Alliance to Validate Breast Cancer Biomarkers

The information from these biomarkers may aid the development of personalized medicine.

The study follows previous feasibility experiments on a small set of tissue samples from 13 patients treated with Herceptin and chemotherapy. All patients were positive for the Her2 receptor, the molecular target of Herceptin, but not all responded to therapy. However, the study showed that Aclara's eTag System was better able to differentiate between those patients whose disease had not progressed from those whose disease had progressed. These encouraging findings led to this new, larger study.

Aclara will provide research funding to Rinshoken and will have the ability to develop the biomarkers as clinical diagnostics. Rinshoken's new Translational Research Center will coordinate the project. Rinshoken will collect tumor samples and blinded patient data, including treatment histories and outcomes, and Aclara will test the samples for a variety of parameters that it believes could serve as biomarkers of responsiveness to certain targeted therapies, including Herceptin.

The biomarkers under evaluation are proteins and protein complexes and their different functional or activation states that comprise signaling pathways in cells. These pathways enable information transfer within and between cells and control such processes as cell growth, division, and death. When these pathways malfuntion, the affected cells can become cancerous, dividing uncontrollably. Approved targeted therapies such as Herceptin, and many more in development, act on the proteins within these pathways. By measuring the targeted proteins and pathways directly, Aclara believes it can help doctors better determine whether Herceptin or other therapies are most appropriate for treating an individual cancer patient.

"We are very excited about the potential of these candidate biomarkers to help physicians provide better care for patients,” said Thomas Klopack, CEO of Aclara. "The critical information these biomarkers can offer will permit the development of truly personalized medicine.”

Aclara's eTag Systm is able to identify difficult-to-detect protein complexes that can provide unique insights into the likelihood of particular patients to respond to specific therapies.




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