ACLA Aclara Biosciences, (MM)

ACLARA BioSciences and Tokyo Metropolitan Institute of Medical Science (Rinshoken) to Conduct Breast Cancer Biomarker Study Focus on Indicators of Herceptin(R) Responsiveness MOUNTAIN VIEW, Calif. and TOKYO, June 14 /PRNewswire-FirstCall/ -- ACLARA BioSciences Inc. (NASDAQ:ACLA) and the Tokyo Metropolitan Institute of Medical Science (Rinshoken) announced today that they have entered into an agreement to collaborate on a study to evaluate breast cancer patient samples to validate candidate biomarkers detected with ACLARA's proprietary eTag(TM) technology. This study follows previously completed feasibility experiments on a small set of tissue samples from patients treated with Genentech's drug Herceptin(R) and chemotherapy. The previous feasibility experiments were conducted on blinded sets of formalin-fixed, paraffin-embedded tissue samples from thirteen breast cancer patients treated with Herceptin and chemotherapy. All patients were positive for the Her2 receptor (HercepTest(R) +3), the molecular target of Herceptin, but not all responded to therapy. In this limited retrospective study, ACLARA's eTag System was significantly better able to differentiate between those patients whose disease had not progressed with treatment from those whose disease had progressed than other methods employed. The encouraging results from these experiments led ACLARA and Rinshoken to plan the larger study covered by the new agreement. As part of the agreement announced today, ACLARA will provide research funding to Rinshoken and will have the ability to develop the biomarkers as clinical diagnostics. Rinshoken's newly established Translational Research Center (TRC) will coordinate the project which is the first collaboration between this organization and a U.S. biotechnology company. Under the agreement, Rinshoken will collect tumor samples and blinded patient data, including treatment histories and outcomes, and ACLARA will test the samples for a variety of parameters that it believes could serve as biomarkers of responsiveness to certain targeted therapies, including Herceptin. The biomarkers under evaluation are proteins and protein complexes and their different functional or activation states that comprise signaling pathways in cells. These pathways enable information transfer within and between cells and control such processes as cell growth, division and death. When these pathways malfunction, the affected cells can become cancerous, dividing uncontrollably. Approved targeted therapies like Herceptin, and many more in development, act on the proteins within these pathways. By measuring the targeted proteins and pathways directly, ACLARA believes it can help physicians better determine whether Herceptin or other therapies are most appropriate for treating an individual cancer patient. "We are very pleased to be collaborating with Rinshoken and its affiliated hospitals," said Thomas Klopack, ACLARA's chief executive officer. "We are very excited about the potential of these candidate biomarkers to help physicians provide better care for patients. The critical information these biomarkers can offer will permit the development of truly personalized medicine. This project has grown from an initial successful feasibility study conducted with Dr. Masakazu Toi at Komagome Hospital (Cancer and Infectious Disease Center), and demonstrates the importance of the link between research and clinical medicine to these types of advances. While the feasibility experiments involved a limited number of patients, the preliminary results are encouraging. The establishment of the Translational Research Center is a progressive step by Rinshoken that will help to ensure that discoveries are rapidly moved from the laboratory bench to the clinic." Dr. Ken-ichi Arai, science advisor and director of Rinshoken, said, "We feel that at this early stage in the TRC's development, it is important for the TRC to initiate projects that have broad implications for medicine and patient care. This project clearly falls into that category." The TRC's director, Dr. Futoshi Shibasaki, commented, "Coordinating a project that involves five different hospitals in the Tokyo Metropolitan government system, as well as Rinshoken, is just the type of translational project the Center was established to conduct. I look forward to a successful outcome, and expect that it will pave the way for other interactions of this type." ACLARA's eTag System is able to identify difficult-to-detect protein complexes that can provide unique insights to the likelihood of particular patients to respond to specific therapies. In addition, since the eTag System can utilize formalin-fixed, paraffin-embedded clinical samples, the standard format in most pathology labs, this enables the analysis of both archived samples from initial biopsies or surgeries as well as freshly collected materials. The samples being evaluated in this study are in the fixed format. About Rinshoken Rinshoken's activities cover a very wide area of clinical medicine and life science research. It has made important contributions through research targeted to investigating the causes as well as the diagnosis, treatment and control of major diseases, including cancer, infectious diseases such as Hepatitis C and genetic diseases. For example, it has aided efforts to control Hepatitis C through important findings on the eradication of the Hepatitis B virus and the first successful imaging of the Hepatitis C virus by electron microscopy. 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 March 31, 2004 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 is a registered trademark of Genentech, Inc. HercepTest is a registered trademark of DakoCytomation. DATASOURCE: ACLARA BioSciences Inc. CONTACT: investor, Alfred Merriweather, VP, Finance and CFO, +1-650-210-1200, or ; or media, Jennifer Viera of Schwartz Communications, +1-781-684-0770, or , for ACLARA BioSciences Inc. Web site: http://www.aclara.com/

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