Clinical Cancer Research Publishes Paper Comparing CTCs to Imaging in Predicting Overall Survival in Metastatic Breast Cancer.

Editorial Calls Reproducibility of CTC Assay "striking"

HUNTINGDON VALLEY, Pa. -- Immunicon Corporation (NASDAQ-GM:IMMC) announced that Clinical Cancer Research published "Circulating Tumor Cells versus Imaging - Predicting Overall Survival in Metastatic Breast Cancer" in the November 1st issue. Principal author, G. Thomas Budd, MD of the Cleveland Clinic Foundation concluded, "Assessment of CTCs is an earlier, more reproducible indication of disease status than current imaging methods. CTCs may be a superior surrogate end point, as they are highly reproducible and correlate better with overall survival than do changes determined by traditional radiology."

In an editorial in the issue, reviewer George W. Sledge, Jr. of the Indiana University Cancer Center said, "The reproducibility of CTC measurement in the Budd study, as opposed to that of standard radiographic techniques, is striking. Assay reproducibility has been the downfall of many a prognostic factor, and the care given to this issue is to be congratulated."

"We are pleased that the work of researchers from major cancer centers across the country has borne out such a clear result," said Leon WMM Terstappen, MD, PhD, Chief Scientific Officer for Immunicon. "It is gratifying that our work in identifying and measuring circulating tumor cells is growing in its clinical applications and supports the important direction to individualize therapy."

Authors of the study noted that the results have implications for both standard care and clinical research: "More accurate determination of treatment effectiveness early in the course of therapy might spare patient toxicity from futile therapy and allow treatment to be changed to a more effective regimen." Co-authors of the study included researchers from M.D. Anderson Cancer Center, Houston; Washington University, St. Louis; University of Arizona, Tucson; University of Michigan Comprehensive Cancer Center, Ann Arbor; and Immunicon Corporation.

Currently, CT scans are used as the standard of care to assess therapy effectiveness. The radiologist measures individual metastatic tumors that appear on film and calculates "tumor burden." Approximately 10 weeks later, the radiologist compares the number and size of tumors to determine if the tumor burden has increased, decreased or stayed the same. In this study, the variability in disease assessment between two expert radiologists' respective analyses was 15.2%. In contrast, disagreement was only 5.6% when the Circulating Tumor Cell results from two blood tubes were compared.

The potential for circulating tumor cells to be the superior surrogate end point was highlighted by the median overall survival of patients with radiologic nonprogression and greater than 5 CTCs which was significantly shorter than that of patients with radiologic nonprogression and fewer than 5CTCs (15.3 versus 26.9 months). In contrast, median overall survival of patients with radiologic progression and fewer than 5 CTCs was significantly longer than for patients with greater than 5 CTCs who showed progression by radiology (19.9 versus 6.4 months).

Reprints of the article may be obtained by contacting G. Thomas Budd, Cleveland Clinic Foundation, at 216-444-6480 or [e-mail]. Reprints of the editorial may be obtained by contacting George W. Sledge Jr, Indiana Cancer Pavilion, at 317-274-0930 or [e-mail].

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.

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