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Clinical Data and University of Pittsburgh form research alliance

PGxHealth, a division of Clinical Data, has started a broad research collaboration with the University of Pittsburgh to discover and further validate the application of genetic variants in Fc gamma receptor genes, including FCGR3A, for predicting response to monoclonal antibodies in cancer treatment.

The strategic collaboration aims to conduct a series of clinical programs to evaluate the response to mAb-based therapies, such as Erbitux (cetuximab), Rituxan (rituximab) and Herceptin (trastuzumab) and potentially other monoclonal antibodies (mAbs) of the IgG1 subclass in treating a variety of cancers.

The collaboration builds upon the large and growing body of evidence demonstrating the contribution of genetic variants in the Fc gamma receptor (FCGR) family to mAb response in cancer treatment. It also expands PGxHealth’s own FCGR program, which includes collaborations with other prominent researchers at leading institutions, and its own PGxPredict:Rituximab test for a gene variant used to determine response to rituximab monotherapy in follicular non-Hodgkin’s lymphoma.

The initial research program is between PGxHealth and the University of Pittsburgh. Robert Ferris, Chief of head and neck surgery division at the University of Pittsburgh Cancer Institute (UPCI), will lead studies focusing on Erbitux in the treatment of head and neck cancer.

Erbitux has been approved by the FDA for use in the treatment of patients with head and neck cancer and has been shown to increase survival in this population. PGxHealth and UPCI plan to expand the scope of their research in the near term to include other cancers and treatments. The research may also extend to other disease areas where mAb therapies are important, such as rheumatoid arthritis.

Marcia Lewis, vice president of biomarker development at PGxHealth, said: “We intend to expand the scope of our research with UPCI to include response to other mAb-based therapies, such as Rituxan (rituximab) and Herceptin (trastuzumab) and mAbs of the IgG1 subclass, in treating a variety of cancers and other diseases where mAb therapies are used, such as rheumatoid arthritis.”