14 September 2015 - Erytech Pharma, the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, announces today the submission of a centralized Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for ERY-ASP (Invented Name: Graspa) for the treatment of patients with acute lymphoblastic leukemia (ALL).

The MAA for Graspa, Erytech’s lead product, consisting of asparaginase encapsulated in red blood cells, is based on the positive findings of the pivotal GRASPALL 2009-06 Phase 2/3 study in children and adults with relapsed ALL.

In the GRASPALL Phase 2/3 study, the results of which were reported in December 2014, Graspa in combination with chemotherapy was observed to result in improved clinical activity and tolerability as compared to native L-asparaginase in patients with relapsed ALL. The mean duration of asparaginase activity above 100 IU/L was 20.5 days in the Graspa group versus 9.6 days in the control arm of patients treated with native L-asparaginase in combination with chemotherapy (p<0.001), and patients in the study treated with Graspa also demonstrated a significantly lower incidence of hypersensitivity reactions as compared to those in the control arm (p<0.001). Patients treated with Graspa also experienced an improvement in complete remission (CR) rate (p=0.024) as compared to those in the control arm. Treatment with Graspa was generally well tolerated, and those treated with Graspa also had a lower incidence of adverse events, such as coagulation disorders, pancreatic toxicities and hepatic toxicities, than those treated with native L-asparaginase.

Gil Beyen, CEO and Chairman of Erytech Pharma, commented: “I am delighted that we have submitted this application to the EMA. It represents an important achievement in the company’s efforts to bring a meaningful therapeutic option to patients and families with acute lymphoblastic leukemia and a significant milestone in Erytech’s development.”

Dr. Iman El-Hariry, Chief Medical Officer of Erytech Inc., added: “We were able to reach this point because of the extraordinary effort of the employees at ERYTECH, the investigators for the clinical trials and most importantly, the patients who participated in the clinical trials and their families. We are looking forward to the potential to offer patients with ALL another effective treatment option with a favorable safety profile.”

For more details, go to: http://erytech.com/erytech-submits-ema-marketing-authorization-application-for-graspa-to-treat-acute-lymphoblastic-leukemia/