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NIH Foundation, Biomarkers Consortium Team on Cancer Trials

This article has been updated with comments from a press conference.

By Matt Jones

NEW YORK (GenomeWeb News) – Government and university scientists in the US and drug development companies will undertake a new personalized clinical trial model that will use genetic biomarkers from individual tumors to screen several new drugs for breast cancer.

Led by the Foundation for the National Institutes of Health, the Food and Drug Administration, and the Biomarkers Consortium, the I-SPY2 trial program also will use MRI bioimaging as part of the studies, representatives from the FNIH and the Biomarkers Consortium said today at a press conference at the National Press Club in Washington, DC.

Pharmaceutical companies will donate as many as twelve "promising" drug candidates over the next five years to the program, said Charlie Sanders, who is chairman of the Consortium’s executive committee.

Sanders, who estimated that the trial will cost a total of $26 million over five years, said that the funders and those submitting drugs will not have any say in the design, conduct, or interpretation of the trials. Sanders also said that the program is roughly 60 percent funded now, and is seeking more funding from corporate partners.

The trial will help researchers to "quickly and efficiently test the most promising drugs in development for women with higher risk, rapidly growing breast cancer — women for whom an improvement over standard treatment could dramatically change the odds of survival," according to FNIH.

"We believe that if we can establish the biomarkers that indicate what is really going on in terms of the disease, and we can actually signal back to our drug developers what the biology is, then we can take years off this process and reduce the cost of developing new drugs for breast cancer," added Anna Barker, who is deputy director at the National Cancer Institute and is on the steering committee for cancer for the Biomarkers Consortium.

"[The trials] will change the world of drug development for breast cancer, and in doing that it will change the world of drug development for other cancers … and other diseases," said Barker.

The clinical trials will use Agendia's MammaPrint test and TargetPrint Her2 risk scores, as well as estrogen receptor and progesterone receptor status information and MRI to help determine eligibility for the trial.

The large-scale trial will involve more than twenty university hospitals and medical centers spread around the country, including The University of Texas MD Anderson Cancer Center, the Mayo Clinic in Arizona and Minnesota, the Fred Hutchinson Cancer Research Center, and a number of others.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said that the I-SPY program is "something that has been seriously needed."

"FDA has been very concerned that the current drug development pathway is a serious bottleneck in bringing new innovations to patients," she said.

"Thousands of discoveries arise in the laboratories, only to languish … because of the risk, cost, time and effort that's needed right now to evaluate the performance of even a single candidate in the clinic — hundreds and hundreds of millions of dollars," Woodcock said.

"By using an adaptive clinical trial design, I-SPY will enable rapid adjustments in the strategy of a trial based on real-time information, so that it can be nimble and go toward the winner, so to speak, and move away from strategies that are not succeeding," she explained.

The I-SPY 2 trial follows the I-SPY 1 trial, which began in 2003 and was aimed at predicting how women would respond to standard chemotherapy using multiple MRI scans and biomarkers, but no investigational drugs were tested in that program. I-SPY2 stands for Investigation of Serial Studies to Predict Your Therapeutics Response with Imaging and Molecular Analysis 2.

This incarnation of the I-SPY effort will take the lessons from the first trial and aims to swiftly test which investigational drugs may benefit patients and what tumor characteristics can be used to identify which patients should receive those investigational drugs.

Results from the study, which will initially screen five new drugs and with more added later, will be made available to the public as well as the private research and drug development communities.

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