ERYTECH Reports Top-line Results of Phase 2b Study of Eryaspase for the Treatment of AML
ERYTECH Pharma (Euronext Paris: ERYP) (Nasdaq: ERYP) ("ERYTECH"), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced topline results from its Phase 2b clinical study evaluating eryaspase (GRASPA®) for the treatment of acute myeloid leukemia (AML).
The open-label, randomized, multi-center clinical study, evaluated eryaspase in newly diagnosed AML patients over the age of 65 and unfit for intensive chemotherapy. The study enrolled a total of 123 patients at 30 European sites. The median age of the patients was 78 years. Patients were randomized two-to-one to receive eryaspase in combination with low-dose cytarabine (LDAC) versus LDAC alone. The primary endpoint in this proof-of concept study was overall survival (OS). The key secondary endpoints included progression free survival, overall response and toxicity. The study was performed in collaboration with Orphan Europe (Recordati Group), ERYTECH’s partner for the anticipated commercialization of GRASPA® for the treatment of ALL and AML in Europe.
The study did not meet its primary endpoint of overall survival (OS). The OS Hazard Ratio (HR) was 1.06 (95% CI; 0.70, 1.61). When adjusting for minor imbalances in the main prognostic factors at baseline (age, karyotype and FAB status), the OS HR was 0.98 (95% CI; 0.64, 1.50). The median number of months on treatment was less then 2 months in both treatment arms. The toxicity profile was acceptable and consistent with previously reported data for eryaspase.
“These data reflect the complexity of this disease, particularly in the older age group.” commented Iman El-Hariry, MD, PhD, Chief Medical Officer of ERYTECH. “While we are disappointed with the outcome, we are reassured with the safety profile of eryaspase in these very frail and elderly patients.”
Gil Beyen, Chairman and CEO of ERYTECH, added, “Although clearly disappointing, these results do not change our commitment to the development of the eryaspase product candidate. Eryaspase has shown positive safety and efficacy results in the treatment of pancreatic cancer and acute lymphoblastic leukemia and we remain committed to bringing this treatment option to patients in these and potential other indications.”
ERYTECH will hold a conference call and webcast on Monday, December 11th at 10:00 am EST to discuss the results of this study. The full dataset will be discussed at a scientific congress in 2018.
Investors and analysts wishing to participate can access the call via the following teleconferencing numbers:
|USA: +1 833 8186807||United-Kingdom: +080 00323836|
|Switzerland: +080 0561782||Germany: +080 01815287|
|France: +080 5081485||Belgium: +080 073308|
|Sweden: +020 798505||Finland : +080 0412874|
|Netherlands: +080 00200089|
The webcast can be followed live online via the following link:
Webcast Link: https://edge.media-server.com/m6/p/o2fziqc6
An archive of the webcast will be available for 90 days on the “Webcast” section of the Company’s investor relations site at www.erytech.com.
Additionally, a replay of the call will be available for 7 days. To listen to the replay, please dial:
USA: +1 404 537 3406
Participant Password: 6983889
About acute myeloid leukemia (AML)
AML is a form of acute leukemia or blood cancer that results from the improper maturation of myeloid stem cells leading to the production of myeloblasts. The increasing numbers of abnormal blasts crowd out healthy cells in bone marrow (resulting in infection, anemia, and bleeding) and can spread to other parts of body. With about 40,000 new patients per year in Europe and the United States, AML is the most common type of acute leukemia. Affecting mainly the adult and senior patient population, the median age of patients diagnosed with AML is approximately 67 years, and AML represents one of the highest mortality rates among all type of cancers and an important unmet medical need.
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 compliance, especially in adults and patients with weak performance status. Eryaspase aims to provide L-asparaginase to patients who cannot tolerate current non-encapsulated asparaginases.
