Press releasesOctober 4th, 2018 13:52
Immunovia PanFAM-1 clinical trial now available on ClinicalTrials.gov, the largest clinical trials database in the world
LUND, SWEDEN ― Immunovia has developed a blood based biomarker signature for early detection of pancreatic cancer called IMMray™ PanCan-d. To validate IMMray™ PanCan-d, Immunovia started PanFAM-1 (https://immunovia.com/immray-pancan-d/prospective-studies-and-next-step/panfam-1/), the largest ever multicenter clinical trial for early detection of pancreatic cancer in familial/hereditary high risk group, in collaboration with major pancreatic cancer centers from Europe and US. To provide patients, their families, health care professionals and the public with the information about this clinical trial, Immunovia registered PanFAM-1 study to ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03693378?term=PANFAM&rank=1) which is a web-based registry of clinical trials. It is run by the United States National Library of Medicine at the National Institutes of Health, and is the largest clinical trials database, currently holding registrations from over 230,000 trials from 204 countries in the world.
PanFAM-1 is an observational study that started 2016 and will be used to collect and analyze more than two thousand high risk individuals over a three-year period, across multiple sites in the US and Europe that are already offering familial pancreatic cancer screening programs. The goal of the study is to assess the diagnostic accuracy of the IMMray™ PanCan-d test in a prospective study needed for FDA clearance and reimbursement.
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.
“What differentiates this effort from previous blood test-based early detection studies is its international scope and the encouraging results in patients with early stages of pancreatic cancer” says Lynn Matrisian, PhD, MBA and chief science officer at PanCAN1, summarizing in their blog the recent Immunovia publication in the Journal of Clinical Oncology.
The PanFAM-1 partners to date are:
(press release link)
|PanFAM-1 Start announced||2016-12-20|
|The University of Liverpool||United Kingdom||2016-01-19|
|The Mount Sinai Hosiptal, New York||NY, USA||2016-02-09|
|Ramon y Cajal Institute for Health Research, Madrid||Spain||2016-12-09|
|Sahlgrenska University Hospital, Gothenburg||Sweden||2017-12-20|
|The University of Pittsburgh Medical Center||PA, USA||2017-12-22|
|The Massachusetts General Hospital, Boston||MA, USA||2018-02-08|
|University Hospital of Santiago de Compostela||Spain||2018-02-16|
|NYU School of Medicine, New York||NY, USA||2018-04-12|
|Clínica Universidad de Navarra (IRYCIS)||Spain||2018-05-04|
|Linköping University Hospital||Sweden||2018-05-22|
|Karolinska Institute, Stockholm||Sweden||2018-08-03|
Enrolment discussions continue with several other European and US centers running high-risk surveillance programs.
1PanCAN (Pancreatic Cancer Action Network) is the world´s largest patient advocacy group dedicated to improving pancreatic cancer patient outcomes through driving awareness, research, clinical initiatives, supporting patient services and advocacy. PanCAN was founded in 1999 in the USA.
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. (Source: www.immunovia.com)
Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the Web site (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a "registry and results database."
ClinicalTrials.gov contains information about medical studies in human volunteers. Most of the records on ClinicalTrials.gov describe clinical trials (also called interventional studies). A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes. ClinicalTrials.gov also contains records describing observational studies and programs providing access to investigational drugs outside of clinical trials (expanded access). Studies listed in the database are conducted in all 50 States and in 204 countries.
ClinicalTrials.gov does not contain information about all the clinical studies conducted in the United States because not all studies are required by law to be registered (for example, observational studies and trials that do not study a drug, biologic, or device). (Source: www.ClinicalTrials.gov)
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 5-7 %. 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 5-7 % to potentially 50-60%.