NewLink Genetics Receives Special Protocol Assessment Approval from FDA for Pivotal Phase 3 Trial in Pancreatic Cancer

AMES, Iowa, Feb. 11 /PRNewswire/ -- NewLink Genetics Corporation announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for a pivotal Phase 3 trial of its HyperAcute immunotherapy in pancreatic cancer. Pancreatic cancer is highly lethal and is currently an area of very significant unmet medical need.  The SPA is a written agreement between NewLink as the trial sponsor and the FDA regarding the design, endpoints, and planned statistical analysis of a Phase 3 trial to be used in support of a Biologic License Application (BLA).

"NewLink has a broad platform of tumor specific immunotherapies based on its HyperAcute technology platform.  With the approval of this Special Protocol Assesment, we will be advancing the first of these into pivotal studies," said Dr. Charles Link, Chairman and Chief Executive Officer of NewLink Genetics Corporation.  "With the additional funding we raised in 2009, we are well positioned to launch the Phase 3 trial under this protocol in more than 50 major cancer centers."

About the Phase 3 Pancreatic Cancer Study

The Phase 3, multicenter, open label, controlled study will enroll up to 680 evaluable previously untreated patients with resected pancreatic cancer. The patients will be randomly assigned on a 1:1 basis to receive either the current standard of care, or the current standard of care plus the NewLink HyperAcute pancreatic cancer immunotherapy. Overall survival will be the primary endpoint, and the secondary endpoint will be disease free survival.

About the SPA

The SPA approval represents a binding agreement between NewLink as the sponsor and the FDA regarding the  design, endpoints and statistical analysis plan of the proposed study, and may not be changed unless the FDA determines that a substantial scientific issue essential to determining the safety or efficacy of the drug was identified after the testing began.

About NewLink Genetics Corporation

NewLink Genetics Corporation is a biopharmaceutical company applying innovative technologies to create new therapeutic agents for patients with cancer and infectious diseases.  Its products are designed to enhance the patient's immune system, enabling the body's immune cells to target diseased tissues.

SOURCE NewLink Genetics Corporation

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