ERYtech Pharma Completes Patient Enrollment In Phase 2 Trial Of Eryaspase (GRASPA) For Pancreatic Cancer
Primary data read-out from the trial expected by early 2017
Lyon (France), September 26, 2016 - ERYTECH Pharma (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(R), 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 ERY-ASP (GRASPA(R)): 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(R), 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 2 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(R)), 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(R) 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).
Lyon (France), September 26, 2016 - ERYTECH Pharma (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(R), 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 ERY-ASP (GRASPA(R)): 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(R), 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 2 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(R)), 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(R) 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).