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NewLink Initiates Pivotal Phase 3 Clinical Trial of HyperAcute(R)-Pancreas Immunotherapy for Resected Pancreatic Cancer
Date:5/27/2010

AMES, Iowa, May 27 /PRNewswire/ -- NewLink Genetics Corporation announced today treatment of the first patient in a nationwide Phase 3 clinical trial of its HyperAcute®-Pancreas cancer immunotherapy for patients who have successfully undergone pancreatic surgical resection.

"This pivotal study represents one of the largest Phase 3 clinical trials of immunotherapy ever conducted for pancreatic cancer in the United States," said Charles Link, M.D., chairman and chief executive officer of NewLink Genetics Corporation. "Our HyperAcute-Pancreas immunotherapy is unique from other approaches in that it is designed to trigger a powerful immune response to cancer cells similar to the hyperacute reactions that occur following xenotransplants – when tissues from lower animals are transplanted into humans."

The study will enroll approximately 700 previously untreated patients with Stage I or II surgically-resected cancer of the pancreas who have no visible disease detectable by a CT scan. Patients will be randomly assigned to receive the current standard of care, either Gemcitabine alone or Gemcitabine +5-FU and radiation with or without HyperAcute-Pancreas immunotherapy at about 50 major medical centers. Patients will be treated with adjuvant therapy for approximately six months and followed with periodic imaging for recurrence for five years. The primary objective is overall survival and secondary endpoints include disease-free survival, safety/toxicity and immunological responses.

"Patients with pancreatic cancer have very limited treatment options and a poor prognosis," said William Hawkins, M.D., associate professor, Hepatobiliary, Pancreatic and Gastrointestinal Surgery, W
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SOURCE NewLink Genetics
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