LUND, Sweden—A prospective study exploring early diagnosis in people with hereditary risk of pancreatic cancer—the largest ever, according to Immunovia AB—is getting a little larger with the addition of four more participant sites. The four new North American Familial Pancreatic Cancer (FPC) sites that are joining the PanFAM-1 study consist of the Research Institute of the McGill University Health Centre, the Trustees of the University of Pennsylvania, the University of Massachusetts and Yale University. PanFAM-1 is aiming to validate IMMray PanCan-d, Immunovia's blood test for the early detection of pancreatic cancer.
“We are delighted to welcome these new participants to PanFAM-1,” Mats Grahn, CEO of Immunovia, said in a press release. “They all repeat the message we have had from other sites running FPC screening programs around the world and patient groups, that there is a real need for early detection and for a test such as IMMray PanCan-d.”
Rolf Ehrnström, CSO for Immunovia and principal investigator for the study, said that with the new additions, “[W]e now cover a large proportion of the reference centers for pancreatic cancer in North America and further strengthen the position of PanFAM-1 as the largest multicenter study currently in the world for the hereditary risk group. Members of families with heredity for pancreatic cancer have an increased risk of developing pancreatic cancer, but so far we lack accurate, non-invasive early diagnostic tools.”
PanFAM-1 began in 2016, and the observational study is seeking to analyze “more than 1,000 high-risk individuals over a three-year period, across multiple sites in the U.S. and Europe that are already offering FPC screening programs,” according to Immunovia's website. The expected date for performing interim analysis for the study is the end of 2019, with an interventional phase to follow that is expected to conclude in 2021. Final results are also forecast for 2021.
Additional study partners include: Mount Sinai; Knight Cancer Institute at Oregon Health and Sciences University; The University of Pittsburgh Medical Center Pittsburgh; The Massachusetts General Hospital; NYU School of Medicine; The University of Liverpool; Ramon y Cajal Institute for Health Research Madrid; University Hospital of Santiago de Compostela,; Clínica Universidad de Navarra; Karolinska Institutet; Linköping University Hospital; and Sahlgrenska University Hospital.
According to Immunovia, its IMMray PanCan-d has proven capable of detecting stage I and II pancreatic cancer with an accuracy of 96 percent, and the test could “dramatically increase patient survival rates: from 5 to 8 percent to up to 49 percent.” The company adds that its test could fill a number of market needs, including screening for high-risk patients, such as those with a familial history of pancreatic cancer; patients over the age of 50 years who have been newly diagnosed with type 2 diabetes, a subgroup that is six to eight times more likely to develop pancreatic cancer within one to three years; and patients with vague symptom profiles, for whom clinicians suspect or wish to rule out pancreatic cancer.
In addition to PanFAM-1, IMMrat PanCan-d is also being tested in two other prospective studies: PanDIA-1, in new onset diabetics who are 50 or older; and PanSYM-1, in patients with vague symptoms and other risk factors.