– Program to Validate Genetic Variants and Discover New Genetic
Associations Impacting Trastuzumab Response –
PGxHealth, a division of Clinical Data, Inc. (NASDAQ: CLDA), today
announced that it has established a research collaboration with the
Dana-Farber Cancer Institute (DCFI) to validate the use of genetic variants
in Fc gamma receptors (FCGRs), including FCGR3A, in predicting response
to trastuzumab (Herceptin) therapy in patients with breast cancer. The
research, directed by Karen S. Anderson, M.D., Ph.D. at Dana-Farber,
complements other studies underway to further demonstrate the
contribution of genetic variants in the FCGR family to monoclonal
antibody (mAb) response in cancer treatment. Importantly, the
collaboration includes a large-scale effort to discover new genetic
variants influencing response to Herceptin that may also predict
response to other mAbs of the IgG1 class. The collaboration expands
PGxHealth’s FCGR program, which includes its PGxPredict®:RITUXIMAB
test for a gene variant used to determine response to rituximab
monotherapy in follicular non-Hodgkin’s lymphoma. Fc gamma receptors are
antibody receptors found on immune-regulatory white blood cells, such as
T-cells.
PGxHealth scientists will collaborate with Dr. Anderson and her
colleagues to analyze certain genetic variants in breast cancer patients
enrolled in two independent studies and receiving Herceptin along with
other drugs in the neoadjuvant setting (before primary treatment), or in
the setting of metastatic disease. Researchers will evaluate FCGR
genotypes and their association with pathological and clinical response
to Herceptin therapy. Preliminary data from the studies is anticipated
by the end of 2009.
“We are very excited to be working with Dr. Anderson and the Dana-Farber
Cancer Institute, a premier institution known for its ground-breaking
cancer research, to expand the potential clinical utility of testing for
Fc gamma receptor variants in oncology,” said Marcia Lewis, Vice
President, Biomarker Development at PGxHealth. “This collaboration will
enable us to expand our knowledge of the role of FCGR and other
inherited genetic variants of immune response as they impact the use of
monoclonal antibody therapies in cancer. In the future, it may be
possible to combine testing for inherited genetic factors with tumor
markers, such as HER-2/neu, KRAS and others, to develop diagnostic tests
that will be highly predictive of individual response to cancer
therapies.”
The role of genetic variation in FCGR3A continues to gain attention
among researchers and clinicians. The impact of FCGR3A and other genes
in the FCGR gene family for optimizing treatment of lymphomas, breast,
and colorectal cancers with rituximab, trastuzumab, cetuximab and other
recombinant mAbs was the focus of the MAb IMPACT meeting of oncology
experts, held in November 2008 in Tours, France.
FCGR3A, a gene that encodes an Fc gamma receptor, binds both
natural and therapeutic IgG1 antibodies.
