The European Medicines Agency (EMA) has issued a positive qualification opinion on an imaging test, or biomarker, for use as a tool to improve Parkinson’s clinical trials, according to the Tucson, AZ-based Critical Path Institute and its Critical Path for Parkinson’s (CPP) consortium, which hailed the EMA qualification as the first such regulatory designation for a Parkinson’s biomarker.
The EMA move follows a 2015 letter by the U.S. Food and Drug Administration supporting use of the imaging test in clinical trials to determine the presence of a dopamine transport deficiency in the brain to help target early stages of Parkinson’s. The biomarker involves the intravenous injection of a small amount of a radioactive tracer before the brain images are acquired. The brain scans already are being included in new clinical trials by Cambridge, MA-based Biogen.
Because the disease is a progressive condition caused by the gradual loss of cells in the brain, researchers say the best chance to intervene with treatments that can slow, stop, or reverse damage is during the earliest stages of the condition, making it more difficult to predict disease progression during the course of trials.
“This endorsement from the European Medicines Agency represents many years of hard work and incredible collaboration among companies, universities, and charities facilitated by the Critical Path Institute,” says Dr. Diane Stephenson, executive director of CPP, who led the work. “These brain scans in themselves are not new, but until now there has not been a clear consensus that they can and should be used to select participants for clinical trials.”
The CPP consortium, in partnership with charity-supported Parkinson’s UK, collaborates with industry, academics, advocacy organizations, and government agencies to develop solutions to optimize drug development for Parkinson’s.
Traditionally, Parkinson’s has been viewed as a disorder in which individuals don’t have enough of a chemical called dopamine because specific nerve cells inside their brain have died. Current research indicates that the processes that lead to dopamine deficit start decades earlier making it a pressing need to increase the understanding of Parkinson’s progression, according to CPP.
Filed Under: Drug Discovery