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August 29, 2007Faster, please.The National Cancer Institute recently released a new study showing that it is possible to cut development times for cancer drugs by using so called "Phase 0" testing, where a drug's mechanism of action is tested in patients using a biomarker to evaluate efficacy. Translation: this new type of testing can cut 6-12 months from the time needed to move a drug from the lab bench to a patients bedside. And, when it comes to cancer, every month counts. Instead of being tested in the traditional phase I clinical trial, which explores drug safety and tolerance, ABT-888 was tested in a new type of study called an early Phase I trial (also sometimes called a Phase 0 trial). Conducted as part of the pioneering NCI Experimental Therapeutics (NExT) program, this early phase I trial shows that using an approach that adds a focus on the mechanism of action (the specific target in a cell that the drug attacks) can reduce the number of patients required for an early clinical study, and the time necessary to gather critical information for development of the drug. "With this trial, NCI is doing much more than studying a new intervention; it is blazing a trail for early phase trials, which will hasten our progress across cancer research and drug discovery," said NCI Director John E. Niederhuber, M.D. "Conducting the ABT-888 trial also required close collaboration and consultation with the FDA, in order to negotiate the prototype for a new regulatory process." "The time from initiation of the trial to the analyses of the data that provided proof-of-concept was less than six months," said Shivaani Kummar, M.D., NCI Center for Cancer Research (CCR), who led the trial. More, and better, drugs to cancer patients, faster. That's a recipe for success. Posted by Paul Howard at August 29, 2007 10:40 AM CommentsPost a comment |
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