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Continuing down the right pathway
NEWTON, Mass.—As it continues to validate the application of genetic variants in FCGR (Fc gamma receptor) genes, including FCGR3A for predicting response to monoclonal antibodies (mAbs) in cancer treatment, Clinical Data Inc., though its PGxHealth division, forged two new research collaborations in May—one with academia and the other with a clinical treatment and research organization.
The first deal, struck very early in the month, is a broad research collaboration with the University of Pittsburgh with the aim of conducting a series of clinical programs to evaluate the response to mAb-based therapies, such as Erbitux (cetuximab), Rituxan (rituximab) and Herceptin (trastuzumab)—and possibly other mAbs of the IgG1 subclass—in treating a variety of cancers.
The second collaboration, announced May 18, is with the Dana-Farber Cancer Institute in Boston to validate the use of genetic variants in FCGRs in predicting response to Herceptin specifically in patients with breast cancer. The research, directed by Dr. Karen S. Anderson at Dana-Farber, 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.
Both deals follow on the announcement in December 2008 of a research collaboration with Dr. Antonino Musolino and the University Hospital of Parma in Italy to validate the use of genetic variants in the FCGR pathways in predicting response to Herceptin therapy in patients with breast cancer.
These and other collaborations that PGxHealth will pursue in the future are important as interest in the role of genetic variation in FCGR3A continues to grow among researchers and clinicians, says Theresa McNeely, vice president of corporate communications for Clinical Data. As evidence of this, she points to the fact that 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.
In the work with the University of Pittsburgh, Dr. Robert Ferris, associate professor and chief in the Division of Head and Neck Surgery at the University of Pittsburgh Cancer Institute (UPCI), will lead studies focusing on Erbitux in the treatment of head and neck cancer, a therapy that has been approved by the U.S. Food and Drug Administration (FDA) for this use and reportedly increases survival in this population.
McNeely says that PGxHealth and UPCI plan to expand the scope of their research relatively soon to include other cancers and treatments, and the research may go beyond cancer as well, into other disease areas where mAb therapies are deemed important, such as rheumatoid arthritis.
"UPCI is one of the leading research institutions in the country and this collaboration represents a significant step forward in our goal to expand our Fc gamma program in oncology," said Marcia Lewis, vice president, biomarker development at PGxHealth.
Up in Boston with Dana-Farber, PGxHealth scientists will collaborate with Anderson and her colleagues to analyze certain genetic variants in breast cancer patients enrolled in two independent studies who are receiving Herceptin along with other drugs in the neoadjuvant setting or in the metastatic disease setting. Researchers will evaluate FCGR genotypes and their association with pathological and clinical response to Herceptin therapy, and preliminary data from the studies is expected by the end of this year.
"We are very excited to be working with Dr. Anderson and the Dana-Farber Cancer Institute, a premier institution known for its groundbreaking cancer research, to expand the potential clinical utility of testing for Fc gamma receptor variants in oncology," Lewis says. "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."