ERYTECH Announces Publication of Two Articles Describing Clinical Results With ERY-ASP/GRASPA
20.10.2015 17:00 | Business Wire
ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, announces the publication of two peer-reviewed manuscripts describing clinical results obtained with ERY-ASP/GRASPA®.
The first article, published in the September 2015 issue of the American Journal of Hematology, entitled ”A Phase 2 study of L-asparaginase encapsulated in erythrocytes in elderly patients with Philadelphia chromosome negative acute lymphoblastic leukemia: the GRASPALL/GRAALL-SA2-2008 study” describes the results of a dose-escalating Phase 2 study, evaluating the safety and efficacy of GRASPA in thirty patients ≥ 55 years of age with newly diagnosed Philadelphia negative acute lymphoblastic leukemia (ALL). The study concludes that the addition of GRASPA to standard induction chemotherapy regimen, especially at the 100 IU/kg dose level, is feasible in elderly patients without excessive toxicity and associated with durable asparagine depletion.
The article can be found on-line at: http://www.ncbi.nlm.nih.gov/pubmed/26094614
The second article, published in the October 2015 issue of Pancreas, entitled “Asparagine Synthetase Expression and Phase I Study With L-Asparaginase Encapsulated in Red Blood Cells in Patients With Pancreatic Adenocarcinoma” evaluates the expression of asparagine synthetase (ASNS) in over 500 pancreatic cancer tumor biopsies and presents the results of a Phase 1 study in 12 patients with metastatic pancreatic cancer. 79.4% of tumor biopsies analyzed had no or low ASNS expression with high concordance between primary tumor and metastases. In the Phase 1 study, ERY-ASP was well tolerated and no dose limiting toxicities were identified.
The article can be found on-line at: http://www.ncbi.nlm.nih.gov/pubmed/26355551
Iman El-Hariry, Chief Medical Officer of ERYTECH, comments: “Both studies provide additional support for the potential use of our lead product candidate ERY-ASP/GRASPA in very difficult to treat patient populations. The use of asparaginase in elderly ALL patients and metastatic pancreatic cancer patients has been limited by excessive toxicity so far. The favorable safety profile observed with ERY-ASP in these patients provided support for our ongoing Phase 1 study in adult ALL in the United States, our ongoing Phase 2 studies in acute myeloid leukemia patients over 65 years of age and our ongoing Phase 2 study in metastatic pancreatic carcinoma.”
About ERYTECH and ERY-ASP (GRASPA®): www.erytech.com
Created 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 announced positive efficacy and safety results from its completed Phase 2/3 pivotal clinical trial in Europe with its lead product candidate, ERY-ASP, also known under the trade name GRASPA®, in children and adults with relapsed or refractory ALL. ERYTECH also has an ongoing Phase 1 clinical trial of ERY-ASP in the United States in adults with newly diagnosed ALL, and a Phase 2 clinical trial in Europe evaluating GRASPA as a first-line therapy for the treatment of elderly patients with AML, each in combination with chemotherapy.
ERY-ASP 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 ERY-ASP/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 ERY-ASP 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 ERY-ASP/GRASPA for the treatment of ALL, AML and pancreatic cancer. ERYTECH produces ERY-ASP 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 ERY-ASP for ALL and AML in Europe with Orphan Europe (Recordati Group), and for ALL in Israel with TEVA, who 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).
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 the 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 the 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.
