VLGC Virologic (MM)

Study Demonstrates ViroLogic's eTag System Can Measure Activated VEGF Receptor, Target for Anti-Angiogenic Treatments -Abstract #9595- ORLANDO, Fla., May 15 /PRNewswire-FirstCall/ -- ViroLogic, Inc., (NASDAQ:VLGC) announced today the presentation of data demonstrating the ability of the company's eTag(TM) Assay System to provide a direct measure of activated Vascular Endothelial Growth Factor (VEGF) receptor type 2 (VEGFR2, also known as KDR), and its effects on downstream signal transduction pathways in an in vitro model system. The presentation took place at the 2005 American Society of Clinical Oncology (ASCO) Annual Meeting being held this week at the Orange County Convention Center in Orlando, FL. Currently, there is no direct method of detecting activated VEGFR2, and an assay able to measure this, and potentially indicate its contribution to tumor blood vessel development in individual patients, could aid in the prescription of anti-angiogenic therapies. Angiogenesis is the process by which new blood vessels are generated in the body and are directed to tissues undergoing rapid growth or in need of additional nutrients. It is a critical factor in tumor growth and metastasis because tumor cells divide and grow very rapidly, and typically secrete angiogenic factors to ensure an adequate blood supply. There are a number of peptide and protein factors that stimulate angiogenesis and a key one is VEGF, which acts through the VEGFR2 receptor. Much effort is being directed toward blocking VEGF, VEGFR2 and other angiogenic signaling pathways in different types of cancer with targeted therapeutics such as monoclonal antibodies like Avastin(R) (bevacizumab), approved for use in colon cancer and exhibiting clinical activity in studies in lung and breast cancer, as well as small molecule VEGFR2 kinase inhibitors that are still in development. "Our data in these cell lysate studies show that the eTag assay gives a direct measure of the activation of VEGFR2 and the signaling pathway it modulates," said Sharat Singh, Ph.D., ViroLogic's Chief Technical Officer, Oncology, and co-author of the study. "We are currently utilizing very similar eTag assays for activated EGFR receptors with human clinical samples. We feel that the VEGFR2 assay could also be used in this setting, first as a selection tool to determine whether a VEGF pathway inhibitor, like Avastin, is an appropriate therapy for a patient, and then potentially to measure modulation of activated VEGFR2 as a marker for efficacy of certain angiogenesis inhibitors." "Our work on clinical tumor samples to date with eTag assays has focused on activated EGFR and HER receptors, which we expect to be the focus of our first commercial oncology product," said William D. Young, Chairman and CEO of ViroLogic. "This early cell lysate work in the VEGF receptor family indicates the potentially broader reach of our technology, where receptor activation through protein complex formation is a key feature of the biology." Researchers at ViroLogic stimulated Human Umbilical Vein Endothelial Cells with increasing concentrations of VEGF for different periods of time. The eTag assays were used to detect VEGFR2 homodimers, VEGFR2 phosphorylation, and downstream pathway activation in whole cells lysates. The downstream proteins assayed in the signal transduction pathway stimulated by VEGF included Erk, BAD, RSK, and Akt. The level of VEGFR2 homodimers was found to increase with increasing doses of VEGF. Phosphorylation of VEGFR2 was transient, peaking at one minute of VEGF treatment and falling to background level after five minutes. One minute dosing of VEGF showed increasing VEGFR2 phosphorylation with increasing levels of VEGF. Downstream pathway proteins Erk, RSK, and BAD were activated with increasing levels of VEGF. About the eTag System ViroLogic's eTag assays enable detailed analysis of protein drug targets and signaling pathways in cancer cells, including samples that are formalin- fixed, paraffin-embedded, which is the standard format in most pathology labs. The assays can provide information on a drug's mechanism of action, selectivity and potency in a biological setting in pre-clinical research, and enable enrichment or selection of clinical trial populations later in a drug's development. In addition, ViroLogic believes these assays may ultimately be used to help physicians better determine whether certain therapies are more appropriate for individual cancer patients, and whether to combine therapies with different mechanisms or properties. The first commercially available activated receptor test panel based on eTag technology, focused on the EGFR/HER receptor family, is planned to be introduced in 2006. About ViroLogic ViroLogic is a biotechnology company advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at http://www.virologic.com/. FORWARD-LOOKING STATEMENTS Certain statements in this press release are forward-looking, including statements regarding the trend toward individualized medicine and the results of yet-to-be completed clinical studies related to the effectiveness of our eTag assays as predictive tools for targeted cancer therapies. These forward- looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties relating to the development of future products; the performance of our products; our ability to successfully conduct clinical studies and the results obtained from those studies; whether larger confirmatory clinical studies will confirm the results of initial studies; whether larger studies involving tumor samples will yield favorable results regarding the predictive capability of eTag assays for responsiveness to Avastin or other VEGF inhibitors; our ability to establish reliable, high-volume operations at commercially reasonable costs; our ability to introduce a product commercially in 2006; our ability to successfully integrate the operations of ACLARA into our operations; competition from larger more established diagnostic providers; 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 level of demand for our products; the timing and ultimate size of pharmaceutical company clinical trials; whether payors will authorize reimbursement for our products; whether the FDA or any other agency will seek to regulate ViroLogic's in house clinical laboratory testing; our ability to comply with FDA regulations in order to establish and maintain diagnostic kit manufacturing operations; whether we will encounter problems or delays in establishing and validating eTag assays within our clinical laboratory; whether we will encounter problems or delays in automating our processes or expanding our capacity; whether the intellectual property underlying the Company's technology is adequate; whether we may be deemed to infringe on the intellectual property of others and whether licenses to third party technology will be available; whether ViroLogic is able to build brand loyalty and expand revenues; the potential impact of any payments under the CVRs on our common stock and capital resources; and whether ViroLogic will be able to raise sufficient capital when required. For a discussion of other factors that may cause ViroLogic's actual events to differ from those projected, please refer to the Company's most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. We do not undertake, and specifically disclaim any obligation, to revise any forward looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements. eTag is a trademark of ViroLogic, Inc. Avastin(R) is a registered trademark of Genentech. DATASOURCE: ViroLogic, Inc. CONTACT: Alfred Merriweather, Vice President and CFO of ViroLogic, +1-650-635-1100; or Carolyn Bumgardner Wang of WeissComm Partners, +1-415-225-5050, , for ViroLogic Web site: http://www.virologic.com/

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