critical and irreplaceable component of combination chemotherapy for ALL and has been used in the clinic for over 30 years. The enzyme depletes the plasmatic amino acid asparagine, which leukaemia cells require to continue their rapid, malignant growth. While normal cells are able to make a sufficient amount of asparagine internally, leukaemia cells cannot. Infusion of L-asparaginase destroys the external source of asparagine, which starves leukaemia cells of this amino acid and leads to cellular death.

Doctor Yann Godfrin, Co-Founder and CEO of ERYtech Pharma claims: ''I am very proud to say that this study is the result of a strong collaboration between the physicians, the experts of the EMEA and our clinical development team. This trial is a great opportunity for the physicians of several European countries to use GRASPA®. It is so exciting while the 5-year old birthday of the company to start a pivotal study with the target of gaining market authorization''.

Source
ERYtech Pharma