VLGC Virologic (MM)

ViroLogic's eTAG(TM) System Demonstrates Potential Ability to Predict Treatment Outcomes for Colorectal Cancer Patients - Positive Results Indicate High Accuracy and Predictability With eTAG Assay - HOLLYWOOD, Fla., Jan. 27 /PRNewswire-FirstCall/ -- ViroLogic, Inc., (NASDAQ:VLGC) announced today the presentation of clinical data assessing the ability of the company's eTAG(TM) System to accurately predict treatment outcomes for patients with metastatic colorectal cancer. The study, conducted at Princess Margaret Hospital in Toronto, demonstrated that the detection of EGF Receptor family dimers as measured by the eTAG assay correlated with disease stability or disease progression in 18 metastatic colorectal cancer patients being treated with erlotinib (Tarceva(R)). The presentation is titled "Predictive value of eTAG dimerization assay in patients with metastatic colorectal cancer treated with erlotinib," and will be made by Carol Townsley, MD, Clinical Research fellow to Amit Oza, MD, FRCP, Professor of Medicine, Department of Medical Oncology, Princess Margaret Hospital, University of Toronto, working in collaboration with Lillian Siu, MD, FRCPC, at the Gastrointestinal Cancers Symposium, which is co-sponsored by the American Society of Clinical Oncology and is being held in Hollywood, Florida this week. "The new targeted therapies for cancer, such as Tarceva, have great potential, but the molecular diversity of tumors can limit responses to a small percentage of patients," stated Dr. Oza. "I am excited to be involved with eTAG technology as it may allow physicians to identify those patients who are more likely to respond to specifically targeted therapies like Tarceva." In this study, tumor and skin samples were collected from 18 metastatic colorectal cancer patients being treated with a continuous oral dose of erlotinib. Samples were taken prior to treatment and seven days later. Each sample was tested with three different eTAG assays that measured the activity of human epidermal growth factor receptor (EGFR), the molecular target of erlotinib. Dysregulation, or malfunctioning, of EGF receptors is associated with disease progression in cancer patients. eTAG assays performed on samples after one week of treatment with erlotinib demonstrated that the presence of EGFR dimers correlated with outcome in the seven patients who had stable disease and were responding to the erlotinib. Eleven patients had progressive disease, meaning they were non-responders to the treatment. The researchers used three different methods to predict disease stability. Assays that showed a reduction in Her1/Her1 receptor dimerization, or pairing, coupled with assays that showed an increase in Her1/Her2 receptor dimerization, correlated with stable disease with 100% sensitivity and 88.9% specificity. Assays that showed a reduction in Her1 phosphorylation, or activation, in tumor samples correlated with stable disease with 100% sensitivity and 88.9% specificity. Assays that showed a reduction of Her1 phosphorylation in skin samples predicted stable disease with 85.7% sensitivity and 100% specificity. "We are very encouraged by the results of this pilot study, which reinforce the potential of the eTAG System to provide truly personalized prognostic information. These data mirror results from another recent study utilizing our eTAG technology to predict treatment outcomes in patients with breast cancer," said Sharat Singh, Ph.D., ViroLogic's Chief Technical Officer, Oncology, and co-author of the study. "Our eTAG assays showed excellent correlations with treatment response in both studies. This may be an effective method of predicting outcomes with targeted therapies, and we plan to conduct larger, confirmatory studies." 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 will 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. 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 relating to the ability of the eTag System to predict treatment outcomes, drug potency or selectivity. 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 performance of our products; anticipated progress in development and commercialization of our eTag 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 larger confirmatory clinical studies will confirm the results of initial 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 and reimbursement for our products and adoption of our technological approach and products by pharmaceutical and biotechnology companies; competition from other companies and technologies; our estimate of the size of our markets; our estimates of the levels of demand for our products; our ability to develop sales, marketing and organizational capabilities suitable for the further development and commercialization of our eTag assays; the ultimate validity and enforceability of our patent applications and patents; and the possible infringement of the intellectual property of others. For a discussion of other factors that may cause our actual events to differ from those projected, please refer to our most recent annual report on Form 10-K and quarterly report on Form 10-Q, as well as other subsequent filings with the Securities and Exchange Commission. NOTE: eTag is a trademark of ViroLogic, Inc. Tarceva(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, +1-415-692-4218, or , for ViroLogic Web site: http://www.virologic.com/

Copyright