Acute Myeloid Leukemia
|Product Candidate / Program||Drug substance||Indication||Discovery||Pre-clinical||Phase I||Phase II||Phase III / Pivotal||EMA/FDA REVIEW|
|eryaspase (GRASPA® in Europe and Israel)||Asparaginase||AML||EU then EU/US|
Acute Myeloid Leukemia (AML) is an aggressive cancer of the blood and bone marrow that is particularly fatal if left untreated. AML patients have an outgrowth of cells from the myeloid lineage that accumulate in the bone marrow. The myeloid cells are predominantly immature platelet cells called myeloblasts, or blasts, which are the leukemia cells. Bone marrow cell dysfunction is caused by genetic mutations that impact the normal differentiation of stem cells.
We are also developing eryaspase for the treatment for AML patients, many of whom may respond to L-asparaginase but cannot be treated with it due to its side effects.
We initiated a Phase 2b, open-label, randomized, multi-center clinical trial in newly diagnosed patients with AML over 65 years of age and who are unable to receive intensive chemotherapy. The primary objective of this trial is to evaluate the efficacy of eryaspase under the trade name GRASPA when added to a low dose of the standard chemotherapy cytarabine.
We have completed enrollment of 123 patients in the trial at over 20 sites in Europe. Results are expected Q4 2017.