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NewLink Genetics Launches Phase 3 Clinical Trial Of Algenpantucel-L Immunotherapy In Patients With Borderline Resectable Or Locally Advanced Unresectable Pancreatic Cancer

About the Phase 3 Study

This trial is an open-label, randomized, controlled, multi-center Phase 3 clinical trial, evaluating patients with borderline resectable or locally advanced unresectable pancreatic cancer. The primary endpoint of the clinical trial is overall survival, with secondary endpoints of progression-free survival, safety, toxicity and immunological responses.  The study plans to enroll up to 280 patients. Standard-of-care regimens for patients with borderline resectable or locally advanced unresectable pancreatic cancer patients include FOLFIRINOX (an abbreviation for a chemotherapy combination that includes the drugs leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin). In the Phase 3 clinical trial, half of the patients will receive FOLFIRINOX with algenpantucel-L and the remainder will receive FOLFIRINOX without algenpantucel-L.

About Pancreatic Cancer

The American Cancer Society estimates that approximately 44,030 new cases of pancreatic cancer were diagnosed in the United States in 2011.  Pancreatic cancer has generally been recognized as an aggressive form of cancer with non-specific initial symptoms, making it difficult to diagnose at an early stage.  Due to the difficulty in diagnosis and the aggressive nature of this cancer, the National Cancer Institute estimates a 96% mortality rate is associated with this disease, and the American Cancer Society estimates one-year and five-year overall survival rates of about 24% and 5%, respectively.

Pancreatic cancer can generally be divided into three broad categories: (1) local disease, in which the cancer is confined to the pancreas and can be removed surgically, which is called resection; (2) locally advanced disease, in which the cancer has spread locally and may or may not be eligible for resection because it has invaded tissues that should not be removed, such as key nerves and arteries; and (3) metastatic disease, in which the tumor has spread beyond the region of the pancreas.

About NewLink Genetics Corporation

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