Quintiles, which has run countless clinical trials for cancer drug candidates, is taking a turn as a financial supporter for a study with a $2.6 million contribution directed toward a breakthrough breast cancer trial.
I-SPY 2, is a clinical trial sponsored by The Biomarkers Consortium, a public-private partnership that includes the U.S. Food and Drug Administration, the National Institutes of Health and several major pharmaceutical companies. The trial is designed for women with newly diagnosed, locally advanced breast cancer to test whether investigational drugs can improve upon standard treatment and increase the odds of survival.
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Development costs for breast cancer therapies can exceed $1 billion and take up to 15 years to bring an approved product to market. I-SPY 2 is designed to be a faster and less expensive clinical trial. I-SPY 2 trials started last year and are projected to cost $26 million over five years. Durham, North Carolina-based Quintiles is making its contribution over the next four years of the trials.
The trial, which involves 800 patients, employs a design that uses outcome information from each patient as she goes through the study to help in the treatment plan for the next patient. Conventional clinical trials don’t reveal the results to investigators until a trial’s conclusion. The trial is also using biomarkers from individual patient’s tumors to screen multiple therapies simultaneously, allowing investigators to quickly measure effectiveness. Testing multiple drugs makes it more likely to produce more than one successful treatment that can advance to late-stage clinical trials.
Funding for I-SPY 2 is coming from a variety of sources and includes contributions from grocery retailer Safeway and Johnson & Johnson (NYSE:JNJ). The Foundation for the National Institutes of Health has been working to secure additional funds from companies working in the pharmaceutical industry. Quintiles’ grant is being made through the QuantumLeap Healthcare Collaborative, a nonprofit foundation and a co-manager of the trial.
This video from the Foundation for the National Institutes of Health explains the I-SPY 2 trial:
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