Researchers at the University of California San Francisco are about to begin a groundbreaking new breast cancer trial designed to speed up the drug discovery process and cut the delivery time of new personalised cancer therapies. The 'Investigation of Serial studies to Predict Your therapeutic response with imaging and molecular analysis 2' trial, dubbed I-SPY-2, will use individual genetic biomarkers to gauge how effective treatments are in specific types of patients, thus enabling more therapies to be tested simultaneously, and eliminated from the trial if they are ineffective.
'We have set up a system where everyone can learn faster and, together, we can dramatically reduce the amount of time and the cost to bring those drugs to market that can make a difference in whether women live or die,' said Dr Laura Esserman, a breast cancer surgeon and researcher at the University of California, San Francisco.
The trial is supported by a number of pharmaceutical companies, and organisations including the US Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
The method is also being hailed for its promise to create 'a coherent body of knowledge' as Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA remarked. As drugs are validated during the trial, which could carry on for many years, they will be added to a master list of 'investigational new drugs', to be held by the Foundation for the National Institutes of Health and shared publicly.
The five drugs to be tested initially are all aimed at shrinking breast tumours before surgery; patients will be given the standard course of therapy plus one trial drug to see which best reduces tumour size.
The researchers will then use early data to identify genetic biomarkers including patterns of gene activity and protein production from one set of patients, to help decide which treatments will suit which patients later in the trial.
'I-SPY 2 will provide a path to personalized medicine,' said Dr. Esserman.
It is currently estimated to take between 12 and 15 years to get one drug into the US market, at a cost of more than one billion dollars.
'The classical clinical trial process has let us down,' Anna Barker, deputy director of the National Cancer Institute.
Senator Arlen Specter of Pennsylvania has spoken of his intention to support an increase in the NIH budget from $30 to $40 billion.
