|[July 22, 2014]
ERYTECH Announces Enrollment of First Patient in Phase I/II Study of ERY-ASP in Acute Lymphoblastic Leukemia in the United States
LYON, France --(Business Wire)--
ERYTECH Pharma (Paris:ERYP) (Euronext Paris: FR0011471135 - ERYP),
the French biopharmaceutical company that develops innovative 'tumor
starvation' treatments for acute leukemia and other oncology indications
with unmet medical needs, announces the enrollment of the first patient
in its Phase I/II study with ERY-ASP in Acute Lymphoblastic Leukemia in
the United States of America.
ERY-ASP, in Europe know as GRASPA®1, is a new L-asparaginase
product, with a safer and broader range of clinical use than existing
forms thanks to the entrapment and protection of the enzyme inside red
blood cells. In Europe, ERY-ASP is in a Phase III clinical trial in
relapsing Acute Lymphoblastic Leukemia (ALL), in Phase IIb in Acute
Myeloid Leukemia (AML) and in Phase II in pancreas cancer.
In the USA, the safety profile of ERY-ASP is being confirmed in a dose
escalating Phase I/II study in 12 to 18 ALL patients. The study has been
authorized by the FDA in 2013 and three centers are currently open for
patient recruitment: The University of Chicago, Duke University Medical
Center and Ohio State University. Professor Larson, Director of the
Hematological Malignancies Clinical Research Program at the University
of Chicago is the principal investigator of the study.
The first patient has been enrolled and treated last week in Columbus,
Ohio. The investigational product has been produced at ERYTECH's
manufacturing facility in Philadelphia. Thanks to a manufacturing
agreement with the American Red Cross, this facility is fully
operational at GMP level for the production of clinical batches.
"L-asparaginase is an important weapon in the treatment of patients
with ALL, but we are often limited by the toxicities related to this
drug. Erytech's formulation in red blood cells looks promising, and may
open opportunities to treat the more fragile and older patients. I am
very enthusiastic to particpate in this clinical trial", says Dr
Rebecca Klisovic, investigator at the Ohio State University.
"The start of this clinical trial in the United States is an
important step in ERYTECH's value creation strategy. Entering the world
largest healthcare market was one of the key value drivers put forward
in our IPO. We have in the meantime set up ERYTECH Inc, a wholly owned
subsidiary in the US, added a US based board member and added
specialized US investors to our shareholder base. With this trial we are
continuing to build our foothold in the US." adds Pierre-Olivier
Goineau, COO of ERYTECH Pharma.
About ERYTECH and ERY-ASP/GRASPA®: www.erytech.com
is a French biopharmaceutical company providing new prospects for cancer
patients, particularly those with acute leukemia and selected solid
tumors. The company is also developing other indications in solid tumors
and certain orphan indications outside oncology.
listed on Euronext regulated market in Paris. (ISIN code: FR0011471135,
ticker: ERYP) and is part of the CAC All Shares, CAC Healthcare, CAC
Pharma & Bio, CAC Small, CAC Mid&Small, CAC All Tradable and Next
Biotech indexes. ERYTECH shares are eligible to PEA-PME (French share
savings plan for SMEs).
For more information about the Company, please read About
ERYTECH and ERY-ASP/GRASPA
This document may contain
forward-looking statements, forecasts and estimates ("Statements") with
respect to the financial situation, the results of operations, the
strategy, the project and to the anticipated future performance of
ERYTECH Pharma. Documents filed by ERYTECH Pharma with the French
Autorité des Marchés Financiers (www.amf-france.org),
also available on our website (www.erytech.com)
describe such risks and uncertainties for which ERYTECH Pharma makes no
representations or warranty as to their accuracy or fairness.
Furthermore, such Statements only speak as of the date of the
publication of this document. ERYTECH disclaims any obligation to update
any such Statements except to the extent required by French law.
For more information about Forward-looking information, please read Forward-looking
1 GRASPA® is the future tradename of the product in for use
in ALL and AML in Europe; ERY-ASP is the development name in other
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