Immunicon Corp. (fka IMMCQ)

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Immunicon Corporation Announces FDA Clearance of the CellSearch(TM) Circulating Tumor Cell Kit for Monitoring Patients with Metastatic Prostate Cancer
Wednesday February 27, 6:06 pm ET
Diagnostic Test Is Now Cleared for Three of the Four Most Common Cancers

HUNTINGDON VALLEY, Pa.--(BUSINESS WIRE)--Immunicon Corporation (NASDAQ:IMMC - News) announced today that the FDA has cleared the CellSearch™ Circulating Tumor Cell (CTC) Kit as an aid in the monitoring of patients with metastatic prostate cancer. A sample of the patient’s blood is processed with the CellSearch Kit using the CellTracks® System to capture and count CTCs. This clearance represents another expansion to claims for the kit, which is now cleared for three of the four most prevalent cancers. The CellSearch CTC kit was originally cleared in January 2004 to predict progression-free and overall survival in patients with metastatic breast cancer and later expanded to include monitoring. In November 2007, the kit was cleared by the FDA for monitoring metastatic colorectal cancer.

Byron D. Hewett, CEO and President of Immunicon Corporation, commented, "Because the three pivotal trials demonstrated that the CellSearch test predicts survival in prostate, breast and colorectal cancers, circulating tumor cell testing should become standard of care in the management of patients with metastatic disease. We estimate the market size for testing in these three cancers is almost $1 billion. More importantly, oncologists can use the results to make better-informed treatment decisions and improve patient care for three of the top carcinomas.”

THE IMPACT

According to the American Cancer Society, prostate cancer claims approximately 27,000 lives each year, the vast majority of which are a result of recurrent metastatic disease. Metastatic prostate cancer occurs when tumor cells spread to other locations in the body and grow. Evaluation of CTC count at any time during the treatment of metastatic disease allows assessment of patient prognosis and predicts survival. Oncologists often have to wait several months before they can determine if a specific treatment is beneficial to the patient. Changes in CTC count can be assessed in 3-5 weeks, rather than in the 8-12 weeks required for imaging studies such as CT scans. The results of serial CTC testing can help physicians assess disease progression, thereby guiding more informed patient care decisions earlier.

THE RESULTS

The study demonstrated that a threshold of 5 CTC / 7.5 mL stratifies androgen independent prostate cancer patients into two distinct groups based on comparison to overall survival (OS). Patients with 5 or more CTCs at baseline and at 3-4 weeks after the initiation of chemotherapy have significantly shorter OS than patients with less than 5 CTCs. The presence of CTCs at any time during the course of the disease is a strong independent predictor of OS. The CellSearch test provides more reliable and informative results regarding the biological activity of the individual patient’s disease status than do measurements of PSA. Although a reduction of PSA at some points after initiation of therapy may reach significance for prediction of survival, favorable CTC at any time point were more accurate than the PSA evaluation. The practical implication is the use of CTC analysis for the evaluation of the probability of survival of patients with metastatic prostate cancer. In cases where CTC and PSA change were discordant, CTC change provided the most accurate assessment of prognosis.

Finally, the fundamental principles of tumor biology upon which the CellSearch test is based are common to all three diseases. Consequently, results from each study demonstrate that a CTC threshold exists in these carcinomas and can be used to stratify patients based on the demonstrated agreement of CTC with the true clinical end point overall survival.

For more details on the results of this prostate cancer trial, please refer to the press release section of the Immunicon web site (immunicon.com) and download the release entitled "Immunicon Achieves Endpoint in its Pivotal Clinical Trial in Metastatic Androgen Independent Prostate Cancer" posted on January 18, 2007.

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