Agendia to Play Pivotal Role in ISPY-2 Trial for Breast Cancer

I-SPY 2 is an exciting and groundbreaking new clinical trial model that will help scientists quickly and efficiently test the most promising drugs in development for women with higher risk, rapidly growing breast cancers-women for whom an improvement over standard treatment could dramatically change the odds of survival. I-SPY is an initiative of the Biomarkers Consortium, a unique public-private partnership that includes the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and major pharmaceutical companies, led by the Foundation for the National Institutes of Health (FNIH).

"Cancer tumor profiling in the neoadjuvant setting is critical to the success of the I-SPY 2 trial. Agendia is uniquely positioned to be a part of the Biomarker Consortium in this landmark study, and proud to be working side by side with a large number of visionary therapeutic companies and research centers," said Bernhard Sixt, Chief Executive Officer of Agendia. "Agendia's MammaPrint test has proven value for breast cancer recurrence in the neoadjuvant and adjuvant settings, Agendia's TargetPrint provides objective, quantitative information about the expression of ER, PR and Her-2neu, while our DiscoverPrint measures the expression of the whole genome. In concert they will form an integral part of the clinically relevant discoveries the Consortium aims to make."

Scientists from the National Cancer Institute (NCI), FDA, and nearly 20 major cancer research centers across the United States have united to develop and conduct this unprecedented large-scale scientific collaboration to test novel breast cancer drugs in the neoadjuvant clinical trial setting. Results will be made broadly available to the cancer research and development community in order to foster this integrated approach to improve clinical trial success and the efficacy of cancer therapeutics.

The adaptive design of the I-SPY 2 trial promises to integrate and advance multiple biomarker types into a new generation of predictive signatures. This approach has the potential to both streamline Phase III trial designs and yield a new generation of personalized diagnostic tools with regulatory acceptance and approval. Information from Agendia's whole genome expression profiling, essentially "snapshots" of tumor biopsies before and after administration of the neoadjuvant therapies under investigation, combined with data from the other trial participants, promises to accelerate trials, reduce patient enrollment numbers, and generate huge savings for commercial, research and governmental institutions.

For background information on the I-SPY 2 trial, please go to http://ispy2.org

Source: LSH