NewLink Updates Enrollment Information for Its Pivotal Phase 3 HyperAcute(R) Pancreas Immunotherapy (algenpantucel-L) Trial
"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.
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
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
In
About Pancreatic Cancer
The
Pancreatic cancer can generally be divided into three broad categories: (1) local disease, in which the cancer is confined to the pancreas and can be removed surgically, which is called resection; (2) locally advanced disease, in which the cancer has spread locally and may or may not be eligible for resection because it has invaded tissues that should not be removed, such as key nerves and arteries; and (3) metastatic disease, in which the tumor has spread beyond the region of the pancreas.
About
Safe Harbor Statement
This press release contains "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the prospects of algenpantucel-L including the expected requirements and timing for completion of enrollment for NewLink's Phase 3 clinical trial and the timing of a future interim analysis of the data from the trail as well as potential implications of the previously reported data generated in NewLink clinical trials. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with clinical trials and the regulatory
approval process. These and other factors are identified and described in more detail in the Company's filings with the
CONTACT:Source:Gordon Link Chief Financial OfficerNewLink Genetics 515.598.2925 glink@linkp.com
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