Chairman and CEO
Tel: +33 4 78 74 44 38
Julien Perez / Emmanuel Huynh
Tel: +33 1 44 71 98 52
Om Business Wire
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
Out-of-this-World Science Project to be Featured as Keynote at SC17’s High Performance Computing Conference in Denver16.8.2017 13:00 | Pressemelding
Professor Philip Diamond, Director General of the international Square Kilometer Array (SKA) project, will be the keynote speaker at SC17, the International Conference for High Performance Computing, Networking, Storage and Analysis in Denver, Nov. 12-17. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005129/en/ SC17 Keynote Speaker Philip Diamond (Photo: Business Wire) SKA is an international collaboration to build the world’s largest radio telescope that will change our understanding of space as we know it. Professor Diamond, accompanied by Dr. Rosie Bolton, SKA Regional Centre Project Scientist, will take SC17 attendees around the globe and out into the deepest reaches of the observable universe as they describe the SKA’s international partnership that will map and study the e
Maxion Wheels to Feature Market Leading Commercial Vehicle Steel Wheels at COMTRANS 201716.8.2017 13:00 | Pressemelding
Maxion Wheels, the world’s largest wheel manufacturer, announced today its participation in the biennial COMTRANS / 17 International Commercial Vehicle Show held in Moscow, Russia from September 4 – 9, 2017, in Hall 15/ Stand 15-432. Customers and visitors to the Maxion Wheels exhibit will have the opportunity to learn more about the state-of-the-art commercial vehicle steel wheels that have supported the success of global original equipment manufacturers for almost 100 years. One of the key products on display will be the new 8.5” x 24” wheel for tubeless tire applications in Russia, the Middle East and Africa. The wheel boasts 15 percent less weight than the prior generation wheel, enhancing tire life and improving fuel efficiency. ABOUT MAXION WHEELS Maxion Wheels, a division of IOCHPE-MAXION S.A., is a leading wheel manufacturer for passenger cars,
Scientist.com Ranks No. 155 on the 2017 Inc. 5000 List of Fastest-Growing Companies16.8.2017 12:06 | Pressemelding
Scientist.com, the leading marketplace for outsourced scientific services, today announced that it ranked no. 155 on Inc. magazine’s 2017 List of the 5000 Fastest-Growing privately-owned companies in America, and it ranked no. 11 in the country in the Health category. The San Diego-based company builds private marketplaces that connect many of the world’s largest life science research organizations with a global network of thousands of research suppliers. “Using Scientist.com, research organizations of pharmaceutical companies, biotech start-ups and academic and research institutes can get near instant access to thousands of the latest research technologies and services,” stated Paul A. Stone, JD, Partner at 5AM Ventures, a Scientist.com investor. “The marketplace saves researchers time, reduces costs, promotes access to innovation and ensures regulatory compliance. Scientist.com is im
CMB Successfully Goes-Live on Murex’s MX.3 Platform16.8.2017 08:00 | Pressemelding
Murex, a global leader in trading, risk management and processing solutions, is pleased to announce the successful launch of the MX.3 platform at China Merchants Bank (CMB). As one of China’s largest commercial banks, CMB financial market department currently averages 8,000 trades per day with a portfolio of 320,000 live trades on MX.3. CMB decided to launch the project to implement an enterprise-wide solution for their capital markets teams based in Shenzhen and Shanghai. This was done in order to improve control over their end-to-end trading cycle from front-to-back through risk, streamline and automate their operations, and enable new business. Murex’s MX.3 platform was selected as it provided the functional, geographical and product coverage that was required by the bank. Covering Front Office, Processing, Finance, and Risk Management, MX.3 also provides VaR analytics across all asset
euNetworks Adds New High Density Fibre Network in Manchester16.8.2017 08:00 | Pressemelding
euNetworks, a provider of bandwidth services in Europe, today announced it has made further investment in Manchester in the United Kingdom, having built out a new high density fibre network covering over 40 route kilometres in the city. This follows initial expansion into Manchester’s MediaCityUK in May 2016, which supported euNetworks’ Media customer’s bandwidth needs, as well as enabling a seamless network experience from London through to Manchester and Dublin and onwards to Europe. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005067/en/ euNetworks Fibre in Manchester (Photo: Business Wire) This new network in Manchester city was designed for resilience, with fully diverse nodes. euNetworks undertook a combination of new construction and duct acquisition to complete this network
The Peninsula Classics Best of the Best Award for 2016 Awarded to 1954 Maserati A6GCS/53 Berlinetta by Pinin Farina16.8.2017 07:28 | Pressemelding
At a highly-anticipated private gathering during the famed Monterey Car Week, a 1954 Maserati A6GCS/53 Berlinetta by Pinin Farina, from the Monaco-based Destriero Collection, was named winner of the prestigious second-annual The Peninsula Classics Best of the Best Award . This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170816005384/en/ 1954 Maserati A6GCS/53 Berlinetta by Pinin Farina was named winner of the prestigious The Peninsula Classics Best of the Best Award. Photo Credit: Adam Swords Only four Berlinetta-bodied sports cars from Pinin Farina were ever produced, and this exquisite model is considered to be the best preserved, as it is the only one that retains its original chassis and body. Custom ordered by the Roman dealer of the marque, the sports car is
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom