CellSearch™ Circulating Tumor Cell Kit Receives FDA Clearance For Monitoring Patients With Metastatic Colorectal Cancer

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals
Article Date: 27 Nov 2007 - 1:00 PDT

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Immunicon Corporation (NASDAQ-GM:IMMC) announced that FDA clearance has been received for the CellSearch™ Circulating Tumor Cell Kit as an aid in the monitoring of patients with metastatic colorectal cancer. The CellSearch test was originally cleared in 2004 for in vitro diagnostic use in patients with metastatic breast cancer. Serial testing for circulating tumor cell (CTC) count should be used in conjunction with other clinical methods for monitoring colorectal or breast cancer. Evaluation of CTC count at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival. The CellSearch Circulating Tumor Cell Kit, developed by Immunicon, is exclusively marketed by Veridex, LLC, in the cancer field.

The colorectal cancer trial was a prospective, multi-center study designed for longitudinal enumeration of CTCs in patients with metastatic colorectal carcinomas measurable by imaging. A total of 430 evaluable patients were enrolled into the trial between February 2004 and February 2006, from a total of 55 sites in the United States and Europe. Imaging studies were performed prior to the initiation of therapy and at subsequent intervals of approximately 6-12 weeks. CTCs were measured at baseline, 1-2 and 3-5 weeks after the initiation of therapy, and at the time of all subsequent imaging studies (approximately every 6-12 weeks) using Immunicon's CellTracks® technology. Metastatic colorectal cancer patients remained on the study and provided blood for up to 12 months or until documented evidence of disease progression and/or death. Long-term survival information is being obtained on all patients by medical record review at periodic intervals for up to 24 months after study completion.

Consistent with the data in metastatic breast cancer, CTCs predict survival at multiple time points during the course of therapy. Patients with 3 or more CTCs at any of the time points had a much higher likelihood of dying sooner than patients with less than 3 CTCs. For example, at the 3-5 week time point, patients with 3 or more CTCs had a median survival of 4.4 months, whereas patients with less than 3 has median survival of 16.4 months. This represents a 3.7-fold difference in survival.

Furthermore, the trial showed that changes in CTC count during therapy are significant. Patients with 3 or more CTCs prior to treatment who dropped to less than 3 CTCs had a median survival of 11.7 months, which is a significant improvement in survival when compared to patients whose CTC count remained above 3 for the duration of the trial, where the median survival was only 3.9 months. Patients who started with less than 3 and converted to 3 or more CTCs had a median survival of 7.1 months. Patients with less than 3 CTCs throughout the study had the highest median survival (18.6 months).

Leon Terstappen, chief scientific officer of Immunicon commented, "The new FDA-cleared claims in metastatic colorectal cancer are very important because the clinical utility of CTC counts is validated in a second major carcinoma. The CellSearch test represents an additional tool for oncologists to manage their patients with objective information much sooner than currently available CT imaging."

Byron Hewett, president and CEO of Immunicon said, "We are pleased to add another carcinoma claim to the CellSearch™ package insert. We look forward to adding claims in prostate cancer by mid-2008."

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.

http://www.immunicon.com

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