Business Wire

ERYTECH Announces Publication of Two Articles Describing Clinical Results With ERY-ASP/GRASPA

Del

Regulatory News:

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, announces the publication of two peer-reviewed manuscripts describing clinical results obtained with ERY-ASP/GRASPA®.

The first article, published in the September 2015 issue of the American Journal of Hematology, entitled ”A Phase 2 study of L-asparaginase encapsulated in erythrocytes in elderly patients with Philadelphia chromosome negative acute lymphoblastic leukemia: the GRASPALL/GRAALL-SA2-2008 study” describes the results of a dose-escalating Phase 2 study, evaluating the safety and efficacy of GRASPA in thirty patients ≥ 55 years of age with newly diagnosed Philadelphia negative acute lymphoblastic leukemia (ALL). The study concludes that the addition of GRASPA to standard induction chemotherapy regimen, especially at the 100 IU/kg dose level, is feasible in elderly patients without excessive toxicity and associated with durable asparagine depletion.

The article can be found on-line at: http://www.ncbi.nlm.nih.gov/pubmed/26094614

The second article, published in the October 2015 issue of Pancreas, entitled “Asparagine Synthetase Expression and Phase I Study With L-Asparaginase Encapsulated in Red Blood Cells in Patients With Pancreatic Adenocarcinoma” evaluates the expression of asparagine synthetase (ASNS) in over 500 pancreatic cancer tumor biopsies and presents the results of a Phase 1 study in 12 patients with metastatic pancreatic cancer. 79.4% of tumor biopsies analyzed had no or low ASNS expression with high concordance between primary tumor and metastases. In the Phase 1 study, ERY-ASP was well tolerated and no dose limiting toxicities were identified.

The article can be found on-line at: http://www.ncbi.nlm.nih.gov/pubmed/26355551

Iman El-Hariry, Chief Medical Officer of ERYTECH, comments: “Both studies provide additional support for the potential use of our lead product candidate ERY-ASP/GRASPA in very difficult to treat patient populations. The use of asparaginase in elderly ALL patients and metastatic pancreatic cancer patients has been limited by excessive toxicity so far. The favorable safety profile observed with ERY-ASP in these patients provided support for our ongoing Phase 1 study in adult ALL in the United States, our ongoing Phase 2 studies in acute myeloid leukemia patients over 65 years of age and our ongoing Phase 2 study in metastatic pancreatic carcinoma.”

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

Created 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 has recently announced positive efficacy and safety results from its completed Phase 2/3 pivotal clinical trial in Europe with its lead product candidate, ERY-ASP, also known under the trade name GRASPA®, in children and adults with relapsed or refractory ALL. ERYTECH also has an ongoing Phase 1 clinical trial of ERY-ASP in the United States in adults with newly diagnosed ALL, and a Phase 2 clinical trial in Europe evaluating GRASPA as a first-line therapy for the treatment of elderly patients with AML, each in combination with chemotherapy.

ERY-ASP 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.

Every year over 50,000 patients in Europe and the United States are diagnosed with ALL or AML. For about 80% of these patients, mainly adults and relapsing patients, current forms of L-asparaginase cannot be used due to their toxicity or as a result of allergic reactions. ERYTECH believes that the safety and efficacy profile of ERY-ASP/GRASPA®, as observed in its Phase 2/3 pivotal clinical trial, offers an attractive alternative option for the treatment of leukemia patients.

ERYTECH believes that ERY-ASP 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. In addition to its current product candidates that focus on using encapsulated enzymes to induce tumor starvation, ERYTECH is exploring the use of its platform for developing cancer vaccines and enzyme replacement therapies.

The EMA and the U.S. Food and Drug Administration (FDA) have granted orphan drug designations for ERY-ASP/GRASPA for the treatment of ALL, AML and pancreatic cancer. ERYTECH produces ERY-ASP 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 ERY-ASP for ALL and AML in Europe with Orphan Europe (Recordati Group), and for ALL in Israel with TEVA, who will market the product under the GRASPA® brand name.

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 document may contain forward-looking statements and estimates with respect to the financial position, results of operations, business strategy, plans, objectives 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 the 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 the publication of this document. 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 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.

