ERYTECH Announces Resubmission of European Marketing Authorization Application for GRASPA in Acute Lymphoblastic Leukemia
The GRASPALL Phase 2/3 trial, showed positive efficacy and safety results with GRASPA in combination with chemotherapy as compared to native L-asparaginase in patients with R/R ALL. The patients treated with GRASPA experienced a mean duration of L-asparaginase activity that was almost twice as long as for patients receiving native L-asparaginase. GRASPA also had a favorable safety profile in the trial and no patients who received GRASPA experienced an allergic reaction, as compared to 46% of the patients who received native L-asparaginase. Patients in the GRASPA treatment arm also had overall higher complete remission rates during induction, and GRASPA was associated with fewer drug-related adverse events.
In
Dr.
About Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia (ALL) is a blood cancer affecting mainly
the white blood cells. ALL is most prevalent in children between the
ages of two and five, although adults are also affected.
About ERYTECH and eryaspase (GRASPA®): www.erytech.com
Founded in
The company’s lead product, eryaspase, also known under the trade name GRASPA®, 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. L-asparaginase has been a standard component of multi-agent chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), but side effects limit treatment, especially in adults and patients with weak performance status. With its improved safety profile, eryaspase aims to provide L-asparaginase to patients who cannot tolerate current non-encapsulated asparaginases.
Eryaspase demonstrated positive efficacy and safety results in various
studies in ALL, including in a Phase 2 study in elderly patients with
ALL and a Phase 2/3 study in children and adults with relapsed or
refractory ALL, as well as in pancreatic cancer, where it achieved
positive results in a Phase 2b study of second-line treatment of
patients with metastatic pancreatic cancer. ERYTECH believes that the
positive results of its Phase 2b clinical study in second-line
metastatic pancreatic cancer are significant indicators of eryaspase as
a potential treatment approach in solid tumors. ERYTECH also has an
ongoing Phase 1 clinical study of eryaspase in
ERYTECH produces eryaspase at its own GMP-approved and operational
manufacturing site in
In addition to eryaspase, ERYTECH is developing two other product candidates, erymethionase and eryminase, that focus on using encapsulated enzymes to target cancer metabolism and induce tumor starvation. ERYTECH is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies (ERYMMUNE) and enzyme replacement therapies (ERYZYME).
ERYTECH is listed on
Forward-looking information
This press release contains forward-looking statements, forecasts and
estimates with respect to the clinical development plans, business and
regulatory strategy, and anticipated future performance of ERYTECH and
of the market in which it operates. Certain of these statements,
forecasts and estimates can be recognized by the use of words such as,
without limitation, “believes”, “anticipates”, “expects”, “intends”,
“plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar
expressions. They include all matters that are not historical facts.
Such statements, forecasts and estimates are based on various
assumptions and assessments of known and unknown risks, uncertainties
and other factors, which were deemed reasonable when made but may or may
not prove to be correct. Actual events are difficult to predict and may
depend upon factors that are beyond ERYTECH's control. There can be no
guarantees with respect to ERYTECH’s resubmission of the MAA or that its
product candidates will receive the necessary regulatory approvals or
that they will prove to ultimately be commercially successful.
Therefore, actual results may turn out to be materially different from
the anticipated future results, performance or achievements expressed or
implied by such statements, forecasts and estimates. Documents filed by
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Source: ERYTECH
ERYTECH
Naomi Eichenbaum
Director of Investor
Relations
+33 4 78 74 44 38
+1 917 312 5151
naomi.eichenbaum@erytech.com
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Lee Roth
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