CellSearch Circulating Tumor Cell Kit For Monitoring Patients With Metastatic Androgen-Independent Prostate Cancer Applied For FDA Clearance

Main Category: Prostate / Prostate Cancer
Also Included In: Cancer / Oncology
Article Date: 05 Dec 2007 - 3:00 PST

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Immunicon Corporation (NASDAQ-GM:IMMC) announced that it filed with the FDA a request for clearance of the CellSearch Circulating Tumor Cell Kit as an aid in the monitoring of patients with metastatic androgen-independent prostate cancer.

Immunicon announced that it had successfully met the primary endpoint associated with its pivotal clinical trial in metastatic androgen-independent prostate cancer in January 2007. The primary endpoint required demonstrating that circulating tumor cells (CTC) levels three-to-five weeks after the initiation of chemotherapy predict overall survival.

The study results which were presented by Jose Moreno, MD, clinical associate professor of Urology at Thomas Jefferson University at the 43rd Annual American Society of Clinical Oncology (ASCO) meeting in June also showed that CTC levels predict overall survival at each of the additional monthly time points tested. Results showed that serial CTC measurement before and after initiation of therapy in men with androgen-independent prostate cancer delivered more reliable information about disease progression and patient survival months earlier than the traditional measurement of changes in Prostate-Specific Antigen (PSA) measurements.

Byron D. Hewett, CEO and President of Immunicon Corporation commented, "Research and clinical testing have continued to prove the effectiveness and impact the CellSearch™ Circulating Tumor Cell Test can have in the treatment of patients with metastatic disease. With CellSearch's current FDA clearances for breast and colorectal cancers, adding the clearance for metastatic androgen-independent prostate cancer potentially will provide oncologists and pharmaceutical companies an additional tool to develop therapeutics and improve patient care for three of the top carcinomas."

The CellSearch Circulating Tumor Cell Kit, developed by Immunicon, is exclusively marketed by Veridex, LLC, in the cancer field.

About Immunicon Corporation

Immunicon Corporation is developing and commercializing proprietary cell- and molecular-based human diagnostic and life science research products with an initial focus on cancer disease management. Immunicon has developed platform technologies for selection and analysis 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 the clinical development of cancer drugs and in cancer research and may have applications in other fields of medicine, such as cardiovascular and infectious diseases.

Immunicon Corporation