PERCEPTIVE INFORMATICS ENHANCES INVESTIGATOR APPLICATION OF NEW RECIST VERSION IN IMAGING-BASED ONCOLOGY TRIALS
Boston, MA, May 29, 2009 – Perceptive Informatics, the industry’s leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced the launch of a website designed to help investigators apply the new 1.1 version of RECIST (Response Evaluation Criteria In Solid Tumors) in medical imaging-based oncology trials. Perceptive Informatics, which actively participated in the RECIST Working Group, has incorporated into its RECIST website at http://www.recist.com a comparison between RECIST 1.0 and 1.1, as well as instructions on how to effectively use the new criteria.
Medical imaging experts from Perceptive Informatics will be available at Booth #1881 during the American Society of Clinical Oncology (ASCO) Annual Meeting, being held today through June 2, 2009 in Orlando, Florida, to discuss application of the new RECIST 1.1 criteria. These experts will address medical, scientific, and regulatory solutions to improve the use of medical imaging as a surrogate endpoint in oncology trials.
“Independent review using RECIST is an essential part of pivotal oncology trials,” said Kenneth G. Faulkner, Ph.D., Vice President of Medical Imaging, Perceptive Informatics. “With the release of the RECIST 1.1 toolset Perceptive Informatics maintains a leading position with respect to incorporation of the RECIST criteria into Independent Review Charters for regulatory approval of oncology treatments. Perceptive remains at the forefront of incorporating the new RECIST criteria into medical imaging services to meet immediate demand from clients sponsoring oncology trials.”
“Today, the majority of clinical trials evaluating cancer treatments for objective response or progression of disease in solid tumors use RECIST. The new version of RECIST will provide a number of benefits to sponsors including more robust data analysis for patients with certain disease indications as well as the ability to incorporate long-awaited enhancements to evaluate certain types of cancer treatments,” said Oliver Bohnsack, M.D, Medical Director of Oncology for Perceptive Informatics.
Perceptive Informatics 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.
RECIST is a set of published rules that define when cancer patients improve, stay the same, or worsen during treatments. The original criteria were published in February 2000 by an international collaboration including the European Organization for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI) of the United States, and the National Cancer Institute of Canada Clinical Trials Group. RECIST 1.1, published in January 2009, is an update to the original criteria. More information about RECIST can be found at http://www.recist.com and on the EORTC website at http://www.eortc.be/recist.
Information about the ASCO Annual Meeting can be found at: http://www.asco.org/annualmeeting.
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About Perceptive Informatics
Perceptive Informatics, a subsidiary of PAREXEL, is the industry’s leading eClinical solutions provider. Perceptive Informatics offers 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 March 31, 2009 as filed with the SEC on May 8, 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.