• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Immunicon Corporation to Conduct Circulating Tumor Cell Testing for Breast Cancer Clinical Trial Conducted By the Southwest Oncology Group

Posted on: Tuesday, 28 November 2006, 09:01 CST

Immunicon Corporation (NASDAQ-GM:IMMC) announced today that a major clinical trial conducted by the Southwest Oncology Group (SWOG) has opened to enrollment. The trial is a randomized Phase III trial designed to determine whether changing cancer therapy when circulating tumor cells (CTCs) are elevated at the first follow-up assessment will improve the survival time of the patients. Women with confirmed breast cancer and clinical evidence of metastatic disease who are entering their first line of chemotherapy are eligible to participate.

Jeffrey B. Smerage M.D., Assistant Professor of Medicine at the University of Michigan Comprehensive Cancer Center and principal investigator for the study, commented, "The SWOG study is a natural extension of the pivotal trial that Immunicon conducted for FDA clearance. The original study demonstrated that CTCs can be used to predict survival at multiple time points during therapy. The data suggests that effective therapy that eliminates circulating tumor cells does indeed positively impact survival. This SWOG study is expected to give us a definitive answer to the following question: "Does changing cancer therapy when CTCs are elevated make a difference in the survival of patients with metastatic breast cancer?"

Immunicon will perform CTC testing for hundreds of sites who elect to participate in the trial. Byron Hewett, president and chief executive officer of Immunicon, commented, "In preparation for the start of this trial, we have completed all requirements for certification under the Clinical Laboratory Improvement Amendment (CLIA) and our laboratory is now licensed to conduct tests that are categorized as highly complex under CLIA regulations. Unlike our own FDA trials and the studies for pharmaceutical companies we have conducted to date, the CTC results for the SWOG trial will be used to make treatment decisions, which drove the decision to complete the CLIA certification process."

SWOG is one of the largest cancer clinical trials cooperative groups in the United States. Funded by research grants from the National Cancer Institute, SWOG conducts clinical trials to prevent and treat cancer in adults and to improve the quality of life for cancer survivors. SWOG has approximately 120 clinical trials underway at this time. SWOG's network of more than 5,000 physician-researchers practice at nearly 550 institutions, including 17 of the National Cancer Institute's 61 designated cancer centers, university teaching hospitals, community hospitals, community-based physician cooperatives and individual physician offices.

About Immunicon Corporation

Immunicon Corporation is developing and commercializing proprietary cell- and molecular-based human diagnostic and life science research products, and is providing certain analytical services to pharmaceutical and biotechnology companies to assist them in developing new therapeutic agents, with an initial focus on cancer disease management. Immunicon has developed platform technologies to identify, count and characterize a small number of rare cells in blood, such as circulating tumor cells and circulating endothelial cells that are important in many diseases and biological processes. Immunicon's products and underlying technology platforms also have application in cancer research and may have applications in other fields of medicine, such as cardiovascular and infectious diseases. For more information, please visit www.immunicon.com.

Forward-Looking Statements

This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often preceded by words such as "hope,""may,""believe,""anticipate,""plan,""expect,""intend,""assume,""will" and similar expressions. Forward-looking statements contained in this press release include, among others, statements relating to the anticipated clinical utility of Immunicon's products and other statements not of historical fact. Immunicon cautions investors not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release, are based on the current expectations and intent of the management of Immunicon and involve certain factors, such as risks and uncertainties that may cause actual results to be far different from those suggested by these statements. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict, including, but not limited to, risks and uncertainties associated with: Immunicon's dependence on Veridex, LLC, a Johnson & Johnson company, in the field of cancer cell analysis; the ability to earn license and milestone payments under Immunicon's agreement with Veridex; Immunicon's capital and financing needs; research and development and clinical trial expenditures; commercialization of product candidates; Immunicon's ability to obtain licenses from third parties to commercialize products; Immunicon's ability to manage its growth; obtaining necessary regulatory approvals; reliance on third party manufacturers and suppliers; reimbursement by third party payors to Immunicon's customers; compliance with applicable manufacturing standards; retaining key personnel; delays in the development of new products or planned improvements to products; effectiveness of products compared to competitors' products; protection of Immunicon's intellectual property; conflicts with third party intellectual property; product liability lawsuits that may be brought against Immunicon; labor, contract or technical difficulties; and competitive pressures in Immunicon's industry. These factors are discussed in more detail in Immunicon's filings with the Securities and Exchange Commission. Except as required by law, Immunicon accepts no responsibility for updating the information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise, or for modifications made to this document by Internet or wire services.

"Immunicon" and the Immunicon Corporation logo are registered trademarks of Immunicon Corporation. ALL RIGHTS RESERVED.

Source: Business Wire

More News in this Category