ERYTECH Reports Determination of the Recommended Pivotal Phase 3 Dose of eryaspase in its U.S. Phase 1 Study in First Line Adult ALL
ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced the determination of the recommended pivotal Phase 3 dosing from its U.S. Phase 1 dose escalation study with eryaspase (GRASPA®) in first line treatment of adult ALL patients.
The U.S. Phase 1 study with eryaspase (GRASPA) is an open label dose escalation study evaluating the safety of eryaspase in combination with CALGB 8811 protocol for first line treatment of adult ALL patients. The study is performed at five clinical sites across the United States. Prof. Dr. Richard Larson, director of the Hematologic Malignancies Clinical Research Program at the University of Chicago, is the principal investigator of the study.
ERYTECH recently announced that all patients had been treated in the third dose escalation cohort of this Phase 1 study. The steering committee of the study reviewed the safety data of all three treatment cohorts and agreed to pursue further development at the dose level of 100 U/kg. This dose level had been previously recommended following ERYTECH’s Phase 2 study in elderly ALL patients. It is also the dose level used in the Phase 2b study in second line, metastatic pancreatic cancer, that recently reported positive efficacy and safety results, and in the ongoing Phase 2b study in AML, from which top-line results are expected by the end of this year.
In parallel with running an expansion cohort of this Phase 1 study at this recommended dose, ERYTECH will potentially initiate the steps toward the launch of a pivotal Phase 3 study in first line adult ALL patients at this dose level.
About ERYTECH and eryaspase (GRASPA®): 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 development of products that target the amino acid metabolism of cancer, depriving them of nutrients necessary for their survival.
The company’s lead product, eryaspase, also known under the trade name GRASPA®, 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. L-asparaginase has been a standard component of multi-agent chemotherapy for the treatment of acute lymphoblastic leukemia (ALL), but side effects limit treatment, especially in adults and patients with weak performance status. With its improved safety profile, eryaspase aims to provide L-asparaginase to patients who cannot tolerate current non-encapsulated asparaginases.
Eryaspase achieved positive efficacy and safety results in a Phase 2 study in elderly patients with ALL, and a Phase 2/3 study in children and adults with relapsed or refractory ALL. ERYTECH believes that the positive results of its Phase 2b clinical study in second-line metastatic pancreatic cancer are significant indicators of eryaspase as a potential treatment approach in solid tumors. ERYTECH also has an ongoing Phase 1 clinical study of eryaspase in the United States in adults with newly diagnosed ALL and a Phase 2b clinical study in Europe in elderly patients with newly diagnosed acute myeloid leukemia (AML), each in combination with chemotherapy.
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, erymethionase and eryminase, that focus on using encapsulated enzymes to target cancer metabolism and induce tumor starvation. ERYTECH is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies (ERYMMUNE) and enzyme replacement therapies (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).
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.
Director of Investor Relations
+33 4 78 74 44 38
+1 917 312 5151
The Ruth Group
+1 646 536 7012
+1 508 280 6592
+33 1 44 71 98 52
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
NMI Agrees to Acquire Creditcall to Expand EMV and Omnichannel Capabilities20.2.2018 16:04 | Tiedote
NMI, a leading provider of payments enablement technology for independent sales organizations (ISOs), independent software vendors (ISVs), value-added resellers (VARs) and payment facilitators, today announced it has signed a definitive agreement to acquire Creditcall, an omnichannel payment gateway and EMV solutions provider. With offices in Bristol, England, and New York, and customers throughout many regions of the world, Creditcall will give NMI a global presence and access to new markets. This acquisition will continue to differentiate NMI from traditional payment gateway providers by further expanding its omnichannel and EMV capabilities, creating a one-of-a-kind payment gateway platform supporting all channels of commerce including retail, e-commerce, mobile and unattended. “The payment technology requirements of today’s merchants are more complex than ever—they need to accept and process payments in all sales channels and environments,” said Roy Banks, chief executive officer o
Philip Morris International and Scuderia Ferrari Partner Together to Advance the Vision of a World Free of Tobacco Smoke20.2.2018 16:00 | Tiedote
