On December 7, 2017 ERYTECH Pharma (Euronext Paris: ERYP) (Nasdaq: ERYP) ("ERYTECH"), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported topline results from its Phase 2b clinical study evaluating eryaspase (GRASPA) for the treatment of acute myeloid leukemia (AML) (Press release, ERYtech Pharma, DEC 7, 2017, View Source [SID1234522449]).

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The open-label, randomized, multi-center clinical study, evaluated eryaspase in newly diagnosed AML patients over the age of 65 and unfit for intensive chemotherapy. The study enrolled a total of 123 patients at 30 European sites. The median age of the patients was 78 years. Patients were randomized two-to-one to receive eryaspase in combination with low-dose cytarabine (LDAC) versus LDAC alone. The primary endpoint in this proof-of concept study was overall survival (OS). The key secondary endpoints included progression free survival, overall response and toxicity. The study was 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.

The study did not meet its primary endpoint of overall survival (OS). The OS Hazard Ratio (HR) was 1.06 (95% CI; 0.70, 1.61). When adjusting for minor imbalances in the main prognostic factors at baseline (age, karyotype and FAB status), the OS HR was 0.98 (95% CI; 0.64, 1.50). The median number of months on treatment was less then 2 months in both treatment arms. The toxicity profile was acceptable and consistent with previously reported data for eryaspase.

"These data reflect the complexity of this disease, particularly in the older age group." commented Iman El-Hariry, MD, PhD, Chief Medical Officer of ERYTECH. "While we are disappointed with the outcome, we are reassured with the safety profile of eryaspase in these very frail and elderly patients."

Gil Beyen, Chairman and CEO of ERYTECH, added, "Although clearly disappointing, these results do not change our commitment to the development of the eryaspase product candidate. Eryaspase has shown positive safety and efficacy results in the treatment of pancreatic cancer and acute lymphoblastic leukemia and we remain committed to bringing this treatment option to patients in these and potential other indications."

ERYTECH will hold a conference call and webcast on Monday, December 11th at 10:00 am EST to discuss the results of this study. The full dataset will be discussed at a scientific congress in 2018.

Investors and analysts wishing to participate can access the call via the following teleconferencing numbers:

USA: +1 833 8186807 United-Kingdom: +080 00323836
Switzerland: +080 0561782 Germany: +080 01815287
France: +080 5081485 Belgium: +080 073308
Sweden: +020 798505 Finland : +080 0412874
Netherlands: +080 00200089

Password: 6983889

The webcast can be followed live online via the following link:

Webcast Link: View Source

An archive of the webcast will be available for 90 days on the "Webcast" section of the Company’s investor relations site at www.erytech.com.

Additionally, a replay of the call will be available for 7 days. To listen to the replay, please dial:

USA: +1 404 537 3406
Participant Password: 6983889

About acute myeloid leukemia (AML)

AML is a form of acute leukemia or blood cancer that results from the improper maturation of myeloid stem cells leading to the production of myeloblasts. The increasing numbers of abnormal blasts crowd out healthy cells in bone marrow (resulting in infection, anemia, and bleeding) and can spread to other parts of body. With about 40,000 new patients per year in Europe and the United States, AML is the most common type of acute leukemia. Affecting mainly the adult and senior patient population, the median age of patients diagnosed with AML is approximately 67 years, and AML represents one of the highest mortality rates among all type of cancers and an important unmet medical need.