ERYTECH Announces Oral Presentations of GRASPA® Phase III Results at ASCO and EHA Annual Meetings

LYON, France--()--Regulatory News:

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris - ERYP; OTC US - EYRYY), the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, announces that the data related to GRASPA® Phase 3 pivotal program in Acute Lymphoblastic Leukemia (ALL) will be the subject of oral presentations at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), May 29 - June 2, Chicago, USA, and at the 20th Congress of European Hematology, June 11 - 14, Vienna, Austria. A poster on the design of the ongoing Phase IIb study in Acute Myeloid Leukemia (AML) will also be presented at ASCO.

The data to be presented will include full Phase III results of the GRASPIVOTALL trial, a controlled, multicenter trial comparing GRASPA® (development name: ERY001) to native L-asparaginase (L-ASP) in children and adults suffering from relapsed or refractory ALL. Positive top line data were made available end of last year and demonstrated that the trial met both of its primary endpoints. A significant reduction of clinical hypersensitivity was observed with GRASPA® while maintaining asparaginase activity longer than with L-ASP in the control arm. The study also showed favorable results in patients with prior allergies to asparaginase.

Details for the oral presentations are as follows:

ASCO (American Society of Clinical Oncology)

  • Clinical activity of ERY001 (erythrocyte encapsulated l-asparaginase) and native l-asparaginase (L-ASP) in combination with COOPRALL regimen in Phase III randomized trial in patients with relapsed acute lymphoblastic leukemia (ALL)
    Oral abstract session: Leukemia, Myelodysplasia, and Transplantation
    Presenter: Prof. Dr. Yves Bertrand, Institute for Pediatric Hematology and Oncology, Lyon (France)
    Date: Saturday, May 30, 2015, Time: 2:15PM, Location: E Arie Crown Theater
    Abstract is available on line on http://am.asco.org/abstracts

EHA (European Hematology Association)

  • Clinical activity of ERY001 (erythrocyte encapsulated l-asparaginase) and native l-asparaginase (L-ASP) in combination with COOPRALL regimen in Phase III randomized trial in patients with relapsed acute lymphoblastic leukemia (ALL)
    Topic: Acute lymphoblastic leukemia - Clinical
    Session Title: Translational studies in ALL
    Date: Saturday, June 13, 12:30 - 12:45, Room C1
    Abstracts will be published online on May 21 at the EHA website at www.ehaweb.org

At ASCO, ERYTECH will also present a poster on the design of its ongoing Phase IIb study in Acute Myeloid Leukemia.

  • GRASPA-AML 2012-01 study: A multicenter, open, randomized Phase 2b trial evaluating ERY001 (L-asparaginase encapsulated in red blood cells) plus low-dose cytarabine vs low-dose cytarabine alone, in treatment with newly diagnosed acute myeloid leukemia (AML) elderly patients, unfit for intensive chemotherapy
    Poster session: Leukemia, Myelodisplasia and Transplantation
    Date: Sunday, May 31st, 2015, 08:00 AM - 11:30 AM
    Presenter: Dr. Xavier Thomas, Hospital Lyon Sud, Lyon, France
    Abstract is available on line on http://am.asco.org/abstracts

About ASCO and EHA

ASCO, the American Society of Hematology, is a professional oncology society committed to conquering cancer through research, education, prevention and delivery of high-quality patient care. ASCO’s Annual Meeting is the world largest event on clinical oncology which annually gathers more than 30,000 specialists interested in the latest achievements in the field of cancer treatment.

EHA, the European Hematology Association, promotes excellence in patient care, research and education in hematology. The annual congress of EHA is the most important European conference regarding latest advances in hematology gathering more than 9,500 participants from all parts of the globe.

About ERYTECH and ERY-ASP/GRASPA®: www.erytech.com

Founded in Lyon in 2004, ERYTECH is a French biopharmaceutical company providing new prospects for cancer patients, particularly those with acute leukemia and selected solid tumors. By encapsulating the asparaginase enzyme in red blood cells, ERYTECH has developed ERY-ASP/GRASPA®, an original treatment that targets cancer cells through “tumor starvation” while significantly reducing the side effects for patients. ERY-ASP/GRASPA® has recently announced positive Phase III data in Acute Lymphoblastic Leukemia (ALL) and is in Phase IIb clinical trial in Acute Myeloid Leukemia (AML) in Europe. The product is also in Phase I/II clinical development in ALL in the USA.

Every year about 50,000 patients are diagnosed with Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML), the two forms of acute leukemia. Today, for about 80% of these patients, mainly adults and relapsing patients, current forms of asparaginase cannot be used due to their toxicity. With a presumed improved safety profile, ERY-ASP/GRASPA® is being developed to allow all leukemia patients to be treated, even the most fragile ones, representing a market opportunity of more than EUR 1 billion.

The company is also developing other indications in solid tumors and certain orphan indications outside oncology. A Phase II study in pancreas cancer is ongoing and the company is exploring other solid tumor indications for ERY-ASP. ERYTECH has obtained orphan drug designations for ERY-ASP/GRASPA® in ALL, AML and pancreas cancer, both in Europe and the USA, and has its own GMP-approved and operational manufacturing site in Lyon (France), and a site for clinical production in Philadelphia (USA). The company has concluded licensing and distribution partnership agreements for ALL and AML in Europe with Orphan Europe (Recordati Group), and for ALL with TEVA in Israel.

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, Enternext Tech 40 and Next Biotech indexes. ERYTECH is also listed in the US under an ADR level 1 program (OTC, ticker EYRYY).

Forward-looking information

This document may contain forward-looking statements and estimates with respect to the financial situation, the results of operations, the strategy, the project and to the 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 the Company's control. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results, the financial condition, performance or achievements of ERYTECH, or industry results, may turn out to be materially different from any 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 our 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 the publication of this document. ERYTECH disclaims any obligation to update any such forward-looking statement. 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 the Company’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 French law.

Contacts

ERYTECH
Gil Beyen, Tel: +33 4 78 74 44 38
Chairman and CEO
investors@erytech.com
or
NewCap
Julien Perez / Emmanuel Huynh
Investor relations
Nicolas Merigeau
Press relations
Tel: +33-1-44-71-98-52
erytech@newcap.fr

Contacts

ERYTECH
Gil Beyen, Tel: +33 4 78 74 44 38
Chairman and CEO
investors@erytech.com
or
NewCap
Julien Perez / Emmanuel Huynh
Investor relations
Nicolas Merigeau
Press relations
Tel: +33-1-44-71-98-52
erytech@newcap.fr