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PRNewswire - December 15, 2005
SOUTH SAN FRANCISCO, Calif., Dec. 15 /PRNewswire-FirstCall/ -- Monogram BioSciences, Inc. (Nasdaq: MGRM) today announced the presentation of five abstracts related to its portfolio of HIV resistance assays at the 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Data in one abstract demonstrate that the combination of HIV phenotype and genotype testing (PTGT) using PhenoSense GT(TM) is cost-effective compared with genotyping (GT) alone. Studies validating Monogram's PhenoSense(TM) HIV Entry susceptibility assay and highlighting the importance of HIV co-receptor tropism in progression to AIDS also were presented. Additional abstracts discussed data related to the company's PhenoSense and GeneSeq assays.
Cost-effectiveness data were presented by Eoin Coakley, M.D. Monogram Medical Director, in a poster titled "Cost Effectiveness Analysis of Combined Phenotype and Genotype Drug Resistance Testing Versus Genotyping Alone" (Abstract H-1054/269). This study was designed to determine the cost per quality adjusted life year (QALY) and incremental cost-effectiveness of PTGT compared with GT. Results show that, for treatment-experienced patients, PTGT was more cost-effective than GT alone.
"Chronic management of HIV infection is a complex endeavor that must address a variety of factors, including viral resistance profiles, patient preferences and healthcare economics," said Andrew R. Zolopa, Professor of Medicine at Stanford University, a co-author of the study. "The use of combination genotypic and phenotypic information to create successful treatment regimens is advancing the management of HIV infection. These data show that in treatment-experienced patients, the use of a comprehensive set of phenotypic and genotypic data improves healthcare economics and patient care and is an essential component of antiretroviral therapy."
Data related to Monogram's PhenoSense Entry susceptibility assay and the company's co-receptor tropism assay also were presented. PhenoSense Entry is the only commercially available phenotypic susceptibility assay for entry inhibitors, a new class of HIV therapies that inhibit the virus' ability to enter cells. The assay is used to support development of entry inhibitors and to guide treatment of HIV-infected individuals. Abstract H1076/291 describes the validation and performance characteristics of PhenoSense Entry and concludes that the assay is an important new tool for the development of novel fusion inhibitors and the selection and monitoring of antiretroviral treatment regimens.
Abstract H-1890/293 described a case report of a patient who experienced rapid progression to AIDS after infection with a multi-drug resistant, dual- tropic strain of HIV. Longitudinal analysis with Monogram's Co-Receptor Tropism assay over two years revealed evolution of viral tropism from a more pathogenic virus utilizing the CXCR4 co-receptor to a less pathogenic strain utilizing the CCR5 co-receptor. The report underscores the importance of viral tropism studies in understanding how HIV tropism impacts progression to AIDS.
Additional abstracts presented are:
* "Assessing the Continuum of Antiretroviral Drug Susceptibility: The Derivation of Drug Susceptibility Cutoffs for the PhenoSense Assay Based on Clinical Correlations" H-1055/270
* "Unexplained Protease Inhibitor (PI) Resistance in Clinical Isolates Lacking Known Primary PI Mutations" H-1062/277
"Monogram is committed to leading the development of innovative and superior assays for improving the treatment of HIV," said William Young, Monogram chief executive officer. "PhenoSense GT provides comprehensive information critical to guiding the selection of optimal therapeutic treatment regimens for patients and we have demonstrated that this approach has superior cost-effectiveness compared with genotyping alone. We continue to drive the field of HIV testing forward, as evidenced by PhenoSense Entry and the Co-Receptor Tropism assay."
Monogram believes that its HIV tests have been used in the clinical trials of every drug approved for the treatment of HIV in the past five years. The company has active collaborations with almost all of the major pharmaceutical companies that are developing HIV drugs. "Our assays are enabling the pharmaceutical industry to innovate new HIV treatments more effectively, which should help speed new therapies to market," said Young.
About Monogram Biosciences, Inc.
Monogram, formerly ViroLogic, Inc., is 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.monogrambio.com.
PhenoSense is a trademark of Monogram Biosciences, Inc.
FORWARD LOOKING STATEMENTS
Certain statements in this press release are forward-looking, including statements regarding the role of Monogram's tests in the development and use of drugs for treatment of HIV. 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 size, timing and success or failure of any CCR5 clinical trials; the use of our Co-receptor Tropism assay for patient use in the event of approval of any CCR5 inhibitors; 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; our ability to establish reliable, high-volume operations at commercially reasonable costs; expected reliance on a few customers for the majority of our revenues; the annual renewal of certain customer agreements; 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; the timing and ultimate size of pharmaceutical company clinical trials; whether payors will authorize reimbursement for its products; whether the FDA or any other agency will decide to regulate Monogram's products or services; whether the Company will encounter problems or delays in automating its processes; whether licenses to third party technology will be available; whether Monogram is able to build brand loyalty and expand revenues; and whether Monogram will be able to raise sufficient capital when required. For a discussion of other factors that may cause Monogram'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.
contacts:
Alfred G. Merriweather - Chief Financial Officer
Tel: 650 624 4576 -- amerriweather@monogrambio.com
Jeremiah Hall - Feinstein Kean Healthcare
Tel: 415 677-2700 -- jeremiah.hall@fkhealth.com
SOURCE Monogram BioSciences, Inc.
Web Site: http://www.monogrambio.com
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