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 the Nasdaq Global Select Market in the United States (ticker: ERYP)and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical results from and the development plans of eryaspase, 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
Summer Business with Yourtyres.co.uk: New Shop Feature and High-Performance Tyre Models16.3.2018 17:11 | Tiedote
Each year, summer trade means great challenges for car garages and tyre dealers. As a result and at just the right time, Yourtyres.co.uk, the online trade customer shop by Europe’s leading online tyre dealer Delticom, is introducing a new feature intended to make the daily work of the shop’s customers easier: An advice mode is available from now on at Yourtyres.co.uk. When changing from the purchasing to the sales view, the individual end customer prices are displayed instead of the actual purchase prices. In order to use this feature, users of Yourtyres.co.uk simply have to insert their individual markups for the different item groups. From the markup and the purchase price, the online shop automatically calculates the personal end customer price. The usual purchasing view is also still available. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005448/en/ An advice mode immediately helps trade customers use the full pot
Available Now: The Smartphone Made for the Way We Communicate Today, the Galaxy S9 and S9+16.3.2018 15:00 | Tiedote
Samsung Electronics America, Inc. announced that the new, award-winning Galaxy S9 and Galaxy S9+, which have been recognized by smartphone reviewers worldwide for their best-in-class display, design and camera, are now available for purchase at U.S. wireless network providers and retail stores. The phones come in three colors: Midnight Black, Coral Blue, and the new Lilac Purple. The Galaxy S9 has a suggested retail price of $719.99, while the Galaxy S9+ is available for $839.99. Both unlocked and carrier versions of the Galaxy S9 and Galaxy S9+ are also available for purchase on Samsung.com. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005175/en/ Designed for the way we communicate today, Samsung's new Galaxy S9 and Galaxy S9+ are available in the U.S. at wireless network providers, retailers and on Samsung.com. (Photo: Business Wire) “The Galaxy S9 and S9+ are designed for the visual and social generation—the consum
AccelStor All-Flash Solutions Unlock Data Possibilities for AI and Cloud16.3.2018 12:00 | Tiedote
AccelStor, an innovative all-flash array (AFA) provider for the big data era, is excited to announce its participation in the upcoming Cloud Expo Europe, taking place from March 21 to 22 at Booth C1850 in the ExCel London exhibition centre. Besides presenting latest all-flash storage solutions breaking through performance and availability barriers for artificial intelligence (AI), virtualization and private cloud, AccelStor will present a live demonstration of its new generation NeoSapphire high availability models, one of the highlights not to be missed this year. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005010/en/ AccelStor's new generation NeoSapphire High Availability all-flash array AccelStor NeoSapphire all-flash arrays are highly integrated with virtualization and private cloud platforms, supporting VMware vSphere and OpenStack Cinder. NeoSapphire’s “high availability” series features symmetric active-activ
CONQUEST Group Announced the Expansion of its Asset Management Business with the Appointment of Philippe Taillardat to the Role of Director16.3.2018 12:00 | Tiedote
Philippe Taillardat brings to CONQUEST over 25 years of Asset Management and Investment Banking experience, primarily in principal investing, financial advisory, equity and debt financing across global infrastructure and sustainable energy sectors. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005030/en/ Philippe Taillardat (Photo: CONQUEST Group) Philippe was most recently Co-Head of Infrastructure Investments Europe at First State Investments, which he helped transform into one of the leading billion+ European infrastructure fund manager in core / core+ strategies. Earlier in his career, Philippe held various senior banker and investment roles at Amundi, Credit Agricole CIB, Credit Suisse, AXA and BNP Paribas. Frédéric Palanque, Managing Director of CONQUEST Group, said, "We are delighted to welcome such a recognized professional. CONQUEST is trusted for providing value-added advice in complex and highly confidential
Westinghouse Completes First Major Decommissioning Work at a Nordic Commercial Nuclear Reactor16.3.2018 11:45 | Tiedote
Westinghouse Electric Company announced today that it has completed a major decommissioning project at the former Barsebäck nuclear power plant in Skåne, Sweden. Barsebäck Unit 2 ceased operation in 2005 and decommissioning work began in August 2016. Westinghouse’s scope of work included the underwater segmentation and packaging of the reactor vessel internals, as well as the upfront engineering studies and equipment manufacturing and qualification. “Westinghouse is proud to deliver this major decommissioning project on time and on budget,” said Yves Brachet, Westinghouse senior vice president, Global Decommissioning, Decontamination, Remediation and Waste Management. “Our global expertise in this area will help our customers in the Nordic region to safely manage a variety of end-of-life opportunities for commercial nuclear power plants.” Leadership at Barsebäck Kraft AB (BKAB) is equally satisfied with this successful initial step of the first dismantling of a commercial nuclear power
Lighting Manufacturer LTS Licht & Leuchten, Part of the Fargerhult Group, to Offer Selected Spot- & Downlights with Seoul Semiconductor’s SunLike Series Natural Spectrum LEDs16.3.2018 11:02 | Tiedote
Seoul Semiconductor, a global innovator of LED products and technology, announced that its SunLike Series natural spectrum LEDs, which implement light closest to the spectrum of natural sunlight, has been adopted for selected luminaires of LTS Licht & Leuchten GmbH, a German manufacturer of high-quality luminaires for hospitality, retail, and office applications. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005206/en/ LTS Jett 100 spotlights equipped with SunLike LED technology (Photo: Business Wire) LTS has adopted SunLike natural spectrum LEDs for selected products, including the Jett 100 and CSA 60 spotlights. A series of spotlights with a discreet and individual appearance, and clear, straightforward design lines, Jett spotlights harmoniously blend in with any type of retail application. The high color rendering and superior luminous intensity of these spotlights enable lighting designers to achieve accentuated ar
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