Healthcare Industry News: CellSearch
News Release - December 3, 2007
Immunicon Corporation Announced the Filing for FDA Clearance of the CellSearch(TM) Circulating Tumor Cell Kit for Monitoring Patients with Metastatic Androgen-Independent Prostate CancerHUNTINGDON VALLEY, Pa.--(HSMN NewsFeed)--Immunicon Corporation (NASDAQ-GM:IMMC) announced today that it filed with the FDA a request for clearance of the CellSearch™ Circulating Tumor Cell Kit as an aid in the monitoring of patients with metastatic androgen-independent prostate cancer.
Immunicon announced that it had successfully met the primary endpoint associated with its pivotal clinical trial in metastatic androgen-independent prostate cancer in January 2007. The primary endpoint required demonstrating that circulating tumor cells (CTC) levels three-to-five weeks after the initiation of chemotherapy predict overall survival.
The study results which were presented by Jose Moreno, MD, clinical associate professor of Urology at Thomas Jefferson University at the 43rd Annual American Society of Clinical Oncology (ASCO) meeting in June also showed that CTC levels predict overall survival at each of the additional monthly time points tested. Results showed that serial CTC measurement before and after initiation of therapy in men with androgen-independent prostate cancer delivered more reliable information about disease progression and patient survival months earlier than the traditional measurement of changes in Prostate-Specific Antigen (PSA) measurements.
Byron D. Hewett, CEO and President of Immunicon Corporation commented, "Research and clinical testing have continued to prove the effectiveness and impact the CellSearch™ Circulating Tumor Cell Test can have in the treatment of patients with metastatic disease. With CellSearch’s current FDA clearances for breast and colorectal cancers, adding the clearance for metastatic androgen-independent prostate cancer potentially will provide oncologists and pharmaceutical companies an additional tool to develop therapeutics and improve patient care for three of the top carcinomas.”
For more details on the results of this prostate cancer trial, please refer to the press release section of the Immunicon web site 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, developed by Immunicon, is exclusively marketed by Veridex, LLC, in the cancer field.
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. For more information, visit www.immunicon.com.
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 “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 Immunicon’s key product and clinical development programs, the anticipated clinical utility of Immunicon’s products, and other statements not of historical fact. Immunicon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Forward-looking statements speak only as of the date of this press release, reflect management’s current expectations and involve certain factors, such as risks and uncertainties that may cause actual results to be far different from those suggested by Immunicon’s forward-looking statements. These factors include, but are 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 risks and uncertainties associated with the arbitration proceeding with Veridex given Immunicon’s dependence on Veridex; Immunicon’s capital and financing needs; research and development and clinical trial expenditures; commercialization of Immunicon’s product candidates; Immunicon’s ability to use licensed products and to obtain new licenses from third parties; 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 for Immunicon’s products; risks and uncertainties associated with Immunicon’s outstanding convertible notes and warrants; compliance with applicable manufacturing standards; the ability to earn license and milestone payments under Immunicon’s agreement with Veridex; retaining key management or scientific personnel; delays in the development of new products or to planned improvements to Immunicon’s products; effectiveness of Immunicon’s products compared to competitors’ products; protection of Immunicon’s intellectual property and other proprietary rights; conflicts with the intellectual property of third parties; 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. “CellSearch” is a trademark of Johnson & Johnson. All other trademarks or servicemarks appearing herein are the property of their respective holders. ALL RIGHTS RESERVED.
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