New centers give study near complete coverage of North American FPC sites in drive to validate IMMrayTM PanCan-d, the first blood based test for early detection of pancreatic cancer

Immunovia AB today announced that four additional North American Familial Pancreatic Cancer (FPC) sites are to participate in PanFAM-1, the largest ever prospective study looking at early diagnosis in high-risk individuals with heredity risk of pancreatic cancer. Designed to validate Immunovia ́s innovative blood test, IMMray™ PanCan-d, PanFAM-1 study will analyze more than two thousand individuals over three years across sites in Sweden, the US and Europe already offering FPC screening programs. The aim is to improve the outcome for the cancer patients and to prove the overall healthcare benefits of testing persons with heredity risk of pancreatic cancer in a prospective study needed for FDA clearance and reimbursement. PanFAM-1 is now an observational study that started 2016. Interim analysis is planned to be performed towards the end of 2019, followed by an interventional phase planned to finish in 2021. PanFAM-1 final results are expected 2021. PanFAM-1 prospective study continues Immunovia’s strategy to launch an early detection strategy for pancreatic cancer.

Parallel to this Immunovia is also running a study for another recently identified high risk group, new onset diabetics over 50 years of age.

The newly recruited PanFAM-1 centers and their PI’s are:

• Research Institute of the McGill University Health Centre (RI-MUHC) – PI: Dr. George Zogopoulo
• The Trustees of the University of Pennsylvania – PI: Dr. Bryson Kantona
• University of Massachusetts – PI: Dr. Giles Whalen
• Yale University – PI: Dr. James Farell

According to Rolf Ehrnström, CSO Immunovia, PI for the entire study, the new participants are significant for two reasons: “McGill, Yale, Pennsylvania and Massachusetts, we 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”.

“We are delighted to welcome these new participants to PanFAM-1,” commented Mats Grahn, CEO, Immunovia. “They all repeat the message we have had from other sites running FPC screening programmes around the world and patient groups, that there is a real need for early detection and for a test such as IMMray™ PanCan-d. ”

The other PanFAM-1 partners to date are: Mount Sinai, New York; Knight Cancer Institute at Oregon Health and Sciences University, Portland, OR; The University of Pittsburgh Medical Center Pittsburgh, PA; The Massachusetts General Hospital, Boston, MA; NYU School of Medicine, New York; The University of Liverpool, UK; Ramon y Cajal Institute for Health Research Madrid, Spain; University Hospital of Santiago de Compostela, Spain, Clínica Universidad de Navarra, Spain; and Karolinska Institutet, Stockholm, Linköping University Hospital and Sahlgrenska University Hospital, Gothenburg  in Sweden. Advanced discussions over potential participation continue with several other European and US centers running high risk surveillance programs. The goal is to close the recruitment of new centers by end 2018.  More information about PanFAM-1 trial can be found on: www.clinicaltrials.gov.