KNOXVILLE, Tennessee--(BUSINESS WIRE)--Cerveau Technologies, Inc. today announced that the first healthy volunteer was injected and scanned in the Japan Phase I study of [F18]MK-6240, an investigational imaging agent.
The study received clearance from the Japanese regulatory agency, the Pharmaceutical and Medical Devices Agency (PMDA) and is being conducted at Kobe City Medical Center General Hospital. The study will include healthy volunteers and patients with Mild Cognitive Impairment (MCI) and with Alzheimer’s Disease (AD), and is designed to confirm the safety and pharmacokinetics profile of [F-18]MK-6240 in Japanese.
“The goal of this study is to support in Japan the development programs of the pharmaceutical companies which have licensed the use of [F-18]MK-6240 in connection with their therapeutics candidates,” said Rick Hiatt, Chief Executive Officer, Cerveau Technologies, Inc.
“This is a significant milestone for the development of Tau PET and will facilitate the use of MK-6240 in Japan as an imaging biomarker, as a marker of disease progression, or as a surrogate marker for clinical studies of disease-modifying therapies to treat Alzheimer’s Disease,” added Prof Takeshi Iwatsubo, Head of the Department of Neuropathology, Graduate School of Medicine, at The University of Tokyo, and principal investigator of J-ADNI.
About [F18] MK-6240
MK-6240 is an investigational imaging agent, in Positron Emission Tomography (PET) scans to assess the status and progression of neurofibrillary tangles (NFTs) in the brain. NFTs made up of aggregated tau protein are a hallmark of several neurodegenerative diseases, including Alzheimer’s Disease.
About Cerveau Technologies, Inc.
Cerveau Technologies, Inc. is a collaboration between Enigma Biomedical Group, Inc. and Sinotau Pharmaceutical Group. Cerveau's vision is to globally develop diagnostics and technology that positively impact patients with neurodegenerative disorders including Alzheimer's Disease.