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news.ERYTECH Pharma, the French biopharmaceutical company that develops innovative ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, has announced the enrollment of the first patient in its Phase II study with ERY-ASP in second line treatment of patients affected by pancreatic cancer.
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Three months after its authorization by the ANSM, the French authority for drug safety, a first patient has been enrolled.
Having already successfully completed a Phase I study in late stage pancreas cancer, in which the tolerability of ERY-ASP had been confirmed in this very fragile patient population, ERYTECH had decided earlier this year to continue the development of its lead product ERY-ASP in solid tumors by performing a Phase II study in second-line therapy for patients with progressive metastatic pancreas cancer.
In a study of about 90 patients, ERY-ASP in addition to the standard of care will be compared to the standard of care alone in a 2-to-1 randomization. The primary endpoint will be progression-free survival (PFS) at 4 months.
In Europe and the USA alone, every year about 125,000 patients are newly diagnosed with pancreatic cancer. With an overall 5 year survival of less than 10%, pancreas cancer is one of the most aggressive forms of cancer.
"New drugs for the second line treatment of pancreatic cancer are strongly needed. Starving the tumors in amino acid thanks to ERY-ASP is an innovative and promising approach. I am happy this study is started" says Professor Pascal Hammel, Principal investigator of the study, Department of Gastroenterology & Pancreatology at Hopital Beaujon (Clichy- France).
"The fast launch of this study is a good indicator of the great interest for our product by the physicians to meet this important medical need pancreas cancer represents. With our innovative asparaginase product, we hope to contribute to extending the toolbox for the treatment of patients affected by this terrible disease and by other solid tumor indications" adds Gil Beyen, Chairman & CEO of ERYTECH. "It is a very important step for ERYTECH to enter the solid tumor field".