ERYTECH Completes Patient Enrollment in Phase 2 Trial of eryaspase (GRASPA®)

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), a French biopharmaceutical company developing ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, today announced the final patient has been enrolled in its Phase 2 trial of eryaspase, also known as ERY-ASP or GRASPA®, for the treatment of pancreatic cancer.
The multicenter, randomized Phase 2 trial is evaluating eryaspase as a
second-line treatment of patients with metastatic pancreatic cancer. In
the study conducted in France, eryaspase was added to the standard of
care (currently Gemcitabine or FOLFOX regimen) and then compared to the
standard of care alone in a 2-to-1 randomization. The primary endpoint
of the trial is progression-free survival (PFS) at four months.
The trial has completed enrollment of 139 patients and we expect to
report primary results from this trial by early 2017.
“The Phase 2 trial of eryaspase for pancreatic cancer is, to our
knowledge, the largest cohort of solid tumor patients treated with an
asparaginase-based product to date,” said Gil Beyen, Chairman and CEO of
ERYTECH. “Previously, deprivation of asparagine has shown to limit
growth of pancreatic and other solid tumors in preclinical models, but
clinical proof of concept has not yet been established. We believe a
positive efficacy signal in this trial could open a potentially large
application area for asparagine depletion in certain solid tumors.”
About pancreatic cancer:
Pancreatic cancer is a disease in which malignant (cancer) cells are
found in the tissues of the pancreas. Every year there are about 150,000
new cases of pancreatic cancer diagnosed in Europe and the United
States. Pancreatic cancer is a particularly aggressive cancer, with a
five-year survival rate of less than 10% and is currently the fourth
most common cause of cancer death in the EU for men and women.
Pancreatic cancer could be a suitable indication for eryaspase because
it involves a large proportion of tumors that are believed to be
sensitive to asparagine depletion, allowing it to potentially have an
impact.
About ERYTECH and eryaspase (ERY-ASP/GRASPA®): www.erytech.com
Founded in Lyon, France in 2004, ERYTECH is a clinical-stage
biopharmaceutical company developing innovative therapies for rare forms
of cancer and orphan diseases. Leveraging its proprietary ERYCAPS
platform, which uses a novel technology to encapsulate therapeutic drug
substances inside red blood cells, ERYTECH has developed a pipeline of
product candidates targeting markets with high unmet medical needs.
ERYTECH’s initial focus is on the treatment of blood cancers, including
acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), by
depriving tumors of nutrients necessary for their survival. ERYTECH has
recently filed for European Marketing Authorization for its lead product
candidate, eryaspase, also known as ERY-ASP or under the trade name
GRASPA®, following positive efficacy and safety results from its
completed Phase 2/3 pivotal clinical trial in Europe in children and
adults with relapsed or refractory ALL. ERYTECH also has an ongoing
Phase 1 clinical trial of eryaspase in the United States in adults with
newly diagnosed ALL, and a Phase 2b clinical trial in Europe in elderly
patients with newly diagnosed AML, each in combination with chemotherapy.
Eryaspase 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, from circulating blood plasma. Every year
over 50,000 patients in Europe and the United States are diagnosed with
ALL or AML. For about 80% of these patients, mainly adults and relapsing
patients, current forms of L-asparaginase cannot be used due to their
toxicity or as a result of allergic reactions. ERYTECH believes that the
safety and efficacy profile of eryaspase (GRASPA®), as observed in its
Phase 2/3 pivotal clinical trial, offers an attractive alternative
option for the treatment of leukemia patients.
ERYTECH believes that eryaspase has the potential as a treatment
approach in solid tumors and is conducting a Phase 2 clinical trial in
Europe in patients with metastatic pancreatic cancer.
In addition to its current product candidates that focus on using
encapsulated enzymes to induce tumor starvation, ERYTECH is exploring
the use of its platform for developing cancer vaccines and enzyme
replacement therapies.
The EMA and the U.S. Food and Drug Administration (FDA) have granted
orphan drug designations for eryaspase for the treatment of ALL, AML and
pancreatic cancer. ERYTECH produces eryaspase at its own GMP-approved
and operational manufacturing site in Lyon (France), and at a site for
clinical production in Philadelphia (USA). ERYTECH has entered into
licensing and distribution partnership agreements for eryaspase for ALL
and AML in Europe with Orphan Europe (Recordati Group), and for ALL in
Israel with TEVA, which will market the product under the GRASPA® brand
name.
ERYTECH is listed on Euronext regulated market in Paris (ISIN code:
FR0011471135, ticker: ERYP) and is part of the CAC Healthcare, CAC
Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150
and Next Biotech indexes. ERYTECH is also listed in the U.S. under an
ADR level 1 program (OTC, ticker EYRYY).
Forward-looking information
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