LYON, France -- (BUSINESS WIRE) -- Regulatory News:
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 participate 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
ERYTECH 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.
ERYTECH is 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 information
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 regions