ERYTECH to Present Preclinical and Clinical Data on Use of Eryaspase in ALL and AML at EHA 2018
LYON, France, June 15, 2018 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext:ERYP) (Nasdaq:ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced that it will present preclinical data on the enzymatic activity of eryaspase (GRASPA®) for the treatment of relapsed acute lymphoblastic leukemia (ALL) and results of its Phase 2b clinical trial evaluating eryaspase (GRASPA®) for the treatment of acute myeloid leukemia (AML) at the European Hematology Association (EHA) Congress, being held June 14-17, 2018 in Stockholm, Sweden.
The preclinical eryaspase data will be presented during Poster Session I by Dr. Karine Aguera, ERYTECH's R&D Project Leader.
|Poster Session: Preclinical Demonstration of Intracellular Activity of Asparaginase Encapsulated in Red Blood Cells Both in the Absence and in the Presence of Neutralizing Anti-Asparaginase Antibodies|
|Lead Author:||Karine Aguera|
|Poster Session:||Poster Session I|
|Date:||Friday, June 15, 2018|
|Time:||5:30 p.m. - 7:00 p.m. (CEST)|
|In these in vivo and in vitro preclinical studies, eryaspase was effective in reducing L-asparagine (ASN) levels, both in the presence and absence of neutralizing anti-asparaginase antibodies (nAbs). The preclinical findings, confirmed in additional in vitro experiments with eryaspase, support the theory that intra-cellular asparaginase activity may be responsible for the sustained effect on ASN reduction and can provide a more effective approach for the delivery of the L-asparaginase enzyme in patients with ALL, particularly in patients who have developed nAbs.|
|The AML Phase 2b trial data will be presented during Poster Session II by Dr. Mathilde Hunault of Centre Hospitalier Universitaire (CHU) d'Angers, France.|
|Poster Session: A Phase 2b of Eryaspase in Combination with Low-Dose Cytarabine as First-Line Therapy in Elderly Patients with Acute Myeloid Leukemia (ENFORCE - NCT01810705)|
|Lead Author:||Xavier Thomas|
|Poster Session:||Poster Session II|
|Date:||Saturday, June 16, 2018|
|Time:||5:30 p.m. - 7:00 p.m. (CEST)|
The Phase 2b trial to evaluate the efficacy of eryaspase in elderly AML patients did not meet its primary endpoint to improve overall survival in this difficult-to-treat patient population. Patient selection is likely the most important factor, with enrolled patients remaining only briefly on treatment and unable to achieve a potential drug effect. Individualized risk stratification based on multi-parameter assessment tools and co-morbidity burden should be considered for older adults with AML participating in clinical trials.
ERYTECH also has an abstract on the incidence of Venous Thromboembolism (VTE) in 125 ALL patients, treated in five studies.
Abstract: Venous Thromboembolism in Patients with Acute Lymphoblastic Leukemia (ALL) Treated with Eryaspase (L-Asparaginase Encapsulated in Red Blood Cells)
|Lead Author:||Yves Bertrand|
|Location:||EHA Website Abstracts|
The findings of this study show that the risk of VTE with eryaspase treatment in ALL patients was low and observed primarily in adults. The low incidence of these events may be related to decreased incidence of impaired coagulation parameters.
About ERYTECH: 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 altered amino acid metabolism of cancer cells, 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 pediatric acute lymphoblastic leukemia (ALL), but side effects limit treatment compliance, especially in adults and patients with weak performance status.
Eryaspase demonstrated positive efficacy and safety results in various clinical trials in ALL, including in a Phase 2 study in patients over 55 years of age and in a Phase 2/3 trial in relapsed or refractory ALL patients, as well as in pancreatic cancer, where it achieved positive results in a Phase 2b trial of second-line treatment of patients with metastatic pancreatic cancer. ERYTECH is preparing for the launch of a pivotal Phase 3 clinical trial in second line pancreatic cancer and Phase 2 trials in first line pancreatic cancer and triple-negative breast cancer.
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 erymethionase, methionine-Y-lyase encapsulated in red blood cells, to target cancer cells' amino acid 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.
