New Veridex Alliance Drives Study Of Circulating Tumor Cells In Men With Metastatic Prostate Cancer
-- Research will employ the Veridex CELLSEARCH® CTC Test, the only 510(k)-cleared in vitro diagnostic test to capture and count CTCs --
RARITAN, N.J., April 23, 2012 /PRNewswire/ -- Veridex, LLC announced today that it has joined with Novartis Pharmaceuticals Corporation in an educational alliance to encourage and facilitate research involving circulating tumor cells, or CTCs, as a potential biomarker in metastatic prostate cancer.
As part of this initiative, Veridex will support a prospective, single arm, open-label study designed to investigate the effect of zoledronic acid* on CTCs in patients with metastatic castration-resistant prostate cancer (CRPC).
Dr. Ekkehardt Bismarck, M.D., of the EuromedClinic, Furth, Germany, one of the lead investigators, comments, "We hope to determine whether zoledronic acid may have an impact on CTC counts in the body. It is known that improvement of CTC counts has been associated with improved clinical outcomes."
The study population will initially consist of a representative group of 60 CRPC patients with metastatic bone disease from five-to-10 study centers in Germany. The study will investigate the number of CTCs in study patients who receive zoledronic acid 4mg administered every four weeks for three months. The primary objective of the study is to determine the proportion of patients with decreased CTCs at 12 weeks after first infusion of zoledronic acid.
"Our alliance with Novartis further highlights the growing interest in CTCs as a potential biomarker in treating patients with metastatic prostate, breast and colorectal cancers," said Robert McCormack, Ph.D. and Head of Technology Innovation at Veridex. "We look forward to further investigating the potential predictive benefit of CTCs in metastatic prostate cancer clinical studies as there are currently limited ways of assessing therapeutic benefit in this disease, especially when it has metastasized to the bone."
"Our agreement with Novartis signifies our desire to collaborate with biopharmaceutical companies both internally and externally," continued McCormack. "By leveraging our world-leading expertise in rare cell technology and developing current and future collaborations, we can drive to a more informed drug development model and help develop targeted treatments, making a significant difference for patients and their families."
About Circulating Tumor Cells
Circulating tumor cells are cancer cells that have detached from the tumor and are found at extremely low levels in the bloodstream. The potential clinical benefit of capturing and counting CTCs is being investigated as more research data is gathered about the potential utility of these markers in monitoring disease progression and potentially guiding personalized cancer therapy.
About the CELLSEARCH® CTC Test
CELLSEARCH® is the first and only United States Food & Drug Administration 510(k)-cleared in vitro diagnostic (IVD) test to capture and count CTCs to determine the prognosis of patients with metastatic breast, colorectal or prostate cancer. The test can be administered at any time during the course of therapy as a routine blood test. It is used in combination with other tests and a clinician's assessment, to provide a more complete picture of a patient's prognosis.
About Veridex, LLC
Veridex, LLC, a Johnson & Johnson company, is an organization dedicated to providing physicians with high-value diagnostic oncology products. Veridex IVD products may significantly benefit patients by helping physicians make more informed decisions that enable better patient care. Veridex Clinical Research Solutions provide tools and services that may be used for the selection, identification and enumeration of targeted rare cells in peripheral blood for the identification of biomarkers, aiding scientists in their search for new, targeted therapies. For more information, visit www.veridex.com.
*Editor's Note: zoledronic acid is marketed by Novartis as ZOMETA®. For additional information on the safety and efficacy of ZOMETA and the full Prescribing Information, please visit www.zometa.com.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Veridex, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Veridex, LLC nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
SOURCE Veridex, LLC
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