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PGxHealth embarks on Italian connection
NEWTON, Mass.—PGxHealth, a division of Clinical Data Inc., announced recently a research collaboration with Dr. Antonino Musolino and the University Hospital of Parma, Italy, to validate the use of genetic variants in the FCGR pathways in predicting response to trastuzumab (Herceptin) therapy in patients with breast cancer. The research will include an international prospective trial to evaluate the association of genetic variants, such as the FCGR3A F158V genotype, with response to trastuzumab in breast cancer treatment.
The collaboration will serve to expand PGxHealth's Fc gamma receptor (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.
"We already sell a test that focuses on use of this marker for rituximab, and we saw a greatly expanded utility for this kind of testing, so we wanted to work with Dr. Musolino and help confirm his data and collaborate with him on prospective trials that will show the criticality or predictive value of this genotype," says Marcia Lewis, vice president of biomarker development for PGxHealth.
"In our pilot study, Fc gamma receptor genetic variants were strong predictors of trastuzumab efficacy in HER-2 positive metastatic breast cancer patients," says Musolino. "Combining our efforts with PGxHealth's to confirm this result is an important step forward in optimizing breast cancer treatment and may lead to a fully validated pharmacogenetic test for targeted therapy in solid tumors."
PGxHealth scientists will collaborate with Musolino and his colleagues to analyze certain genetic variants in patients enrolled in an international trial of some 300 breast cancer patients receiving trastuzumab and other drugs in the neoadjuvant setting to determine whether the FCGR3A F158V and other variants are predictive of clinical outcome. This study should be done by the end of 2009.
"This effort is directed at breast cancer right now, but we also understand the applicability of this gene and pathway to other cancers for which monoclonal antibody therapy is being used," Lewis says. "We look at lymphoma ourselves, where our own test is being applied, in addition to the breast cancer applications, but there is also the possibility of colorectal cancer and possibly head and neck cancers down the line."
Because monoclonal antibody therapies are used in a variety of clinical settings, the Parma findings are notable for their applicability not just to the neoadjuvant but also the adjuvant and metastatic settings, Lewis adds.
The work certainly will be valuable for clinical trials, Lewis acknowledges, and drug developers are looking at the same polymorphisms as PGxHealth and Dr. Musolino, but she stresses that her company is focused on the personalized medicine applications, to enable physicians to prescribe the most efficacious drugs they can, providing the right therapy and adjusting it according to genotype.
"Clinical evidence demonstrating the importance of FCGR variants in predicting the efficacy of monoclonal antibody-based cancer therapies continues to grow, and augments our own efforts related to IgG1 antibody response," says Dr. Carol R. Reed, chief medical officer of Clinical Data. "By establishing collaborations with world-renowned oncology researchers...we are aiding the development of genetic tests that can predict drug response and help guide treatment decisions for clinicians and their patients with cancer." DDN