Philip Morris International Inc. (NYSE/Euronext Paris: PMI) and Scuderia Ferrari have extended their partnership until 2021. Their successful collaboration spans more than 40 years. As of today, the partnership will be exclusively focused on advancing the cause of a smoke-free world – a world in which all people who would otherwise continue smoking switch from the most harmful form of nicotine consumption – cigarettes – to scientifically substantiated less harmful alternatives that are smoke-free. “We want to give the world’s 1.1 billion men and women who smoke the opportunity to make better and informed choices. We are committed to use all available resources, including our motorsports related activities, to accelerate momentum around this revolutionary change for the benefit of people who smoke, public health and society at large. We deeply appreciate Scuderia Ferrari’s support in this cause,” said PMI’s Chief Executive Officer, André Calantzopoulos. Creating global awareness of the
Legal & General Announces New Partnership with Technology Partner Slice Labs to Roll Out ‘On-Demand’ Homeshare Insurance20.2.2018 16:00 | Tiedote
Legal & General, the FTSE 100 financial services group and leading home insurance provider, has today announced a new technology partnership with Slice Labs Inc with the aim to offer a new on-demand homeshare insurance proposition for customers. The last few years has seen an increase in the popularity of on-demand insurance which allows customers to use a mobile app to purchase insurance to protect their personal belongings, car, or home when ‘at risk’. On-demand insurance offers customers flexibility of cover that is easy and convenient to buy and paying only for what they need when they need it. The partnership with Slice Labs Inc is another step in Legal & General’s commitment to invest in new technology and intend to use Slice Labs Insurance Cloud Services™ (ICS) platform to roll out on-demand homeshare insurance and other products to their customers. Founded in October 2015 Slice Labs provides tailored insurance offerings for home sharing costs. The two companies are, working tog
Wipro Positioned in ‘Winner’s Circle’ of HfS Blueprint Report on Enterprise Blockchain Services 201720.2.2018 15:20 | Tiedote
Wipro Limited (NYSE:WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has been positioned in the ‘Winner's Circle’ of Enterprise Blockchain service providers by HfS Research in the market study ‘HfS Blueprint Report on Enterprise Blockchain Services 2017’. This report was authored by Saurabh Gupta, Chief Strategy Officer, HfS Research. In the Enterprise Blockchain Services 2017 Report, HfS evaluated the blockchain capabilities of 21 service providers across the value chain of Strategic Advisory, Prototype Development, Production build and System Integration. The 'Winner's Circle' of the HfS Blueprint represents service providers who excel at both execution and innovation dimensions. The report states that Wipro is a leading blockchain services provider with scale, robust partnership ecosystem, in-house tools and live client engagements. Phil Fersht, CEO, HfS Research said, “The blockchain mo
Jetcraft Opens First London Office20.2.2018 13:55 | Tiedote
Jetcraft, the global leader in business aircraft sales and acquisitions, announces the opening of its first London office through its new UK company, Jetcraft Global (UK) Limited. The new London base cements Jetcraft’s commitment to the European region and demonstrates its confidence in the UK as a continuing hub of business opportunity. Chad Anderson, President at Jetcraft, says: “The opening of our London office comes as Jetcraft celebrates another record year -- with 93 transactions completed in 2017 – and rounds off a remarkable decade of more than 550 transactions exceeding $10bn in value. Our new London location creates even more ways for us to serve our clients and we are excited about the opportunities it presents.” Jetcraft’s new office comes at a time of significant growth in resources for the company, with the appointment of four senior sales posts from within the team, including Sean O’Leary, who will take on the role of Sales Director based in the new London office. Additi
Inmarsat Selects Sigma Systems for Large-Scale BSS Transformation20.2.2018 13:00 | Tiedote
Sigma Systems, the global leader in catalog-driven software, is pleased to announce a multi-year contract with Inmarsat, the leading provider of global mobile satellite communications services. With the digital revolution moving forward at great speed, Inmarsat recognized that a catalog-driven, agile approach to B/OSS was key to enabling more effective connections with their customers and partners through the products and services they sell. To this end, Inmarsat awarded Sigma a multi-year contract for its Catalog, CPQ (Configure Price Quote) and Order Management products to support Inmarsat’s next-generation satellite services across all customer verticals. Kirk Wilkenson, VP OneIT Programme at Inmarsat, commented: “Inmarsat is focused on driving customer value and making it simpler for customers and partners to work with us. We are launching a new B/OSS platform, utilizing a service-oriented component architecture, as part of a broader service delivery transformation to support our c
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme