NewLink Genetics Corporation has announced that additional data from its Phase 2 clinical trial of the company's investigational HyperAcute® Pancreas cancer immunotherapy will be presented during a poster session at the American Society of Clinical Oncology 2011 Gastrointestinal Cancers Symposium in San Francisco, California. A summary of the poster is below.
Title: Effect of the addition of algenpantucel-L immunotherapy to standard adjuvant therapy on survival in patients with resected pancreas cancer
• General Poster Session B, Friday January 21, 2011, 11:45 AM - 1:15 PM Pacific Time
• Abstract # 236, (poster board A85)
• First Author: Dr. Jeffrey M. Hardacre, University Hospitals Case Medical Center, Cleveland, Ohio
The open-label, non randomized, multicenter Phase 2 clinical trial included 70 patients with surgically resectable pancreatic cancer who received the HyperAcute Pancreas immunotherapy in combination with standard adjuvant chemotherapy. The primary objective of the study was disease-free survival at 12 months.
Based on positive data from this Phase 2 clinical trial, NewLink is currently enrolling a nationwide Phase 3 clinical trial of HyperAcute Pancreas cancer immunotherapy in patients who have successfully undergone pancreatic surgical resection. The U.S. Food and Drug Administration (FDA) has granted both Fast Track designation and Orphan Drug designation for this program.