Director Investor Relations
|+33 4 78 74 44 38
+1 917 312 5151
|+33 1 44 71 98 52
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. All statements contained in this press release other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding the potential of ERYTECH's product pipeline, its clinical development and regulatory plans for eryaspase, the timing of ERYTECH's clinical studies and trials and announcements of data from those studies and trials, and the contents and timing of decisions by the FDA and EMA regarding ERYTECH's product candidates. 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. Further description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the French Autorité des Marchés Financiers (AMF), the Company's Securities and Exchange Commission (SEC) filings and reports, including in the Company's 2017 Document de Référence filed with the AMF in April 2018 and in the Company's Annual Report on Form 20-F filed with the SEC on April 24, 2018, as amended on May 23, 2018, and future filings and reports by the Company. 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
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Erytech Pharma S.A. via Globenewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
Infovista Expands 5G Network Testing and Planning Capabilities20.2.2019 15:00:00 | Pressemelding
ASHBURN, Va., Feb. 20, 2019 (GLOBE NEWSWIRE) -- Infovista, the leader in modern network performance, today announced new versions of its TEMS Investigation and Planet solutions. With this announcement, Infovista is the only vendor offering the complete 5G portfolio comprising full network planning and testing in a single, integrated platform. Infovista is now uniquely positioned to help mobile network operators roll out 5G NR networks by including the ability to provide integrated Geodata, 5G Planning and Network Testing capabilities. Tweet This: @Infovista expands 5G network testing and planning capabilities, offering complete 5G portfolio in a single, integrated platform: https://bit.ly/2Nm8Rup With the new release of TEMS Investigation, Infovista introduces support for 5G smartphones based on the Qualcomm X50 chipset. With initial support of Qualcomm based devices and plans for agnostic device support, customers will be able to choose between different test devices and scanners to s
Reminder: Constellation Brands to Present at Consumer Analyst Group of New York Conference, February 20, 201920.2.2019 14:30:00 | Pressemelding
VICTOR, N.Y., Feb. 20, 2019 (GLOBE NEWSWIRE) -- Constellation Brands, Inc. (NYSE: STZ and STZ.B), a leading beverage alcohol company, reiterates that Bill Newlands, president and chief operating officer, and David Klein, chief financial officer, will present at the Consumer Analyst Group of New York (CAGNY) conference on Wednesday, February 20, 2019, at the Boca Raton Resort & Club in Florida. The presentation is scheduled to begin at 3:00 p.m. EST and is expected to cover the company’s strategic business activities, including a discussion on portfolio strategy; financial and operational performance; and outlook for the future, including a discussion on the accounting methodology and potential impact on fourth quarter fiscal year 2019 non-cash equity in earnings from the company’s Canopy Growth investment. A live audio webcast of the presentation can be accessed on the company’s website at www.cbrands.com by following the instructions in the “Investors” section under “Events & Presenta
Fortuna provides construction update at its Lindero gold project in Argentina20.2.2019 11:00:00 | Pressemelding
VANCOUVER, British Columbia, Feb. 20, 2019 (GLOBE NEWSWIRE) -- Fortuna Silver Mines Inc. (NYSE: FSM) (TSX: FVI) is pleased to provide an update on construction activities at its 100 percent owned Lindero gold Project located in the Province of Salta, Argentina. Following the cessation of unusually heavy rainfall in Salta Province in recent weeks, which resulted in damage to the road leading to the Lindero Project site (see Fortuna news release dated February 7, 2019), management is pleased to report that the road has been repaired and on February 18th the mobilization of personnel and materials to the project site resumed. Mr. Jorge A. Ganoza, President, CEO and Director, commented, “Abnormal rains and electrical thunder storms not seen in a decade in the region are impacting our construction activities and schedule projections. A large amount of the float in the construction schedule has been consumed due to a slow start and ramp-up in excavations at the leach pad and crushing plant,
DoubleVerify Acquires Digital Video Technology Company, Zentrick20.2.2019 09:00:00 | Pressemelding
Solving 30% breakage in video ad delivery NEW YORK and GHENT, Belgium, Feb. 20, 2019 (GLOBE NEWSWIRE) -- DoubleVerify, the leading independent provider of marketing measurement software and analytics, today announced that it has acquired Zentrick, a digital video technology company that provides middleware solutions to drive the seamless execution and performance of online video advertising for the world’s largest brands, platforms and publishers. The Zentrick engineering teams will continue to operate from offices in Ghent, Belgium. The transaction was completed as an all cash, all stock offer on February 15, 2019. Video advertising spend soared to $28 Billion in 2018. However, the ecosystem necessary to support the growth in video ad delivery has become highly fragmented. Today over 30% of video ads that are sold are unable to be delivered by publishers due to various forms of technical ‘breakage’ in the ad delivery chain – an issue that’s particularly acute in the key areas of mobil
ADC Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ADCT-402 (loncastuximab tesirine) and Ibrutinib in Patients with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma20.2.2019 07:00:00 | Pressemelding
Combination trial to evaluate safety and anti-tumor activity of agents that target B-cell cancers LAUSANNE, Switzerland, Feb. 20, 2019 (GLOBE NEWSWIRE) -- ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), today announced that the first patient has been dosed in a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-402 (loncastuximab tesirine) in combination with Pharmacyclics LLC’s ibrutinib in patients with advanced diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL). ADCT-402, an ADC designed to target and kill CD19-expressing malignant B-cells, is also being evaluated in an ongoing pivotal Phase II clinical trial in patients with relapsed or refractory (R/R) DLBCL and a Phase I clinical trial in combination with IMFINZI® (durvalumab) in patients with multiple types of R/R non-Hodgkin lymphoma. Ibrutinib, a sma
RedAwning Opens Up New Office in Palma de Mallorca, Spain To Offer Industry-Leading Distribution, Marketing + Reservations Services to European Property Managers20.2.2019 02:30:00 | Pressemelding
New Jetstream Team Office To Support RedAwning Group’s Expansion in Europe and Provide Comprehensive Support For International Clients Emeryville, California, Feb. 19, 2019 (GLOBE NEWSWIRE) -- RedAwning, the world’s largest collection of vacation properties, today announced that it has opened up an office in ParcBit, Palma de Mallorca, Spain to service the RedAwning Group’s growing portfolio of international vacation property managers and to offer RedAwning’s industry-leading distribution, marketing and reservation solutions to managers of alternative accommodations throughout Europe. RedAwning is a single point of entry for managers of single vacation homes and multi-unit boutique hotels, resorts, apart-hotels and corporate apartments to access the widest online travel network in the world, including Booking.com, Expedia, Airbnb, and HomeAway/VRBO, as well as a major travel metasearch sites including trivago, Holidu, HomeToGo and TripAdvisor. RedAwning is also integrated with Google H