AMES, Iowa, May 22, 2012 (GLOBE NEWSWIRE) — NewLink Genetics Corporation (Nasdaq:NLNK – News), today announced that Phase 2 data from its investigational HyperAcute(R) Pancreas immunotherapy clinical trial in surgically resected pancreas cancer patients will be presented at the 53rd Annual Meeting of the Society for Surgery of the Alimentary. The detailed results will be published in the Journal of Gastrointestinal Surgery. HyperAcute(R) Pancreas is currently being evaluated in a multi-institution, randomized, Phase 3 clinical trial under a Special Protocol Assessment with the FDA.

“The primary endpoint of this study was to evaluate disease free survival and this was achieved with an observed twelve month DFS of 62% and median DFS of 14.1 months,” commented the primary investigator Dr. Jeffrey M. Hardacre of the University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, OH and presenter of the study results. “In addition to successfully achieving the primary endpoint, we were particularly encouraged by both the favorable impact on overall survival and the anecdotal, yet provocative, observation that three patients who had relapsed after Algenpantucel-L treatment and were subsequently treated with a variety of second line therapies then obtained complete radiographic responses. Further, we are excited by the fact that all three of these patients’ complete responses have been durable with none recurring over the 6 to 36 months since their observed complete remissions.”

“It is gratifying to take another step forward in our mission to bring novel therapeutic alternatives like HyperAcute(R) Pancreas immunotherapy to pancreatic cancer patients, and we are looking forward to updating 2 and 3 year survival data from this study at the upcoming ASCO meeting,” commented Dr. Nick Vahanian, Chief Medical Officer of NewLink Genetics. “We are eagerly focused on the progress of our ongoing Phase 3 study of this product candidate based on the positive Phase 2 data,” he added.

Key data from the 69 patient Phase 2 Algenpantucel-L trial demonstrated:

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% (p=0.02, Fisher’s Exact). Prognostic criteria did not significantly differ between the two groups.

Overall 12-month survival was 86%. The predicted 12 month overall survival in our study was 55-63%. 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% (p=0.053, Fisher’s Exact).

The HyperAcute(R) 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. The predominant adverse events related to the immunotherapy were grade one or two injection site reactions, all treated with conservative local therapies.

Anecdotally, three patients with cancer recurrence after receiving algenpantucel-L obtained complete radiographic responses with the use of subsequent chemotherapy. As of May 16, 2012, all three patients remain in remission with no evidence of disease for periods ranging from six to 36 months.

About the Phase 2 Study

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. Adjuvant therapy was to start within seven weeks after surgery. The first cycle of treatment consisted of vaccination with either 100 million or 300 million cells per dose given intradermally on days one and eight. One week after the second vaccination, gemcitabine was administered at 1000mg/m2/week for three weeks, on days one, eight, and 15, in conjunction with HyperAcute(R) immunotherapy dosed on days one and 15 of cycle two. Chemoradiotherapy was initiated one to two weeks after the completion of cycle two. Continuous infusion 5-FU was administered at 250 mg/m2/day for the entire duration of radiation therapy. HyperAcute(R) immunotherapy was administered on days one, 15, 29, and 43 of the chemoradiotherapy stage. A total of up to 14 vaccinations were dosed for patients who completed the entire study treatment.

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