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NewLink Genetics Announces Phase 3 Clinical Trial of algenpantucel-L Immunotherapy

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NewLink Genetics (NASDAQ: NLNK) announces launching of an open-label, randomized, multi-institutional Phase 3 study in patients with borderline resectable or locally advanced unresectable pancreatic cancer. The projected enrollment will be 280 subjects and patients will be randomized (1:1) to receive standard of care FOLFIRINOX plus or minus algenpantucel-L (HyperAcute®-Pancreas) immunotherapy. The primary endpoint of the study will be to evaluate overall survival.  Secondary objectives include evaluation of progression free survival and immunological response.

"We are excited to initiate an additional Phase 3 clinical trial for algenpantucel-L to potentially expand into a new indication for locally advanced pancreatic cancer. We have made significant progress in our Phase 3 trial with algenpantucel-L for resected pancreas cancer patients since its launch in May of 2010," commented Dr. Charles Link, Chief Executive Officer of NewLink. He added, "There is an enormous unmet need in the pancreatic cancer market for both resectable and unresectable patients. The successful expansion of algenpantucel-L into  a market segment for locally advanced disease would potentially more than double the patient population who might benefit from this immunotherapy treatment."

"We believe this new study will be favorably perceived by the clinicians as they will have

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