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Clinical Data Teams with Italian Researchers on Cancer Drug PGx

NEW YORK (GenomeWeb News) – Clinical Data today said that it will collaborate with researchers at the University Hospital of Parma in Italy on validating genetic variants in the FCGR pathways that may predict response to a cancer drug.
 
The firm will work with Antonino Musolino on an international prospective trial to evaluate the association of genetic variants, such as the FCGR3A F185V genotype, with patients’ response to trastuzumab (Herceptin) in breast cancer treatment. Clinical Data anticipates the study will include around 300 breast cancer patients receiving the drug along with other drugs in the neoadjuvant setting to determine if FCGR3A F158V and other variants are predictive of clinical outcome.
 
It expects to complete the study by the end of 2009.
 
“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,” Carol Reed, Clinical Data’s chief medical officer, said in a statement.
 
Clinical Data said that the collaboration expands its PGxHealth FCGR program, which includes the PGxPredict:Rituximab test for a gene variant used to determine response to rituximab monotherapy in follicular non-Hodgkin’s lymphoma.
 
The firm’s PGxHealth division is developing genomic-based tests under the PGxPredict and Familion brand names.