NewLink Genetics has reached a Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA) for a pivotal Phase III trial of its HyperAcute immunotherapy in pancreatic cancer.
The SPA allows for FDA approval in the case where an uncompleted Phase III trial’s design, clinical endpoints, and statistical analyses are still seen as acceptable for FDA approval.
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 III trial to be used in support of a biologic licence application.
NewLink Genetics chairman and CEO Dr Charles Link said that NewLink has a broad platform of tumour-specific immunotherapies based on its HyperAcute technology platform.
“With the additional funding we raised in 2009, we are well positioned to launch the Phase III trial under this protocol in more than 50 major cancer centres,” Link said.
The Phase III, multicentre, open-label controlled study will enroll up to 680 evaluable previously untreated patients with resected pancreatic cancer.
The primary endpoint is overall survival and the secondary endpoint will be disease-free survival.