ACLA Aclara Biosciences, (MM)

Clinical Data Presented at ESMO Shows ETAG(TM) System's Potential in Predicting Response to Cancer Treatment MOUNTAIN VIEW, Calif., Nov. 4 /PRNewswire-FirstCall/ -- ACLARA BioSciences (NASDAQ:ACLA) today announced that Sharat Singh, Ph.D., ACLARA's Chief Technical Officer, presented data from a pilot clinical trial demonstrating the ability of ACLARA's eTag(TM) assays to correctly differentiate responders from non-responders to Herceptin(R) treatment in patients with breast cancer. These data, subject to confirmation in larger, trials, suggest that the eTag System may be more accurate than the current standard at differentiating responders from non-responders to this widely used targeted therapy. Dr. Singh's oral presentation was made at the "Advances in Her2 Profiling" session of the 29th European Society for Medical Oncology (ESMO) Congress held this week in Vienna. "The scientific and clinical oncology community is eager to have biomarkers that accurately predict an individual patient's response to a particular targeted cancer treatment, and the results of this feasibility experiment were well-received at ESMO," said Dr. Singh. "The critical information these biomarkers can potentially offer will contribute to the development of truly personalized medicine. The results of this initial experiment, while involving a limited number of patient samples, demonstrate the potential of eTag(TM) assays to provide this type of vital prognostic information." Dr. Singh's presentation, "The use of ErbB activation status as prognostic markers in breast cancer patients treated with Herceptin(R)", described a set of feasibility experiments which were conducted on blinded sets of formalin-fixed, paraffin-embedded tissue samples from 13 breast cancer patients treated with Herceptin(R) and chemotherapy. All patients were positive for the Her2 receptor, the molecular target of Herceptin(R), as measured by HercepTest(R), one of the standard commercial assays for Herceptin(R) pre-screening, and were consequently treated with Herceptin(R). Nonetheless, 5 of the 13 patients had objective tumor responses, 4 had stable disease, and the remaining 4 had progressive disease. By contrast, the eTag assays, which were designed to measure receptor dimer levels as an indicator of pathway activation as opposed to simple receptor expression, were able to more fully differentiate responders from non-responders. Specifically, medium to high levels of Her2 homodimers as measured by eTag assays had a positive correlation with response, but when coupled with high levels of Her3 heterodimers as measured by eTag assays (a potential biomarker for an alternative growth pathway not blocked by Herceptin(R)) had a negative correlation with response. All 5 patients with objective tumor response had high levels of Her2 homodimers and low levels of Her3 heterodimers. All 4 patients with stable disease had low to medium levels of Her3 heterodimers, while all 4 patients with progressive disease had high levels of Her3 heterodimers. Larger studies are needed to provide additional validation for this approach, and these encouraging results have led ACLARA and the Tokyo Metropolitan Institute of Medical Science (Rinshoken) to collaborate on a larger, confirmatory study, the planning of which is currently underway. 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; whether the results from larger studies will confirm initial results from smaller pilot or feasibility 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 with ViroLogic, Inc. as filed with the Securities and Exchange Commission. Trademarks ACLARA BioSciences is a registered trademark, and eTag and the ACLARA logo are trademarks of ACLARA BioSciences, Inc. Herceptin and HercepTest are registered trademarks of Genentech, Inc. and DakoCytomation, respectively. DATASOURCE: ACLARA BioSciences Inc. CONTACT: Alfred Merriweather, VP, Finance and CFO of ACLARA Biosciences, +1-650-210-1200, or Web site: http://www.aclara.com/

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