ACLA Aclara Biosciences, (MM)

ACLARA Data at EORTC-NCI-AACR Symposium Demonstrates ETAG(TM) System Potential in Cancer Drug Development and Treatment Prognosis MOUNTAIN VIEW, Calif. and GENEVA, Sept. 30 /PRNewswire-FirstCall/ -- ACLARA BioSciences (NASDAQ:ACLA) today announced that researchers presented four posters at the EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer Therapeutics" in Geneva, Switzerland. The posters demonstrate the capabilities of the company's eTag(TM) System to selectively and quantitatively detect various protein-protein interactions involved in the aberrant activation of tyrosine kinase, a receptor which when activated is highly correlated to cancer cell proliferation, tumor growth and ultimately to poor patient prognosis. "These posters provide an overview of the potential of the eTag System to improve the management of cancer by facilitating individualized treatment based on the specific molecular phenotype of the patient's tumor," commented Sharat Singh, Ph.D., ACLARA's chief technical officer. "We show for the first time that eTag assays can provide quantitative information about receptor dimerization patterns in breast and lung cancer. In addition, the ability of the eTag System to assess the potency of various anti-tumor compounds in development is addressed." ACLARA's eTag assays enable detailed analysis of protein drug targets and signaling pathways in cancer cells. Of note, the assay can be performed on samples that are formalin-fixed, paraffin-embedded, the standard format of tissue preparation employed in most pathology labs. In an environment where small molecule inhibitors and antibody therapeutics are increasingly available for the treatment of cancer, the eTag System may enhance the ability of the physician to identify patients who are likely to respond to specifically-targeted therapies, as well as streamline patient selection for clinical trials, resulting in potential cost savings and accelerated pace of drug development. Poster Details 1. "IC50 determination for HER family receptor-targeted compounds and downstream signaling." Hossein Salimi-Moosavi, Jin Xueguang, Youssouf Badal , Sailaja Pidaparthi, Yining Shi, Hasan Tahir, Hrair Kirakossain, and Sharat Singh (Poster # P 083877) This poster demonstrates that utilizing the multiplexed eTag Assay System for the detection of receptor dimerization, phosphorylation, and signaling pathway activation can serve as a reliable tool for the screening of cancer drug candidates in a rapid and efficient manner as compared to other currently existing methods. Specifically, the authors looked at the activity of 12 targeted cancer drug candidates currently in development that are believed to inhibit the phosphorylation of tyrosine kinases at the receptor level as well as downstream signaling pathways. The researchers showed that the drug candidates achieved varying degrees of inhibition of phosphorylation of tyrosine kinases and downstream mediators, and therefore concluded that the ability of these drug candidates to inhibit cell proliferation and tumor growth may vary significantly. 2. "Differential HER family receptor dimerization and downstream signaling in cancer cell lines." Hossein Salimi-Moosavi, Xueguang Jin, Youssouf Badal, Tina Tian, Sailaja Pidaparthi, Jing Wei, Caroline Samain, Hasan Tahir, Hrair Kirakossian, and Sharat Singh. (Poster # P 083876) ACLARA scientists developed multiplexed proximity-based eTag assays for the assessment of HER family receptor dimerization and signaling pathway activity (phosphorylation) to streamline analyses of in vitro and in vivo models of cancer. The analysis demonstrates unique signaling patterns that are a function of differential EGFR, HER2 or HER3 receptor expression in various cancer cell lines, and establishes the validity of using the eTag Assay System for signaling pathway profiling. 3. "Development of Proximity based assay to detect and quantify erbB (or HER) receptor dimerization in formalin fixed-paraffin embedded tissue sections." R. Dua, Y. Shi, A. Mukherjee, S. Pidaparthi, H. Kirakossian, L. Cao, Y. Tan, L. Jarvis, S. Gangakhedkar, H. Pannu, A. Chenna, T. Nguyen, J. Wallweber, H. Tahir, and S. Singh. (Poster # P 083879) The eTag system can be used to determine the activation status of the erbB/HER receptor pathway in formalin-fixed, paraffin-embedded (FFPE) clinical samples for the purpose of correlating pathway activation with disease prognosis and probability of response to targeted therapies. Over-expression of erbB/HER receptors in a number of cancers is highly correlated with disease progression and poor prognosis. However, recent clinical trials have shown that over-expression of erbB receptors alone is not sufficient to predict clinical outcome. A thorough analysis of the activation status of the erbB pathway may lead to more accurate targeting of specific antagonists. The eTag System is simple, sensitive, and provides a quantitative assessment of HER-family protein dimerization using FFPE specimens. 