LYON, France--(BUSINESS WIRE)--Apr. 4, 2017--
Regulatory News:
ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) a French clinical-stage
biopharmaceutical company developing innovative therapies by
encapsulating therapeutic drug substances inside red blood cells, today
announced the launch of an investigator-initiated study to evaluate
eryaspase, also known by the trade name GRASPA®, in patients with acute
lymphoblastic leukemia (ALL). The study will take place in seven Nordic
countries and be conducted in collaboration with the Nordic Society of
Pediatric Hematology and Oncology (NOPHO).
The single arm, multi-center, multi-national Phase 2 study is expected
to enroll approximately 30 patients at 23 sites across seven Nordic and
Baltic countries: Denmark, Finland, Norway, Sweden, Iceland, Lithuania
and Estonia. The main objectives of the study are to evaluate the
biological (pharmacokinetic and pharmacodynamic) activity, safety, and
immunogenicity profile of eryaspase in combination with the NOPHO ALL
2008 multi-agent chemotherapy protocol administered as second-intention
treatment for children or adult ALL patients (1 to 45 years old) who
experience hypersensitivity reactions to PEG-asparaginase or silent
inactivation. The study is expected to start in April 2017 and continue
for approximately 2 years.
Dr. Birgitte Klug Albertsen, Principal Investigator of the trial,
commented, "Depending on the asparaginase preparation,
hypersensitivity reactions can occur at frequencies between 13% and 30%
of children and adults with ALL, making the therapy ineffective.
Eryaspase, or L-asparaginase encapsulated in red blood cells, may be
able to limit these reactions and maintain treatment effectiveness. We
look forward to evaluating this combination therapy to determine its
clinical benefits for both pediatric and adult patients with
hypersensitivity reactions to the PEG-asparaginase chemotherapy."
Dr. Iman El-Hariry, Chief Medical Officer of Erytech Pharma, added, "Collaborating
with NOPHO is an exciting opportunity for Erytech to evaluate eryaspase
in this specific patient population, with the potential to demonstrate
expanded application of our technology to treat blood cancers where drug
resistance and hypersensitivity clinical reactions to first-line
chemotherapies is common. This study aligns with our global strategy to
develop the ERYCAPS® technology with an increased tolerability and
efficacy profile for patients who may respond to L-asparaginase when it
is delivered through encapsulated red blood cells."
About ERYTECH: 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
plans to pursue regulatory approvals for its lead product candidate,
eryaspase, also known as ERY-ASP or under the trade name GRASPA®, having
achieved 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. ERYTECH
believes that eryaspase also 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.
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. 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. The European
Medicines Agency (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.
In addition to eryaspase, ERYTECH is developing two other product
candidates that focus on using encapsulated enzymes to induce tumor
starvation. The company is leveraging the ERYCAPS platform for
developing cancer immunotherapies (ERYMMUNE) and enzyme therapies beyond
oncology (ERYZYME).
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
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 pipeline product candidates that the
candidates will receive the necessary regulatory approvals or that they
will prove to 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 ERYTECH Pharma with the
French Autorité des Marchés Financiers (www.amf-france.org),
also available on ERYTECH’s website (www.erytech.com)
describe such risks and uncertainties. Given these uncertainties, no
representations are made as to the accuracy or fairness of such
forward-looking statements, forecasts and estimates. Furthermore,
forward-looking statements, forecasts and estimates only speak as of the
date of this press release. Readers are cautioned not to place undue
reliance on any of these forward-looking statements. ERYTECH disclaims
any obligation to update any such forward-looking statement, forecast or
estimates to reflect any change in ERYTECH’s expectations with regard
thereto, or any change in events, conditions or circumstances on which
any such statement, forecast or estimate is based, except to the extent
required by law.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170404005946/en/
Source: ERYTECH Pharma
ERYTECH
Gil Beyen
Chairman and CEO
Eric
Soyer
CFO and COO
+33 4 78 74 44 38
investors@erytech.com
or
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or
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Media relations
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