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Thomas Dworetzky, Contributing Reporter | June 19, 2017
Cerveau Technologies investigational imaging agent [F-18] MK-6240 has received clearance for its Investigational New Drug application (IND).
“We are pleased to reach this important milestone in the development of our novel, next-generation agent for the detection and quantitation of [neurofibrillary tangle] NFT in patients,” said Rick Hiatt, President of Cerveau Technologies in a statement.
Cerveau Technologies is a partnership between Enigma Biomedical Group and Sinotau Pharmaceutical Group. It licensed [F-18] MK-6240 on a worldwide basis from Merck.
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As a result of the approval, Cerveau now intends to study the use of the agent in PET scans to assess “the status and progression of NFTs in the brain,” according to a company statement.
Such NFTs, made from tau protein, are “a hallmark of several neurodegenerative diseases, including Alzheimer’s disease,” it noted.
“Clinical studies will proceed to determine the ability of MK-6240 to stage disease and quantify the potential effects of therapeutic treatments for neurodegenerative disease, including Alzheimer’s Disease,” said Hiatt, adding that as well as working with present collaborators, the company is also seeking other partners “to develop this agent as a potential biomarker for staging patients, and monitoring their therapy throughout treatment.”
In February, Cerveau Technologies
signed an agreement with Siemens’ PETNET Solutions that gave it the right to manufacture the agent, according to a report at the time.
Cerveau has announced plans to begin a Phase III clinical trial in 2018.
PETNET is set to manufacture [F-18] MK-6240 clinical trial material at select radiopharmacies in the U.S. with the possibility of expanding into additional locations. Its CEO, Barry Scott, stated at that time that its large network of radiopharmacies will be needed to support the availability of [F-18] MK-6240.
“There is a critical need for sensitive biomarkers for diagnosis and monitoring of tau pathology in neurodegenerative diseases, to allow for more appropriate staging of disease states, and measuring the effect of candidate disease-modifying therapeutics,” Darryle Schoepp, vice president, discovery at Merck Research Laboratories, noted in January.
Late in 2016, the potential of tau PET imaging for investigating diseases like Alzheimer's was highlighted by a Swedish study in which researchers compared tau PET images and brain tissue from the same individual for the first time.
