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Oct. 10, 2012 /PRNewswire/ -- NewLink Genetics Corporation (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 a promising clinical trial to offer patients with this devastating disease," commented Dr.
Nick Vahanian, Chief Medical Officer of NewLink Genetics. "We have more than 70 major cancer centers currently enrolling patients in our ongoing Phase 3 trial for resected pancreatic cancer patients. We believe these relationships will enable us to efficiently implement this new Phase 3 clinical trial, since the majority of locally advanced patients are evaluated at the same centers as the resectable patients."
NewLink's algenpantucel-L immunotherapy product candidate consists of a group of two allogeneic pancreatic cancer tumor cell lines that were modified to express Alpha-Gal. These cell lines were chosen to provide a broad coverage of pancreatic cancer antigens. Each of the modified cell lines is grown in large cultures, harvested, irradiated and packaged. Approximately 150 million cells of each HyperAcute Pancreas cell line are given by intradermal injection with each treatment.