LUND, Sweden, Oct. 4, 2018 /PRNewswire/ -- 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, 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 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:
Center
|
Location
|
Start date
(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:
Mats Grahn
Chief Executive Officer, CEO, Immunovia
Tel.: +46-70-5320230
Email: mats.grahn@immunovia.com
About 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.
About ClinicalTrials.gov
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%.
This information was brought to you by Cision
http://news.cision.com
http://news.cision.com/immunovia-ab/r/immunovia-panfam-1-clinical-trial-now-available-on-clinicaltrials-gov--the-largest-clinical-trials-d,c2635246
The following files are available for download:
http://mb.cision.com/Main/13121/2635246/921003.pdf
|
Immunovia, PR
PanFAM-1 on ClinicalTrials.gov
|
View original
content:http://www.prnewswire.com/news-releases/immunovia-panfam-1-clinical-trial-now-available-on-clinicaltrialsgov-the-largest-clinical-trials-database-in-the-world-300724472.html
SOURCE Immunovia AB