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Clinical Data Inks PGx Partnership with Dana Farber; Continues to Expand FCGR Portfolio

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Clinical Data announced a partnership with the Dana-Farber Cancer Institute to validate genetic variants in the Fc gamma receptor that predict response of the breast cancer drug Herceptin — the second pharmacogenomics partnership Clinical Data has disclosed in the last two weeks.

Earlier this month, Clinical Data announced a similar research collaboration with the University of Pittsburgh. Under that project, the partners are planning to conduct a series of clinical trials to gauge the link between FCGR gene variants and response to mAb-based therapies, such as Erbitux (cetuximab), Rituxan (rituximab), Herceptin (trastuzumab), and potentially other mAb cancer drugs in the IgG1 subclass [see PGx Reporter 05-06-2009].

In its effort with Dana-Farber Cancer Institute, Clinical Data this week said its PGxHealth division will work with researchers at the institute to analyze genetic variants in breast cancer patients enrolled in two independent studies receiving Herceptin along with other drugs in the neoadjuvant setting, or in the setting of metastatic disease.

The researchers will evaluate FCGR genotypes and their association with pathological and clinical response to Herceptin. The collaboration could also lead to the discovery of new gene variants in FCGR that are predictive of response. The partners expect to have preliminary data from those studies by the end of this year.

"We’ve said for some time now that we’re looking to partner with thought leaders and top research institutions worldwide to continue to build the body of evidence … [that shows] that genetic variants in FCGR, … including FCGR3A, are predictive of response to mAbs in cancer treatment," a Clinical Data spokesperson told Pharmacogenomics Reporter this week. "It is possible that this maybe a class effect relating to response to IgG1 mAbs in the treatment of cancer."

These research partnerships expand Clinical Data's existing FCGR program under its PGx Health division, which includes the PGxPredict: Rituximab test for determining response to rituximab monotherapy in patients with follicular non-Hodgkin's lymphoma.

"Our goal is to validate the biomarkers or genetic variants associated with response and potentially discover other genetic variants in this gene and their impact on response to IgG1 mAb-based therapies," the Clinical Data spokesperson said. The company aims "to utilize this information in developing tests to predict drug response, as we have done with our PGxPredict: Rituximab test."

The announcement is in line with the company's previously outlined 2009 strategic goals, which include driving adoption of its Familion and PGxPredict brand of assays in the cardiovascular disease market, and establishing research collaborations to discover and validate genetic variants in the FCGR pathway that predict response for monoclonal antibodies [see PGx Reporter 12-31-2008].

"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," Marcia Lewis, VP of biomarker development for PGxHealth, said in a statement.

In addition to its agreements with the University of Pittsburgh and Dana-Farber, Clinical Data also has a collaboration deal with Antonino Musolino at University Hospital of Parma, Italy. Musolino conducted some of the initial studies linking genetic variants in the FCGR pathways to Herceptin therapy response in patients with breast cancer.

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