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Biotech / Medical : Immunicon Corporation (IMMC)

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From: tnsaf9/26/2006 6:00:36 PM
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Immunicon Achieves Endpoints in its Pivotal Clinical Trial in Metastatic Colorectal Cancer

HUNTINGDON VALLEY, Pa.--(BUSINESS WIRE)--Immunicon Corporation (NASDAQ-GM:IMMC) announced today that the Company met the primary and secondary endpoints associated with its pivotal clinical trial in metastatic colorectal cancer. The primary endpoint was that the number of circulating tumor cells (CTCs) 3-5 weeks after the initiation of therapy would agree with a patient’s response to therapy as determined by imaging 6-12 weeks after initiation of therapy. The secondary endpoint was that the number of CTCs prior to and after the initiation of therapy would predict the clinical end points of progression-free survival and overall survival.

The prospective, multi-center trial was designed for longitudinal enumeration of CTCs in patients with metastatic colorectal carcinomas measurable by imaging. A total of 481 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 CellTracks® technology. Patients remained on the study and provided blood for up to 12 months or until documented evidence of disease progression and/or death.

Leon Terstappen, MD, PhD, senior vice president and chief scientific officer of Immunicon commented, “We are pleased that the data in colorectal cancer are consistent with those in breast cancer and broadens the clinical utility of our products. We expect to submit the data to the FDA and for scientific presentations and publications by the end of this year.”
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