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Home>ERYTECH Reports Determination of the Recommended Pivotal Phase 3 Dose of eryaspase in its U.S. Phase 1 Study in First Line Adult ALL

ERYTECH Reports Determination of the Recommended Pivotal Phase 3 Dose of eryaspase in its U.S. Phase 1 Study in First Line Adult ALL

ERYTECH Reports Determination of the Recommended Pivotal Phase 3 Dose of eryaspase in its U.S. Phase 1 Study in First Line Adult ALL

09/28/2017

ERYTECH Reports Determination of the Recommended Pivotal Phase 3 Dose of eryaspase in its U.S. Phase 1 Study in First Line Adult ALL

  • Dose of 100 U/kg, which is the same dose used in other studies with eryaspase in adult acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and metastatic pancreatic cancer patients, was recommended for further evaluation of eryaspase in pivotal study in first line adult ALL

Regulatory News:

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today 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 ALL patients.

The U.S. Phase 1 study with eryaspase (GRASPA) is an open label dose escalation study evaluating the safety of eryaspase in combination with CALGB 8811 protocol for first line treatment of adult ALL patients. 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.

ERYTECH recently announced that all patients had 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 AML, 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.

About ERYTECH and eryaspase (GRASPA®): www.erytech.com

Founded in Lyon, France in 2004, ERYTECH is a clinical-stage biopharmaceutical company developing innovative therapies for rare forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate therapeutic drug substances inside red blood cells, ERYTECH has developed a pipeline of product candidates targeting markets with high unmet medical needs. ERYTECH’s initial focus is on the development of products that target the amino acid metabolism of cancer, depriving them of nutrients necessary for their survival.

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