VLGC Virologic (MM)

ViroLogic Awarded $1.5 Million Grant to Fund Large-Scale Clinical Studies Evaluating Replication Capacity as a Predictive Tool for the Clinical Management of HIV SOUTH SAN FRANCISCO, Calif., June 24 /PRNewswire-FirstCall/ -- ViroLogic, Inc. (NASDAQ:VLGC) announced today that the company has been awarded a phase II Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to assess HIV replication capacity (RC), a gauge of viral "fitness," as a predictor of the pace of progression to clinical AIDS. "Numerous clinical studies performed to date strongly suggest a role for RC in the management of HIV-infected patients, particularly in clinical scenarios where physicians currently need better guidance. This grant will allow ViroLogic and academic collaborators to examine the potential clinical utility of RC more thoroughly so that we can better define exactly which patients may benefit from assessments of RC," said Michael Bates, M.D., Vice President of Clinical Research at ViroLogic. "We believe this follow-on Phase II SBIR grant underscores our ability to deliver on our scientific objectives and provides strong validation of our research and assay development expertise." The SBIR grant will make it possible for ViroLogic to evaluate RC in multiple large cohorts that include a variety of patient subtypes and span the breadth of treatment experience from untreated to heavily treated HIV-infected individuals, as well as to gain a better understanding of how to interpret RC values for optimum clinical benefit. This phase II grant is a continuation of a two-year phase I grant originally awarded in July 2001 that was used to successfully develop a rapid, reproducible assay for the assessment of RC. Full laboratory validation has been completed and the assay has achieved CLIA and CAP certification. About Replication Capacity (RC) RC provides a measure of the ability of HIV to replicate and to destroy the immune system. RC testing is only commercially available with ViroLogic's PhenoSense(TM) and PhenoSense GT(TM) assays, and is currently included with those resistance test results free of charge. Genetic changes (mutations) in HIV that confer drug resistance often impair the virus' ability to replicate efficiently and lead to reduced viral RC. Previous clinical studies have found that patients experiencing treatment failure due to drug resistance characterized by increasing viral load with stable CD4 T-cell counts also have virus with a relatively low RC. Other data suggest that RC is not simply a surrogate for drug resistance, but rather is an inherent characteristic of HIV that impacts the pathogenicity of different viral isolates. Taken together, these data suggest potential roles for RC in the management of HIV-infected patients in both treatment-na�ve and treatment-experienced situations. About ViroLogic ViroLogic is a biotechnology company advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious viral diseases such as AIDS and hepatitis. The Company's products are designed to help doctors optimize treatment regimens that lead to better patient outcomes and reduced costs. ViroLogic's technology is also being used by numerous biopharmaceutical companies to develop new and improved anti-viral therapeutics and vaccines targeted at emerging drug-resistant viruses. More information about the Company and its technology can be found on its web site at http://www.virologic.com/. Certain statements in this press release are forward-looking, including statements regarding activities expected to occur in connection with the SBIR grant discussed in this press release and the potential role for RC in the management of HIV-infected patients. 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, the risk that the Company may not utilize the full amounts authorized under the grant in the manner discussed in this press release, the risk that the programs funded by this grant may not achieve desired results, whether ViroLogic successfully introduces new products, whether others introduce competitive products, the risk that the Company's products for patient testing may not continue to be accepted or that increased demand from drug development partners may not develop as anticipated, the risk that gross margins may not increase as expected, the risk that ViroLogic may not continue to realize anticipated benefits from its cost-cutting measures, the timing of pharmaceutical company clinical trials, whether payors will authorize reimbursement for its products, whether the FDA or any other agency will decide to regulate ViroLogic's products or services, whether the Company will encounter problems or delays in automating its processes, whether intellectual property underlying the Company's PhenoSense technology is adequate, whether licenses to third party technology will be available, whether ViroLogic is able to build brand loyalty and expand revenues, 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. DATASOURCE: ViroLogic, Inc. CONTACT: Karen Wilson, CFO of ViroLogic, Inc., +1-650-624-4164, or Web site: http://www.virologic.com/

Copyright