Duke University in line for $19M to run neurological PhI trials

Duke University could be handed as much as $19 million from the National Institutes of Health (NIH) to manage first-in-human studies for conditions such as Alzheimer’s.

The decade-long deal, awarded by the NIH’s National Institute of Neurological Disorders and Stroke, will see Duke design, manage and conduct Phase I trials at the Duke Clinical Research Unit (DCRU).

The DCRU has 40 beds as well as an observation facility.

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The NIH Blueprint for Neuroscience Research Neurotherapeutics Network will help support the University over the coming years. Its stated aim is to speed up development of promising new therapies from the lab to the clinic.

Duke will under the terms of the contract assess new compounds or therapies, including small molecules, peptides, proteins and oligonucleotides. Being Phase I-orientated, the majority of these studies will look at safety in healthy volunteers--with a particular focus on assessing the rate of drug absorption into the body, as well as the time it takes for a drug to be removed from the body.

“This award reinforces Duke’s position as a leader in early-phase trials,” said Andrew Krystal, director of the Neurosciences Medicine Research Program at the Duke Clinical Research Institute, who will serve as the principal investigator for the trials.

“It’s an opportunity for faculty across multiple disciplines to contribute, and for Duke to be engaged at the ground level in the development of new treatments for neurological disorders.”

There are only a handful of purpose-built, early-stage academic trial centers in the U.S. This also includes the University of Arizona’s Cancer Center, which since 2007 says its aim has been to “provide compassionate cancer care to patients with novel biologically relevant therapies” in Phase I trials.

Duke’s medical research has in fact for the past year been the focus of a long-running 60 Minutes series, specifically surrounding its treatment from a small trial of an aggressive form of brain cancer using an oncolytic virus.

In May, CBS’s topical news program reported that the study had received a breakthrough designation from the FDA.

- check out the release

Related Articles:
Duke’s oncolytic virus study gains FDA Breakthrough: CBS
Duke University sends recs to FDA for new medical device safety evaluation system

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