Clinical Trials

Date: 2017-09-28

Type of information: update on patient enrollment

phase: 1

Announcement: update

Company: Erytech Pharma (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: USA

Trial details:

• Erytech’s first clinical study with ERY-ASP in the United States is a Phase I dose escalation study in newly diagnosed ALL patients over 40 years of age. The study foresees a safety review after each cohort of patients treated and requires FDA approval for moving to the next dose. The study is performed at five clinical sites across the United States. Prof. Dr. Richard Larson, director of the Hematologic Malignancies Clinical Research Program at the University of Chicago, is the principal investigator of the study. (NCT01910428)

Latest news:

• • On September 28, 2017, Erytech announced the determination of the recommended pivotal Phase 3 dosing from its U.S. Phase 1 dose escalation study with eryaspase (Graspa®) in first line treatment of adult acute lymphoblastic leukemia (ALL) patients. All patients have been treated in the third dose escalation cohort of this Phase 1 study. The steering committee of the study reviewed the safety data of all three treatment cohorts and agreed to pursue further development at the dose level of 100 U/kg.
• This dose level had been previously recommended following Erytech’s Phase 2 study in elderly ALL patients. It is also the dose level used in the Phase 2b study in second line, metastatic pancreatic cancer, that recently reported positive efficacy and safety results, and in the ongoing Phase 2b study in acute myeloid leukemia, from which top-line results are expected by the end of this year.
• In parallel with running an expansion cohort of this Phase 1 study at this recommended dose, Erytech will potentially initiate the steps toward the launch of a pivotal Phase 3 study in first line adult ALL patients at this dose level.
• • On June 22, 2015, Erytech Pharma announced positive safety reviews after the completion of the first cohort in the company’s US Phase I study with ERY-ASP in acute lymphoblastic leukemia. The safety data of the first cohort of patients (at dose 50 IU/kg) has now been reviewed by a steering committee (SC) consisting of the DSMB members and investigators in the study. No safety concerns have been identified and the SC recommends escalating ERY-ASP dose to the next dose level of 100 IU/kg. There is a strong commitment from the investigators on the study to complete the trial in a speedy manner.
• • On July 22, 2014, Erytech Pharma announced the enrollment of the first patient in its Phase I/II study with ERY-ASP in acute lymphoblastic leukemia in the US. In Europe, ERY-ASP is in a Phase III clinical trial in relapsing acute lymphoblastic leukemia, in Phase IIb in acute myeloid leukemia and in Phase II in pancreas cancer. In the US, the safety profile of ERY-ASP is being confirmed in a dose escalating Phase I/II study in 12 to 18 ALL patients. The study has been authorized by the FDA in 2013 and three centers are currently open for patient recruitment: The University of Chicago, Duke University Medical Center and Ohio State University. Professor Larson, Director of the Hematological Malignancies Clinical Research Program at the University of Chicago is the principal investigator of the study. The first patient has been enrolled and treated last week in Columbus, Ohio. The investigational product has been produced at Erytech’s manufacturing facility in Philadelphia. Thanks to a manufacturing agreement with the American Red Cross, this facility is fully operational at GMP level for the production of clinical batches.
• • On April 3, 2013, Erytech Pharma  has announced that it has received clearance of its Investigational New Drug (IND) Application from the FDA to initiate a Phase I clinical trial of its product Eryasp®, L-asparaginase loaded erythrocytes (Graspa® in the EU), in patients 40 years or older with newly diagnosed Acute Lymphoblastic Leukemia (ALL). L-asparaginase has been a mainstay in the treatment of children suffering from ALL, but its use is limited in older and fragile patients due to its toxicity profile. Eryasp® is a new formulation of L-asparaginase, with a safer and broader range of clinical use than existing forms due to the entrapment and protection of the enzyme inside red blood cells. The added value of Eryasp® relates to its ability, as demonstrated in late stage clinical trials in Europe, to overcome existing limitations associated with conventional L-asparaginase via longer efficacy, reduced doses and a better safety profile. This now needs to be confirmed in the U.S.  The company plans to start enrollment of ALL patients in the Phase I study in H2 2013. In collaboration with the American Red Cross in Philadelphia, Erytech has secured a fully operational manufacturing facility where Eryasp® will be manufactured for the clinical trials. The product holds orphan drug designation in Europe and the US. Prof Richard A. Larson, Director of the Hematological Malignancies Clinical Research Program at the University of Chicago and former Chairman of the Leukemia Committee of the Cancer and Leukemia Group B (CALGB) will be the principal investigator of the study and four additional academic medical centers will be participating.

Is general: Yes