Business Wire

ERYTECH Reports Top-line Results of Phase 2b Study of Eryaspase for the Treatment of AML

Jaa

Regulatory News:

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

Password: 6983889

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.

Forward-looking information

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.

Contact information

ERYTECH
Naomi Eichenbaum
Director of Investor Relations
+33 4 78 74 44 38
+1 917 312 5151
naomi.eichenbaum@erytech.com
or
The Ruth Group
Lee Roth
Investor relations
+1 646 536 7012
lroth@theruthgroup.com
or
Kirsten Thomas
Media relations
+1 508 280 6592
kthomas@theruthgroup.com
or
NewCap
Julien Perez
Investor relations
or
Nicolas Merigeau
Media relations
+33 1 44 71 98 52
erytech@newcap.eu

Tietoja julkaisijasta

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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Afton Chemical’s S$380 Million Phase II Expansion of Its Jurong Island Plant is Now Complete20.9.2018 23:30Tiedote

Afton Chemical Corporation, a global leader in the lubricant and fuel additive market, today announced the completion of the Phase II expansion of its Chemical Additive Manufacturing Facility in Jurong Island, Singapore. This milestone was marked by a special visit from Singapore’s Minister for Trade & Industry Mr. Chan Chun Sing, who also made a speech and toured the facility. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920005903/en/ Afton Chemical Corporation – Singapore Chemical Additive Manufacturing Facility Phase II Expansion (Photo: Business Wire) As a wholly owned subsidiary of NewMarket Corporation (NYSE: NEU), Afton has been a leading player in the lubricant and fuel additive marketplace for over 90 years. The company was founded on a Passion for Solutions® and has maintained a focus on customizing commercial and industrial solutions that meet customer needs. Afton begun its Singapore manufacturing operations

IFF Announces Pricing of €1,100,000,000 Senior Notes Offering20.9.2018 23:15Tiedote

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF), a leading innovator of sensorial experiences that move the world, today announced that it has priced its public offering of €300,000,000 aggregate principal amount of its 0.500% senior notes due 2021 and €800,000,000 aggregate principal amount of its 1.800% senior notes due 2026. IFF intends to use the net proceeds from the offering to pay a portion of the consideration for the previously announced merger with Frutarom Industries Ltd. and to pay related fees and expenses. IFF anticipates that the offering will close on September 25, 2018, subject to customary closing conditions. The offering is not contingent upon the consummation of the merger. If the closing of the merger has not occurred on or prior to February 7, 2019, or, if prior to such date, the merger agreement with Frutarom is terminated, IFF will be required to redeem all of the notes on the special mandatory redemption date at a redem

Pierre Fabre Receives EU Approval for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in Adult Patients with Advanced BRAF-Mutant Melanoma20.9.2018 20:21Tiedote

Pierre Fabre today announced that the European Commission (EC) has granted marketing authorisation for the combination of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.1,2 The EC decision is applicable to all 28 European Union (EU) member states plus Liechtenstein, Iceland and Norway. "We are extremely pleased that European patients with advanced BRAF-mutant melanoma will now have the combination of BRAFTOVI and MEKTOVI as a new treatment option”, said Frédéric Duchesne, President & CEO of the Pierre Fabre Pharmaceuticals Division. “All of us at Pierre Fabre are driven to make a real difference for patients. Bringing more than 30 years of oncology experience and our heritage in dermatology to our partnership with Array BioPharma, we have been able to harness our expertise in order to help men and women living with this devastating disease. Today’s

Clothesource Report Shows Retail Sales Aren’t Falling or Moving Online: Management’s Let Itself Get Misguided20.9.2018 20:19Tiedote

According to a new Clothesource report, “The Emperors’ Clothes” retail sales aren’t falling, and they’re not leaving physical stores. Both the UK’s Office of National Statistics and the US Bureau of the Census report higher retail sales than ever – with sales in physical stores still growing every year. Retailers just need to rely on their own customer understanding, recapture their self-confidence, and rediscover their traditional frugality. Among recent front-page stories have been Sears in the US hinting it’s about to go under and profits at Britain’s John Lewis falling 99%. But the well run clothing retailers are prospering. Primark goes from strength to strength: the biggest clothing specialists on either side of the Atlantic (Inditex and TJX) have just upped their sales and profit forecasts. So it’s not about consumer purchasing: The main problem lies with management, says Clothesource CEO Mike Flanagan in a new report “The Emperors’ Clothes”. They’ve lost touch with their custom

BCW Names Latin America Market Leaders20.9.2018 19:23Tiedote

BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced the appointment of market leaders in Latin America who will be responsible for business growth, client satisfaction and talent development. All market leaders report to Francisco Carvalho, President, Latin America, BCW. “BCW has a dominant presence in Latin America, thanks to Burson-Marsteller’s 40-year-history and expansive footprint across the region and Cohn & Wolfe’s strength in Brazil and Mexico,” said Carvalho. “This team has unmatched market knowledge, strong client relationships and deep commitment to talent, all of which is critical for our continued success in the region. Those strengths, together with our industry-leading expertise in delivering digitally driven integrated communications programs, make BCW a powerful partner for our clients.” All of BCW’s Latin America market leaders have been drawn from the legacy Burson-Marsteller organization and had been leading their respective markets, e

NavVis Achieves Breakthough 6D SLAM Indoor LiDAR Mapping With Velodyne’s 3D LiDAR Sensor20.9.2018 17:43Tiedote

On April 18th, 2018, NavVis released their M6, a fully-integrated, cart-based system designed for large-scale indoor mapping. The M6 utilizes VLP-16 sensors by Velodyne LiDAR, Inc., which allows it to produce a 3D map of the surrounding environment. Six cameras capture 360° immersive imagery and photorealistic point-clouds, resulting in high-resolution mapped images. NavVis developed this product in response to their customers’ request for a more versatile and sophisticated system which could be used effectively with uneven terrain. In addition to AEC professionals, construction companies and manufacturers can also draw benefits from the higher data quality provided by this enhanced innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920005560/en/ NavVis M6 is a fully-integrated, cart-based system designed for large-scale indoor mapping. (Photo: Business Wire) The M6 was developed by NavVis after customers requeste

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