On August 29, 2016 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), the French biopharmaceutical company developing ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, reported that it has reached full patient enrollment in the Phase 2b trial of eryaspase, also known as ERY-ASP or GRASPA, for the treatment of acute myeloid leukemia (AML) (Press release, ERYtech Pharma, AUG 29, 2016, View Source [SID:1234514790]). Schedule your 30 min Free 1stOncology Demo! The open-label, randomized, multi-center clinical trial, which is being conducted at more than 20 sites in Europe, has completed enrollment of a total of 123 patients and is on track for reporting of primary data in the second half of 2017. Patients enrolled in the trial are over the age of 65, newly-diagnosed with AML, and unable to receive intensive chemotherapy. The primary endpoint is overall survival (OS) at one year.
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"We are pleased to have reached this important clinical milestone of complete enrollment in our trial for AML and expect to reporting primary data from the trial in the second half of 2017," said Gil Beyen, Chairman and CEO of ERYTECH. "AML is a very aggressive cancer. We are developing eryaspase with the goal of contributing to the treatment of these patients, many of whom may respond to L-asparaginase, but have difficulty with the side effects associated with the current available forms. Therefore, we believe the increased tolerability profile obtained through the encapsulation of L-asparaginase in the red blood cells could result in a new innovative approach to treatment of AML patients."
Eryaspase, or GRASPA, consists of the L-asparaginase enzyme 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. The Phase 2b trial was designed to evaluate the efficacy of GRASPA when added to low-dose cytarabine, the current standard of care. The study is performed in collaboration with Orphan Europe (Recordati Group), ERYTECH’s partner for the anticipated commercialization of GRASPA for the treatment of ALL and AML in Europe.
About acute myeloid leukemia (AML)
With about 34 000 new patients per year in Europe and the US, AML is the most common type of acute leukemia. Affecting mainly the adult and senior patient population that often cannot tolerate the existing forms of asparaginase products, AML represents one of the highest mortality rates among all type of cancers and an important unmet medical need.