ERYTECH to Present Full Results for Phase 2b Trial of eryaspase in Pancreatic Cancer at ESMO 2017
Regulatory News:
ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris - ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced that it will present the full data from its Phase 2b trial evaluating eryaspase for the treatment of metastatic pancreatic cancer at the upcoming European Society for Medical Oncology Annual Meeting, being held September 8 – 12, 2017 in Madrid, Spain.
Prof. Pascal Hammel, MD, PhD, gastroenterologist-oncologist at Beaujon Hospital and principal investigator of the trial, will present the full results of the Phase 2b study of eryaspase (GRASPA®), L-asparaginase encapsulated in red blood cells, in combination with chemotherapy for the treatment of second-line metastatic pancreatic cancer.
In March 2017, the company announced positive topline results from the open label, randomized, multicentre Phase 2b trial of 140 enrolled patients. The trial met its prespecified co-primary endpoints, with significant improvement observed in both progression-free survival (PFS) and overall survival (OS) in patients treated with eryaspase combined with chemotherapy compared to chemotherapy alone.
Abstracts from the ESMO 2017 Annual Meeting will be available online on the conference website beginning at 12:05 a.m. CEST on Thursday, August 31, 2017.
Poster Session and Presentation Details to Follow:
Poster Display: A Phase 2b of eryaspase in combination with gemcitabine or FOLFOX as second-line therapy in patients with metastatic pancreatic adenocarcinoma (NCT02195180)
| Poster: | #621PD | |||
| Lead Author: | Prof. Pascal Hammel, MD, PhD; Beaujon Hospital, France | |||
| Poster Session/Section: | Poster Display Session | |||
| Date: | Saturday, September 9 | |||
| Time: | 1:15 – 2:15 p.m. CEST | |||
| Location: | Hall 9, IFEMA - Feria de Madrid |
Poster Discussion Session:
| Discussant: | Prof. Stefano Cascinu, MD, PhD; Ancona, Italy | |||
| Date: | Monday, September 11 | |||
| Time: | 4:30 – 6:00 p.m. CEST | |||
| Location: | Cordoba Auditorium, IFEMA - Feria de Madrid |
Copies of the poster presentations will be available online September 9th, 2017, on ERYTECH’s website at www.erytech.com.
ESMO Investor & Analyst Event and Webcast: Erytech will host an investor and analyst event on Monday, September 11th at 6:15 p.m. CEST. Erytech management and principal investigator, Prof. Pascal Hammel will present and discuss the full dataset from the Phase 2b trial of eryaspase in metastatic pancreatic cancer. The Company will also highlight its ERYCAPS® technology and provide an overview of its lead eryaspase program and pipeline programs.
| Event: | Erytech Investor & Analyst Reception | |||
| Date: | Monday, September 11 | |||
| Time: | 6:15 – 8:00 p.m. CEST | |||
| Location: | Nuevo Boston Hotel, Madrid |
Pre-registration for the event is required. To RSVP, please contact Janhavi Mohite at jmohite@theruthgroup.com.
For those unable to attend, a live webcast will be accessible at the start of the event (06:30pm) and available for replay on the investor relations page of the Erytech corporate website at www.erytech.com.
The call can be followed via the following teleconferencing numbers:
| USA: +1 6467224907 | United-Kingdom: +44 2030432440 | |||
| Switzerland: +41 225809022 | Germany: +49 69222229031 | |||
| France: +33 172001510 | Belgium: +32 24029640 | |||
| Sweden: +46 850334664 | Finland : +358 942599700 | |||
| Netherlands: +31 107138194 |
Confirmation Code: 83328551#
The webcast can be followed live online via the link:
http://www.anywhereconference.com?UserAudioMode=DATA&Name=&Conference=135310579&PIN=83328551
Following the live call, a replay will be available for 90 days. To listen to the replay, please dial:
| USA: +1 877 64 230 18 |
| United-Kingdom: +44(0) 2033679460 |
| France: +33(0)1 72 00 15 00 |
Confirmation Code: 310579#
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 treatment of blood cancers, including acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), by depriving tumors of nutrients necessary for their survival. ERYTECH plans to pursue regulatory approvals for its lead product candidate, eryaspase, also known under the trade name GRASPA®, having achieved 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. ERYTECH believes that eryaspase also has the potential as a treatment approach in solid tumors and has completed a Phase 1 study and a 140-patient Phase 2 clinical trial in France, evaluating eryaspase in patients with second line metastatic pancreatic cancer.
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. 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 two other product candidates, that focus on using encapsulated enzymes to target cancer metabolism and induce tumor starvation. The company is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies and enzyme replacement therapies.
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 press release contains forward-looking statements, forecasts and estimates with respect to the clinical development plans, 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.
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Contact information
ERYTECH
Gil Beyen, +33 4 78 74 44 38
Chairman
and CEO
or
Eric Soyer, +33 4 78 74 44 38
CFO and
COO
investors@erytech.com
or
The
Ruth Group
Lee Roth, +1 646 536 7012
Investor
relations
lroth@theruthgroup.com
or
Kirsten
Thomas, +1 508 280 6592
Media relations
kthomas@theruthgroup.com
or
NewCap
Julien
Perez, +33 1 44 71 98 52
Investor relations
or
Nicolas
Merigeau, +33 1 44 71 98 52
Media relations
erytech@newcap.eu
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