Contact information

ERYTECH
Gil Beyen
Chairman and CEO
Tel: +33 4 78 74 44 38
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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

AstraZeneca’s Calquence (acalabrutinib) Shows Potential in Chronic Lymphocytic Leukaemia Trials10.12.2017 22:45Pressemelding

AstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, today presented results from the Phase Ib/II ACE-CL-003 clinical trial (Abstract #432) and updated results from the Phase I/II ACE-CL-001 (Abstract #498) clinical trial that are testing Calquence (acalabrutinib) alone and in combination for the treatment of chronic lymphocytic leukaemia (CLL) in multiple treatment settings. The findings were presented during two oral sessions at the 59th American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “These data add to the growing body of evidence that supports the potential of Calquence in the treatment of chronic lymphocytic leukaemia, a life-threatening disease that affects tens of thousands of people aroun

Celgene Corporation and bluebird bio Announce Updated Results from Ongoing Multicenter Phase 1 Study of bb2121 Anti-BCMA CAR T Cell Therapy in Patients with Late Stage Relapsed/Refractory Multiple Myeloma at ASH Annual Meeting10.12.2017 15:30Pressemelding

Celgene Corporation (NASDAQ: CELG) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that updated results from the ongoing CRB-401 Phase 1 clinical study of bb2121, an investigational anti-B-cell maturation antigen (BCMA) CAR T cell therapy, in 21 patients with late-stage relapsed/refractory multiple myeloma will be presented in an oral presentation at the American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia. The objective of this Phase 1 dose-escalation study is to evaluate safety and efficacy of bb2121 and determine a recommended Phase 2 dose. “Celgene has a longstanding commitment to patients with multiple myeloma through our extensive research efforts in this deadly blood cancer,” said Nadim Ahmed, President, Hematology and Oncology for Celgene. “Looking ahead, we see BCMA as an important target in this disease and we believe bb2121 has the potenti

Kite Announces Long-Term Data From Pivotal ZUMA-1 Study of Yescarta™ (Axicabtagene Ciloleucel) in Patients With Refractory Large B-cell Lymphoma10.12.2017 15:30Pressemelding

Kite, a Gilead Company (Nasdaq: GILD), announced long-term follow-up data from the pivotal ZUMA-1 study of Yescarta™ (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. With a minimum follow-up of one year after a single infusion of Yescarta (median follow-up of 15.4 months), 42 percent of patients continued to respond to therapy, including 40 percent with a complete remission. Detailed results from this updated analysis were simultaneously presented at the Annual Meeting of the American Society of Hematology (ASH) in Atlanta and published in The New England Journal of Medicine. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171210005072/en/ Yescarta is the first chimeric antigen receptor T (CAR T) cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult

Takeda and Seattle Genetics to Present Positive Data from Phase 3 ECHELON-1 Clinical Trial Evaluating ADCETRIS® (brentuximab vedotin) in Frontline Advanced Hodgkin Lymphoma10.12.2017 13:00Pressemelding

Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (NASDAQ: SGEN) today announced that data from the Phase 3 ECHELON-1 clinical trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in untreated advanced classical Hodgkin lymphoma will be presented in the Plenary Scientific Session at the 59th American Society of Hematology (ASH) annual meeting on Sunday, December 10, 2017. The data were also simultaneously published online in the New England Journal of Medicine and will be published in the print edition on January 25, 2017. Topline data were reported in June 2017 demonstrating the ECHELON-1 trial met its primary endpoint of a statistically significant improvement in modified progression-free survival (modified PFS) per Independent Review Facility (IRF) versus the control arm. ADCETRIS is an antibody-drug con

AstraZeneca’s Calquence (acalabrutinib) Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma Trial9.12.2017 18:00Pressemelding

AstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, today presented results from the open-label, single-arm Phase II ACE-LY-004 clinical trial, which served as the basis for the recent US Food and Drug Administration (FDA) accelerated approval of Calquence (acalabrutinib). The findings were presented for the first time during an oral session at the 59th American Society of Hematology (ASH) Annual Meeting & Exhibition in Atlanta, USA and demonstrate the safety profile and efficacy of acalabrutinib in the management of previously-treated mantle cell lymphoma (MCL). Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The results presented for the first time to the medical community highlight the potential of Calquence as a treatment for people with relapsed or refractory mantle cell l

Sustained Benefit in Patients with Relapsed/Refractory Mantle Cell Lymphoma Demonstrated by 3.5 Year Follow-up Data of Imbruvica®▼(ibrutinib)9.12.2017 17:19Pressemelding

Today, Janssen-Cilag International NV (“Janssen”) announced results of a pooled analysis of relapsed/refractory (r/r) mantle cell lymphoma (MCL) patients treated with Imbruvica® (ibrutinib). The extended follow-up data demonstrated that patients treated with ibrutinib earlier (at first relapse) experienced the best clinical outcomes, both in terms of efficacy and tolerability. These data (abstract #151) were presented in an oral presentation at the 59th Annual American Society of Hematology (ASH) Meeting and Exposition in Atlanta, GA.1,2 Ibrutinib, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company. “Data from this large clinical trial data set with extended follow-up support the early use of ibrutinib in patients with relapsed or refractory mantle cell lymphoma,” said Simo

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom