Business Wire

ERYTECH Completes Patient Enrollment in Phase 2 Trial of eryaspase (GRASPA®) for Pancreatic Cancer

Del

Regulatory News:

ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), a French biopharmaceutical company developing ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, today announced the final patient has been enrolled in its Phase 2 trial of eryaspase, also known as ERY-ASP or GRASPA®, for the treatment of pancreatic cancer.

The multicenter, randomized Phase 2 trial is evaluating eryaspase as a second-line treatment of patients with metastatic pancreatic cancer. In the study conducted in France, eryaspase was added to the standard of care (currently Gemcitabine or FOLFOX regimen) and then compared to the standard of care alone in a 2-to-1 randomization. The primary endpoint of the trial is progression-free survival (PFS) at four months.

The trial has completed enrollment of 139 patients and we expect to report primary results from this trial by early 2017.

“The Phase 2 trial of eryaspase for pancreatic cancer is, to our knowledge, the largest cohort of solid tumor patients treated with an asparaginase-based product to date,” said Gil Beyen, Chairman and CEO of ERYTECH. “Previously, deprivation of asparagine has shown to limit growth of pancreatic and other solid tumors in preclinical models, but clinical proof of concept has not yet been established. We believe a positive efficacy signal in this trial could open a potentially large application area for asparagine depletion in certain solid tumors.”

About pancreatic cancer:

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year there are about 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10% and is currently the fourth most common cause of cancer death in the EU for men and women. Pancreatic cancer could be a suitable indication for eryaspase because it involves a large proportion of tumors that are believed to be sensitive to asparagine depletion, allowing it to potentially have an impact.

About ERYTECH and eryaspase (ERY-ASP/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 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 filed for European Marketing Authorization for its lead product candidate, eryaspase, also known as ERY-ASP or under the trade name GRASPA®, following positive efficacy and safety results from its completed Phase 2/3 pivotal clinical trial in Europe in children and adults with relapsed or refractory ALL. ERYTECH also has an ongoing Phase 1 clinical trial of eryaspase in the United States in adults with newly diagnosed ALL, and a Phase 2b clinical trial in Europe in elderly patients with newly diagnosed AML, each in combination with chemotherapy.

Eryaspase 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 eryaspase (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 eryaspase 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 eryaspase for the treatment of ALL, AML and pancreatic 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.

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 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 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
+33 4 78 74 44 38
investors@erytech.com
Gil Beyen, Chairman and CEO
Eric Soyer, CFO and COO
or
The Ruth Group
Investor relations
Lee Roth, +1 646-536-7012
lroth@theruthgroup.com
or
Media relations
Kirsten Thomas, +1 508-280-6592
kthomas@theruthgroup.com
or
NewCap
+33 1 44 71 98 52
erytech@newcap.eu
Julien Perez, Investor relations
Nicolas Merigeau, Media relations

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 and Chi-Med’s Savolitinib Shows Encouraging Clinical Activity in 2nd-Line EGFR Mutation-positive Lung Cancer with MET-amplification16.10.2017 22:00Pressemelding

AstraZeneca and its partner Chi-Med today presented preliminary safety and clinical activity of savolitinib when given in combination with either Tagrisso (osimertinib) or Iressa (gefitinib) in two Phase Ib trials conducted in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) with MET-amplification who had progressed following 1st-line treatment with an EGFR inhibitor.1,2 In both trials, the addition of savolitinib (600mg, once daily), an investigational selective inhibitor of c-MET (mesenchymal epithelial transition factor) receptor tyrosine kinase, to osimertinib (80mg, once daily) or gefitinib (250mg, once daily) demonstrated preliminary anti-tumour activity. The data were shared in two oral presentations at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan, 15-18 Oc

Orlando Melbourne Int’l (MLB) Lands Largest FAA Grant in Its History16.10.2017 21:34Pressemelding

When Air Force One landed at Orlando Melbourne International Airport (MLB) in February, Airport Executive Director Greg Donovan took advantage of the opportunity and advised the president of the United States that his 747-200 just landed on a commercial runway officially rated ‘poor’ in aviation terms. That’s going to change, thanks to an $18,132,588 FAA grant announced by U.S. Secretary of Transportation Elaine Chao today. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171016006292/en/ Greg Donovan, A.A.E. (Photo: Business Wire) “We asked for, and received, tremendous support from the Florida congressional delegation,” said Jack L. Ryals, chairman of the Melbourne Airport Authority. “We are deeply grateful to Congressman Posey, Senator Nelson and Senator Rubio for their advocacy on this critic

Colombia Selects IDEMIA to Upgrade Its Identification and Civil Registry Platform16.10.2017 14:34Pressemelding

IDEMIA, the global leader in trusted identities for an increasingly digital world, has been selected by the National Civil Registry of Colombia (Registraduría Nacional del Estado Civil de Colombia – RNEC 1 ) to update the identification and civil registry platform. This platform is the trusted repository of citizens’ biometric and alphanumeric data and ensures the uniqueness of identities. IDEMIA (formerly known as OT-Morpho) has worked with the RNEC since the beginning of this project and has constantly supported the successive improvements of the solution. In 2017, when in need to strengthen the platform in order to offer new services to the government and to the population while maintaining a high level of security and satisfaction of the users, RNEC decided to pursue its partnership with IDEMIA. Through this new contract, IDEMIA will e

ATB Financial Goes-Live on Murex’s SaaS Solution16.10.2017 14:00Pressemelding

Sibos - Murex, a global leader in trading, risk management and processing solutions, is pleased to announce the successful launch of the MX.3 SaaS solution at ATB Financial. MUREX SaaS is a managed services offering for the MX.3 platform, encompassing infrastructure and application management. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171016005092/en/ ATB pursued this initiative in order to create a simple yet comprehensive foreign exchange experience for their customers. In addition to the customer benefit, ATB was also able to rationalize their IT landscape, broaden the scope of financial instruments they provide on their digital platform, and prepare for a large volume increase in their trading activities. Due to the strength of the solution’s risk management capabilities, extensive asset class coverage, and the ra

Leave a review on print24.com and win a VW up!16.10.2017 13:59Pressemelding

The online print shop UNITEDPRINT SE, owner of renowned brands including print24.com, is asking its customers for their opinions on the company’s products and services. In return for their views, customers will receive vouchers and be entered into a prize draw. The online print shop is offering one voucher for every review submitted across various portals. The vouchers – worth up to €25.00 and valid until 31 March 2018 – will be subject to a minimum order amount (product price inc. VAT, not including delivery) of €250.00 per voucher. All reviews received up to 31 December 2017 will be eligible, regardless of length and content. You can learn more about the review campaign at https://print24.com/rate/ But not only that, print24.com is also giving every reviewer the chance to win a brand-new VW up! Ali Jason Bazooband, Managing Director for Innovation/Marketing at print24.com,

Bentley Systems Announces Winners of 2017 Be Inspired Awards16.10.2017 13:52Pressemelding

The Year in Infrastructure 2017 Conference – Bentley Systems, Incorporated, a leading global provider of comprehensive software solutions for advancing infrastructure, has announced the winners of the 2017 Be Inspired Awards. The annual awards program honors the extraordinary work of Bentley users advancing the world’s infrastructure. At a ceremony and gala at their Year in Infrastructure 2017 Conference, Bentley acknowledged 17 Be Inspired Awards winners and six Special Recognition Awards winners. The Year in Infrastructure Conference is Bentley’s annual global gathering of leading professionals in the world of infrastructure design, construction, and operations. In addition to thought-provoking keynotes, technology demonstrations, industry forums, and panel discussions, the agenda included presentations by finalists in the Be Inspired Awards program, culminating in the selection of t

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

Besøk vårt presserom