PERCEPTIVE INFORMATICS INTRODUCES MEDICAL IMAGING METHODOLOGY TO ACCELERATE DEVELOPMENT DECISIONS ABOUT ALZHEIMER?S TREATMENTS
Boston, MA, April 30, 2009 – Perceptive Informatics, the industry’s leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced that it has developed a robust medical imaging methodology for Central Nervous System (CNS) clinical trials involving Alzheimer’s disease. The method, based on measuring ventricular size, provides a new approach to monitor brain atrophy in Alzheimer’s disease and potential treatment effects. The technique was presented on April 26, 2009 in Seattle, Washington during an invitation-only meeting of the Alzheimer’s Disease Neuroimaging Initiative (ADNI).
The advantages of this method include providing higher quality, reproducible, and regulatory compliant assessments with the potential to help clinical trial sponsors make better and faster development decisions about Alzheimer’s treatments in development. To develop this method, the Perceptive Informatics team collected Magnetic Resonance Imaging (MRI) scans from the ADNI database using Perceptive’s medical imaging system and regulatory compliant processes.
“It is more critical than ever that biopharmaceutical companies have the ability to make accurate go/no go decisions as early as possible for new compounds. Medical imaging is increasingly being used as a surrogate endpoint or biomarker of drug efficacy in all phases of CNS trials. With this new methodology, we believe that Perceptive’s therapeutic area experts are able to help sponsors advance neuroimaging and bring important CNS treatments to patients sooner,” said Kenneth G. Faulkner, Ph.D., Vice President of Medical Imaging, Perceptive Informatics.
“Based on ADNI data, measuring ventricular change may be one of the most robust outcomes for imaging progression of Alzheimer’s disease. Perceptive has developed a novel method of ventricular measurement that accurately reflects brain atrophy,” said James Paskavitz, M.D., Medical Director, Perceptive Informatics. “We believe that this method can support sponsors in reducing the time, cost, and risk associated with clinical development of Alzheimer’s treatments by providing medical image data that informs early phase decisions and is reproducible for later phase, multi-center trials.”
The Perceptive Informatics Medical Imaging Group has helped to develop and validate novel surrogate endpoints for a variety of CNS disorders. Perceptive offers a range of capabilities in the application of imaging techniques from early clinical development through late phase studies. The medical imaging team operates globally and services a wide range of therapeutic areas, including oncology, central nervous system, musculoskeletal, cardiovascular, and metabolism/endocrinology imaging.
More information about the Medical Imaging capabilities provided by Perceptive Informatics is available at http://www.perceptive.com/product/imaging/index-medical-imaging.html.
ADNI is focused on defining the rate of progress of mild cognitive impairment and Alzheimer's disease, developing improved methods for clinical trials in this area, and providing a large database to improve design of treatment trials. A goal of ADNI is to provide information and methods to help lead to effective treatments for Alzheimer’s disease, leading to effective prevention. More information about ADNI can be found at http://www.adni-info.org.
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About Perceptive Informatics
Perceptive Informatics, a subsidiary of PAREXEL, is the industry’s leading eClinical solutions provider. Perceptive Informatics offers unprecedented access to innovative eClinical technologies and resources, providing clinical trial sponsors, CROs, and other service providers with the benefits of an extensive line of products and services throughout the entire clinical development lifecycle. In August, 2008 Perceptive was joined with ClinPhone plc, and the newly combined organization offers eClinical software and services that increase the efficiency and productivity of clinical research. Perceptive’s expansive product portfolio includes Interactive Voice and Web Response Systems (IVRS/IWRS), Medical Imaging, Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) and Electronic Patient Reported Outcomes (ePRO) solutions, as well as eClinical systems integration and implementation services. For more information about Perceptive Informatics, visit www.perceptive.com.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 69 locations throughout 52 countries around the world, and has over 9,400 employees. For more information about PAREXEL International visit www.PAREXEL.com.
This release contains "forward-looking" statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business, including, but not limited to, the successful business integration and anticipated synergy achievements in connection with the ClinPhone acquisition; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2008 as filed with the SEC on February 9, 2009, which “Risk Factors” discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company’s estimates as of the date of this release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.
PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.