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Clinical Trials

Date: 2014-11-07

Type of information: Presentation of results at a congress

phase:

Announcement: presentation of results at the 56th Annual Meeting of the American Society of Hematology (ASH), December 6-9, 2014, in San Francisco, CA.

Company: Erytech (France)

Product: Ery-asp®/Graspa® (eryaspase - L-asparaginase loaded erythrocytes)

Action mechanism:

  • enzyme. Ery-asp®/Graspa® is a new formulation of L-asparaginase encapsulated inside donor-derived red blood cells through Erytech’s proprietary ERYCAPS technology platform. The enzyme degrades asparagine, an amino acid that is essential for the tumor cells to grow and multiply, which starves and eventually kills the cancer cells.

Disease: acute lymphoblastic leukemia (ALL)

Therapeutic area: Cancer - Oncology

Country: France

Trial details:

  • The expanded access program (NCT02197650) was set up to provide access to GRASPA® to patients with acute lymphoblastic leukemia (ALL), in first line or relapse, who are at risk of hypersensitivity reactions due to previous allergies to both the E. Coli and Erwinia derived asparaginases.

Latest news:

  • • On November 7, 2014, Erytech announced the presentation of four case studies with Graspa® in an expanded access program at the 56th Annual Meeting of the American Society of Hematology (ASH), December 6-9, 2014, in San Francisco, CA. The first results of this program indicate reduced hypersensitivity reactions in these ‘double allergic’ patients while maintaining adequate asparaginase activity and they bring additional confirmation of Graspa®’s reduced immunotoxicity, also in patients with prior allergies to E. Coli derived asparaginase, as was recently demonstrated in the top-line Phase III results in relapsed ALL patients. The abstract #937 entitled “L-Asparaginase Allergic Patients Treated with L-Asparaginase Loaded into Red Blood Cells in an Expanded Access Program. Report of Four Cases” will be presented by Prof. Yves Bertrand, Head of the Institute of Pediatric Hemato-Oncology, Lyon, France, as a poster presentation.

Is general: Yes