Immunicon Achieves Endpoints in Its Pivotal Clinical Trial in Metastatic Colorectal Cancer
Posted on: Tuesday, 26 September 2006, 09:01 CDT
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."
About Immunicon Corporation
Immunicon Corporation is developing and commercializing proprietary
cell- and molecular-based human diagnostic and life science research
products, and is providing certain analytical services to pharmaceutical
and biotechnology companies to assist them in developing new therapeutic
agents, with an initial focus on cancer disease management. Immunicon
has developed platform technologies to identify, count and characterize
a small number 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 cancer
research and may have applications in other fields of medicine, such as
cardiovascular and infectious diseases. For more information, please
visit www.immunicon.com.
Forward-looking Statements
This press release may contain "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 "hope,"
"may,""believe,"
"anticipate,""plan,"
"expect,""intend,"
"assume,""will"
and similar expressions. Forward-looking statements contained in this
press release include, among others, statements relating to the
anticipated clinical utility of Immunicon's
products, expectations of Immunicon's
management with respect to FDA submissions, and other statements not of
historical fact. Immunicon cautions investors not to place undue
reliance on these forward-looking statements, which speak only as of the
date of this press release, are based on the current expectations and
intent of the management of Immunicon and involve certain factors, such
as risks and uncertainties that may cause actual results to be far
different from those suggested by these statements. These statements are
not guarantees of future performance and involve risks and uncertainties
that are difficult to predict, including, but not limited to, risks and
uncertainties associated with: Immunicon's
dependence on Veridex, LLC, a Johnson & Johnson company, in the field of
cancer cell analysis; the ability to earn license and milestone payments
under Immunicon's agreement with Veridex;
Immunicon's capital and financing needs;
research and development and clinical trial expenditures;
commercialization of product candidates; Immunicon's
ability to obtain licenses from third parties to commercialize products;
Immunicon's ability to manage its growth;
obtaining necessary regulatory approvals; reliance on third party
manufacturers and suppliers; reimbursement by third party payors to
Immunicon's customers; compliance with
applicable manufacturing standards; retaining key personnel; delays in
the development of new products or planned improvements to products;
effectiveness of products compared to competitors'
products; protection of Immunicon's
intellectual property; conflicts with third party intellectual property;
product liability lawsuits that may be brought against Immunicon; labor,
contract or technical difficulties; and competitive pressures in
Immunicon's industry. These factors are
discussed in more detail in Immunicon's
filings with the Securities and Exchange Commission. Except as required
by law, Immunicon accepts no responsibility for updating the information
contained in this press release beyond the published date, whether as a
result of new information, future events or otherwise, or for
modifications made to this document by Internet or wire services.
"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. CellTracks Analyzer II is a
trademark of Immunivest Corporation. All other trademarks or
servicemarks appearing in this release are the property of their
respective holders. ALL RIGHTS RESERVED.
Source: Business Wire
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