AMES, Iowa, June 19, 2012 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NLNK) today announced that in the second quarter of 2012 it passed the midpoint in enrollment in its Phase 3 HyperAcute Pancreas immunotherapy product candidate (algenpantucel-L) trial as number of participating institutions reached to 74 sites around the US.

"Now that we have passed the midway point of trial enrollment, we are confident that the trial will be fully enrolled before the end of 2013," said Dr. Nick Vahanian, President and Chief Medical Officer of NewLink Genetics. He added, "We are very thankful for the support we have received from our patients and investigators and based on currently available data we anticipate reaching the trigger event for the first interim analysis in early 2013."

The current Phase 3 study is designed to evaluate the benefit of HyperAcute Pancreas in up to 722 patients who have undergone resection of pancreatic cancer. The clinical trial design was approved by the FDA under Special Protocol Assessment prior to opening in May 2010 and the HyperAcute Pancreas was granted Fast Track and Orphan Drug designation in the fourth quarter of 2010.

This Phase 3 trial was initiated based on encouraging results from the Company's Phase 2 study of HyperAcute Pancreas in patients who had undergone resection of pancreatic cancer. The Phase 2 results were recently updated and showed one, two and three year survival of 86% , 51% and 42% respectively, based on Kaplan-Meier analysis with a 33 months of median follow up. Demonstrating improvements of 37%, 59% and 121% over predicted one, two and three outcomes respectively based upon nomogram analysis of these same patients.

About algenpantucel-L

NewLink's algenpantucel-L immunotherapy product candidate consists of a group of two allogeneic pancreatic cancer tumor cell lines that were modified to express Alpha-Gal. These cell lines were chosen to provide a broad coverage of pancreatic cancer antigens. Each of the modified cell lines is grown in large cultures, harvested, irradiated and packaged. Approximately 150 million cells of each HyperAcute Pancreas cell line are given by intradermal injection with each treatment. A series of up to 14 treatments using both cell lines over a period of six months was used in NewLink's Phase 2 clinical trial. In NewLink's Phase 3 trial protocol, NewLink is adding an additional series of monthly, maintenance treatments, to be given during the next six months.

About algenpantucel-L clinical trials

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 1 and 8. 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 Pancreas immunotherapy dosed on days 1 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 Pancreas immunotherapy was administered on days 1, 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.

About the Phase 3 Study

See more here:
NewLink Updates Enrollment Information for Its Pivotal Phase 3 HyperAcute(R) Pancreas Immunotherapy (algenpantucel-L ...

Comments are closed.