4. "Prevalence of erbB/HER receptor dimerization in breast and lung cancer." Sailaja Pidaparthi, Jing Wei, Caroline Samain, Yining Shi, Jerry Wallweber, Ahmed Chenna, Hasan Tahir, and Sharat Singh (Poster # P 083878) Increases in erbB/HER dimerization levels are associated with increased tyrosine kinase activity resulting in uncontrolled cell proliferation and inhibition of apoptosis. ACLARA scientists developed eTag assays to detect and quantify the different types of erbB/HER dimers that are found in breast and lung cancer tissues. The poster demonstrates that eTag technology may serve as a valuable prognostic and diagnostic tool by helping to select patients with breast or lung cancer for targeted therapy, as well as assessing the efficacy of treatment by accurately measuring the activation state of the receptor during therapy. This assay system represents the first quantitative method for the assessment of activation signatures of the erbB/HER family of receptors. Researchers found that all tumor samples had higher HER-2 levels compared to normal breast samples, but ErbB/HER dimerization was detected in tumor tissues only -- not in normal breast tissues, whether matched with the same donor or not. ETag quantitative dimerization assays showed the presence of differential amounts of HER-1/2 and/or HER-2/3 and/or HER-2/2 dimers in different breast cancer tissues of either ductal or lobular types. Similarly, lung tumor samples showed heterogeneous dimerization profiles from patient to patient. About ACLARA Founded in 1995, ACLARA is a biotechnology company working to provide physicians and researchers products and services to make personalized medicine a reality through its protein-based assay technology -- the eTag(TM) System. ACLARA is dedicated to unlocking the power of pathway biology to accelerate the development of next-generation targeted therapeutics, recognizing the most appropriate patients for approved therapies and identifying the highly-specific, protein-based biomarkers that will enable physicians to create truly personalized treatment regimens for patients suffering from cancer and other life-threatening disorders. ACLARA is commercializing its proprietary eTag System to enhance and accelerate drug discovery research and the preclinical and clinical development of targeted therapeutics. ACLARA's technology may also enable the development of highly specific, protein-based diagnostics capable of providing physicians with a powerful tool for creating personalized treatment regimens for patients suffering from serious and difficult-to-treat cancers. For more information on ACLARA please visit the Company's web site at http://www.aclara.com/. Forward-Looking Statements All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934 as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for ACLARA from those projected. Those factors include risks and uncertainties relating to the performance of our products, anticipated progress in commercialization of our eTag(TM) Assay System; the potential for use of our eTag assays in clinical development programs; the potential for use of our eTag assays as diagnostic tests; our ability to successfully conduct clinical studies and the results obtained from those studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; actual market acceptance of our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; our ability to develop organizational capabilities suitable for the further development and commercialization of our eTag assays; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; technological approaches of ACLARA and our competitors; our pending merger with ViroLogic, Inc., including the risk that the closing conditions or the merger may not be satisfied and the merger may not be completed, and costs related to the proposed merger; and other risk factors identified in our Form 10-Q for the quarter ended June 30, 2004 and in the Joint Proxy/Prospectus related to our proposed merger as filed with the Securities and Exchange Commission. NOTE: ACLARA BioSciences is a registered trademark, and eTag and the ACLARA logo are trademarks of ACLARA BioSciences, Inc. DATASOURCE: ACLARA BioSciences, Inc. CONTACT: Alfred Merriweather, VP, Finance and CFO of ACLARA, +1-650-210-1200, or Web site: http://www.aclara.com/

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