Kendle, a global full-service clinical research organization, today announced it now offers Brain Network Activation (BNA) imaging providing a non-invasive platform for mapping, monitoring and understanding brain electro-physiological network activity in response to cognitive or physiological stimuli. The BNA imaging technology was developed by ElMindA, a medical technology development company based in Herzliya, Israel. Exclusively licensed to Kendle’s early stage development efforts, this innovative solution reveals electrophysiological neural networks by using an innovative set of signal processing and pattern recognition techniques that combine the high temporal resolution of EEG with the spatial resolution of fMRI.
The result is a three-dimensional image of neuronal connectivity and synchronization providing sensitive, specific and reproducible data on drug effects essential for early stage development.
“This technology represents a sizeable step forward in our ability to evaluate the effectiveness of CNS drugs early in their development by directly and objectively observing the brain’s response to them,” said Ed Sellers, MD, PhD, FRCPC, FACP, Vice President, Early Stage, Kendle.
“BNA is faster, less expensive and more accessible than other brain imaging solutions currently on the market because all scanning can be done in house. Ultimately this translates into powerful, abundant data and expedited go/no-go decisions for our customers, saving them time and money.” The BNA technology utilizes standard 64 electrode EEG and can be applied in any clinic by an EEG-trained technician rather than requiring scanning time in MRI machines. There are no limits to the number of scans or images that can be taken over a set amount time as EEG is completely non-invasive, allowing for assessments at multiple time points and multiple doses to determine the effects of novel drugs on brain function.
“ElMindA’s mission in developing BNA imaging was to revolutionize the diagnosis and treatment of brain-related pathologies by showing, for the first time, the dynamic connectivity and synchronization of electrophysiological networks within the brain,” said Professor Amir Geva, Founder and Chief Technology Officer of ElMindA. “We are enabling researchers and physicians to truly observe the direct electrophysiology of the brain reacting to treatment in order to improve a wide range of therapies. Kendle was the ideal partner to bring this exclusive technology to market because of their extensive early stage CNS experience.” The BNA technology is expected to accelerate research in such key areas as Alzheimer’s disease, mild cognitive impairment, schizophrenia, pain, ADHD, depression, anxiety, sleep disorders and narcolepsy and can be adapted to any study of drugs expected to act on the central nervous system. BNA is ideal for SAD/MAD discovery, proof-of-concept and proof-of-mechanism studies, patient bridging and identifying select responder populations. The highly-sensitive imaging also can capture dose-dependent changes in the brain, allowing for evaluation of drug-drug interactions and improved participant selection criteria.
“The technology has been targeted to early stage CNS drugs very early in their development, allowing us to literally see if and how a drug is working by evaluating cognition or subjective measures of response coupled with network activation patterns,” noted Dr. Sellers.
BNA technology is available immediately to Kendle customers through the Company’s early stage units in Toronto, Canada and Utrecht, The Netherlands. Kendle is a worldwide leader in early stage clinical development, providing high-end scientific exploratory/translational medicine expertise from first-in-human studies through Phase IIa/proof-of-concept. The Company offers unrivalled expertise in the conduct of studies involving the measurement of pharmacodynamic parameters, particularly in drugs acting on the Central Nervous System. Kendle’s early stage core competencies include neurocognitive assessment, abuse liability assessment and pharmacogenomics. The Company’s offerings also include bioequivalence and bioavailability services for customers in the generics industry.
