Kendle Advances Early Stage Drug Development with ElMindA's Innovative Brain Network Activation Technology
CINCINNATI, June 15 Kendle (Nasdaq: KNDL), a leading, 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.
ElMindA Ltd. develops and markets a non-invasive, diagnosis and treatment management platform that addresses a critical unmet need in neurological and psychiatric disorders to dramatically enhance treatment efficacy and patients' quality of life while reducing costs. ElMindA's mission is to revolutionize the treatment of brain-related pathologies by revealing, for the first time ever, the dynamic electrophysiological neural network connectivity and synchronization of the brain, paving the way to affecting brain plasticity and empowering the dramatic improvement of brain disorder treatment at any neurological and psychiatric point of care. ElMindA's platform can be utilized for a wide range of neurological and psychiatric applications and is currently available for clinical development. ElMindA is located at 16 Haminhara St., Beit Bachar Herzliya 46586, Israel. For more information visit www.elminda.com.
Kendle International Inc. (Nasdaq: KNDL) is a leading global clinical research organization providing the full range of early- to late-stage clinical development services for the world's biopharmaceutical industry. Our focus is on innovative solutions that reduce cycle times for our customers and accelerate the delivery of life-enhancing drugs to market for the benefit of patients worldwide. As one of the world's largest global providers of Phase I-IV services, we offer experience spanning more than 100 countries, along with industry-leading patient access and retention capabilities and broad therapeutic expertise, to meet our customers' clinical development challenges.
Additional information and investor kits are available upon request from Kendle, 441 Vine Street, Suite 500, Cincinnati, OH 45202 or from the Company's Web site at www.kendle.com.
Certain statements and information contained in this press release may be deemed to be forward-looking statements under federal securities laws and the provisions of the Private Securities Litigation Reform Act of 1995 and Kendle intends that such forward-looking statements be subject to the safe-harbor created thereby. All such forward-looking statements, including those regarding the benefits of Kendle's use of ElMindA Brain Network Activation technology are based largely on management's expectations and are subject to and qualified by risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those risks as detailed from time to time in Kendle's Annual Report on Form 10-K as well as periodic reports filed with the SEC. All information in this press release is current as of June 15, 2010. The Company undertakes no duty to update any forward-looking statement to conform the statement to actual results or changes in the Company's expectations.
SOURCE Kendle International Inc.
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