CellSearch™ Circulating Tumor Cell Kit Receives FDA
Clearance for Monitoring Patients with Metastatic Colorectal Cancer Data is consistent with that seen in breast cancer and broadens the clinical
utility of the CellSearch test
Huntingdon Valley, PA, November 26, 2007 – Immunicon Corporation (NASDAQ-GM:IMMC)
announced today 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.
The information contained in this press release includes “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements are often preceded by words such as
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“will” and similar expressions. Forward-looking statements contained in this
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& Johnson company, in the field of cancer cell analysis; the risks and
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“Immunicon” and the Immunicon Corporation logo are registered trademarks of
Immunicon Corporation. “CellTracks” is a registered trademark of Immunivest
Corporation, a wholly-owned subsidiary of Immunicon Corporation. “CellSearch” is
a trademark of Johnson & Johnson. All other trademarks or servicemarks appearing
herein are the property of their respective holders. ALL RIGHTS RESERVED.
Contact Information:
James G. Murphy
SVP of Finance & Administration, CFO
215-346-8313
jmurphy@immunicon.com
Investors/Media:
Tierney Communications
Denise Portner
Vice President
215-790-4395
dportner@tierneyagency.com