|ERYTECH Reports Determination of the Recommended Pivotal Phase 3 Dose of eryaspase in its U.S. Phase 1 Study in First Line Adult ALL|
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
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.
The company’s lead product, eryaspase, also known under the trade name GRASPA®, consists of an enzyme, L-asparaginase, encapsulated inside donor-derived red blood cells. L-asparaginase depletes asparagine, a naturally occurring amino acid essential for the survival and proliferation of cancer cells. L-asparaginase has been a standard component of multi-agent chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), but side effects limit treatment, especially in adults and patients with weak performance status. With its improved safety profile, eryaspase aims to provide L-asparaginase to patients who cannot tolerate current non-encapsulated asparaginases.
Eryaspase achieved positive efficacy and safety results in a Phase 2
study in elderly patients with ALL, and a Phase 2/3 study in children
and adults with relapsed or refractory ALL. ERYTECH believes that the
positive results of its Phase 2b clinical study in second-line
metastatic pancreatic cancer are significant indicators of eryaspase as
a potential treatment approach in solid tumors. ERYTECH also has an
ongoing Phase 1 clinical study of eryaspase in
ERYTECH produces eryaspase at its own GMP-approved and operational
manufacturing site in
In addition to eryaspase, ERYTECH is developing two other product candidates, erymethionase and eryminase, that focus on using encapsulated enzymes to target cancer metabolism and induce tumor starvation. ERYTECH is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies (ERYMMUNE) and enzyme replacement therapies (ERYZYME).
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