Abbott and GSK to Collaborate on Molecular Diagnostic Test to Select Candidate Patients...

Mon Jul 13, 2009 12:45pm EDT
 
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Abbott and GSK to Collaborate on Molecular Diagnostic Test to Select Candidate
Patients for Future Cancer Immunotherapy



DES PLAINES, Ill., July 13 /PRNewswire-FirstCall/ -- Abbott announced today
that it has entered into an agreement with GlaxoSmithKline (GSK) to develop an
automated molecular diagnostic test, based on polymerase chain reaction (PCR)
technology, intended to screen non-small cell lung cancer (NSCLC) tumors for
expression of the MAGE-A3 antigen.  GSK's MAGE-A3 ASCI (Antigen Specific
Cancer Immunotherapy) candidate is currently being evaluated as an adjuvant
treatment in resected NSCLC in the Phase III clinical study MAGRIT, the
largest lung cancer treatment study ever conducted. To be eligible to receive
GSK's MAGE A3 ASCI, patients must have MAGE-A3 expressing NSCLC tumors. 
MAGE-A3 is a tumor-specific antigen that is expressed in non-small cell lung
cancer and a wide variety of other cancers, but not in normal cells.  

Under terms of the agreement, Abbott, in conjunction with GSK, will develop
and commercialize a PCR test designed to detect MAGE A3 for use on the Abbott
m2000((TM)) automated instrument system.  

"This is an exciting collaboration with a leading company in cancer
immunotherapy research," said Stafford O'Kelly, head of Abbott's molecular
diagnostics business. "The agreement is indicative of our focus on
personalized medicine and developing analytical molecular tools to identify
patients most likely to benefit from important pharmacogenomic therapies."

Currently, there are no nucleic acid based tests approved by the U.S. Food and
Drug Administration for use in identifying patients who may derive treatment
benefits from targeted non-small cell lung cancer therapies.  

"Lung cancer is the biggest cancer killer globally," said Vincent Brichard,
M.D., Ph.D., vice president and head of Immunotherapeutics, GSK.  "Through
this partnership we aim to make MAGE-A3 testing of lung tumors available in
standard pathology labs around the world. This means patients globally could
be able to find out if they are eligible and can potentially benefit from
targeted cancer treatment against this antigen, such as GSK's MAGE-A3
candidate ASCI." 

ASCIs and MAGE-A3 ASCI
GSK's ASCIs represent a novel class of medicines designed to train the immune
system to recognize and eliminate cancer cells in a highly specific manner.
These novel cancer immunotherapeutics combine tumor antigens, delivered as
purified recombinant proteins, and GSK's proprietary Adjuvant Systems, which
are specific combinations of immunostimulating compounds selected to increase
the anti-tumor immune response. ASCIs are being investigated in the clinic to
support their use to reduce the risk of tumor recurrence following surgery, or
to impact tumor growth in an early metastatic setting. The highly specific
mode of action of GSK's ASCIs allows development of diagnostic tools to aid in
selecting patients eligible for the treatment, depending on the expression of
the tumor antigens. 

MAGE-A3 is a tumor-specific antigen that is expressed in a large variety of
cancers, including melanoma, non-small cell lung cancer, head and neck cancer,
bladder cancer, with no expression in normal cells.  Expression of the MAGE-A3
gene has been observed in testicular cells but without antigen presentation
capabilities. MAGE-A3 protein has been in-licensed by GSK from the Ludwig
Institute for Cancer Research, the largest international academic institute
dedicated to understanding and controlling cancer.  MAGE-A3 ASCI is an
investigational compound and it is not approved for use in any indication in
any country at this time. 

Websites have been created to provide information on the ASCI approach and the
MAGRIT clinical study. Please visit www.immunotherapyforcancer.com and
www.gsk-asci.com for more information.

Molecular Tests for Oncology  
Abbott's development efforts in areas such as MAGE-A3 will further build its
leadership position in cancer diagnostics and personalized medicine. Abbott is
a pioneer in the use of molecular tests based on PCR and fluorescence in situ
hybridization (FISH) technologies to aid clinicians in the selection of
appropriate pharmacogenomic therapies.  Abbott's FISH products deliver
unsurpassed sensitivity for early diagnosis and monitoring of cancer and the
ability to identify patients who can benefit from appropriate therapies,
improving outcomes and extending patient survival.  

The m2000 System
The Abbott m2000 system is an automated instrument for DNA and RNA testing in
molecular laboratories. The m2000 system is based on real-time PCR technology
and consists of the m2000sp for automated sample preparation and the m2000rt
for PCR detection an analysis, offering an efficient workflow for the lab.  

The Abbott m2000 instrument is marketed in most major markets throughout the
world and offers an extensive menu for infectious disease testing, including
HIV viral load, hepatitis B viral load, chlamydia detection,
chlamydia/gonorrhea (CT/NG) multiplexed assay, hepatitis C (HCV) viral load,
HCV genotyping, cytomegalovirus, Epstein-Barr virus and human papillomavirus. 
With the exception of the CT/NG assay, these tests currently are not available
on the m2000 in the United States.

About Abbott Molecular
Abbott's molecular diagnostics business, headquartered in Des Plaines, Ill.,
provides physicians with critical information based on the early detection of
pathogens and subtle changes in patients' genes and chromosomes, allowing for
earlier diagnosis, selection of appropriate therapies and monitoring of
disease progression. The business includes instruments and reagents used to
conduct sophisticated analysis of patient DNA and RNA. Additional information
is available on Abbott Molecular's Web site at www.abbottmolecular.com.     

About Abbott 
Abbott (NYSE: ABT)  is a global, broad-based health care company devoted to
the discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics.  The
company employs more than 72,000 people and markets its products in more than
130 countries. 

Abbott's news releases and other information are available on the company's
Web site at www.abbott.com.



SOURCE  Abbott

Media, Don Braakman, +1-847-937-0080, or Financial, Tina Ventura,
+1-847-935-9390, both of Abbott

 

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