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NewLink Genetics Reveals Positive Results From Its Phase-2 Immunotherapy Trial

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6/4/2012 9:12 AM ET

NewLink Genetics Corporation (NLNK: Quote) Monday revealed then results of its 0ne-year, two-year and three-year overall survival data from its Phase-2 HyperAcute Pancreas Immunotherapy trial.

The multi-institutional, open-label, dose-finding, Phase 2 trial evaluated the use of algenpantucel-L in addition to chemotherapy with chemoradiotherapy in the adjuvant setting for resected pancreatic cancer.

The company stated that the study results show 37%, 59% and 121% improvement in 1-, 2- and 3-year survival, respectively, as compared to standard-of-care.

The company stated that the primary endpoint of the study, 12-month disease free survival (DFS), was 62%. The median DFS was 14.1 months. Subgroup analysis showed that patients receiving 300 million cells/dose had a 12-month DFS of 81%, while those receiving 100 million cells/dose had a 12-month DFS of 51%.

The results of the trial revealed that the Overall 12-month survival was 86%. The predicted 12 month overall survival in our study was 63%. Subgroup analysis showed that patients receiving 300 million cells/dose had an overall 12-month survival of 96%, while those receiving 100 million cells/dose had an overall 12-month survival of 79%. Two-year overall survival in our study was 51% with a predicted survival of 32% and 3-year overall survival was 42% with a predicted survival of 19%.

NewLink Genetics further added that the HyperAcute Pancreas immunotherapy product candidate, also referred to as algenpantucel-L, demonstrated good tolerability and a favorable safety profile with no grade four adverse events considered attributable to the immunotherapy.

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by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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