McGill, Yale and Universities of Pennsylvania and Massachusetts Join PanFAM-1, the Largest Ever Prospective Multicenter Clinical Study for Early Detection of Pancreatic Cancer
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
LUND, Sweden, Nov. 13, 2018 /PRNewswire/ -- 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.
For more information, please contact:
Chief Executive Officer, CEO, Immunovia
Immunovia AB was founded in 2007 by investigators from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden. Immunovia's strategy is to decipher the wealth of information in blood and translate it into clinically useful tools to diagnose complex diseases such as cancer, earlier and more accurately than previously possible. Immunovia´s core technology platform, IMMray™, is based on antibody biomarker microarray analysis. The company is now performing clinical validation studies for the commercialization of IMMray™ PanCan-d that could be the first blood based test for early diagnosis of pancreatic cancer. In the beginning of 2016, the company started a program focused on autoimmune diseases diagnosis, prognosis and therapy monitoring. The first test from this program, IMMray™ SLE-d, is a biomarker signature derived for differential diagnosis of lupus, now undergoing evaluation and validation. (Source: www.immunovia.com)
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.
About Pancreatic Cancer
Pancreatic Cancer is one of the most deadly and difficult to detect cancers, as the signs and symptoms are diffuse and similar to other diseases. There are more than 40,000 deaths and over 50,000 new cases diagnosed each year in the U.S. alone, and the five-year survival rate for pancreatic cancer is currently 5-8 %. It is predicted to become the second leading cause of cancer death by 2020. However, because resection is more successful in stage I/II, early diagnosis can significantly improve pancreatic cancer patients' 5-year survival rates from 5-8 % to up to 49%.
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