PhenoSense(R) Integrase Now Enables Clinicians to Monitor Activity of New
Class of Potent Antiretroviral Drugs
SOUTH SAN FRANCISCO, Calif., Aug. 4 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) today announced the launch of its PhenoSense(R) Integrase assay, built on Monogram's proprietary technology platform, PhenoSense(R). The assay directly measures the susceptibility of HIV to a new and potent class of integrase inhibitor drugs that blocks viral replication by preventing viral genes from integrating into the DNA of newly infected cells. Together with PhenoSense GT(R), PhenoSense Integrase provides the most complete picture of resistance to antiretroviral therapies.
PhenoSense Integrase along with other Monogram assays were used to support the clinical trials of the first commercially-available integrase inhibitor, Merck's Isentress(TM) (raltegravir), which received U.S. Food and Drug Administration (FDA) approval in October 2007. In Merck's phase III BENCHMRK trials, Monogram's PhenoSenseGT was used to select optimized drug regimens in the placebo and Isentress-containing treatment arms while PhenoSense Integrase was used to identify and characterize Isentress resistant viruses in treatment failures. The company is also actively involved in the clinical evaluation of Gilead's integrase inhibitor candidate, elvitegravir, currently in Phase III studies. In addition to drug resistance, PhenoSense Integrase also measures reductions in viral replication capacity associated with integrase inhibitor resistance that may help characterize viral fitness.
"Using new antiretroviral drugs correctly today, including HIV integrase inhibitors, is critically important since the pipeline for additional new agents is not likely to provide treatment options beyond our current choices for a number of years," said Dr. Charles Hicks, Associate Professor of Medicine at Duke University Medical Center. "Tools like HIV resistance phenotype tests (including Monogram's PhenoSense Integrase and PhenoSense GT assays) and the HIV tropism assay (Trofile(TM)) are important tools to help clinicians make good choices. They can also help with modifying regimens that are not suppressive by determining whether additional resistance has emerged and which drugs are no longer active."
"As the first and only commercially available assay to measure integrase inhibitor resistance, PhenoSense Integrase exemplifies Monogram's leadership position in personalized medicine and the Company's continued commitment to develop innovative HIV diagnostics that tailor drug treatments to the individual patient," said Monogram CEO William Young. "As evidenced by today's product launch and last year's introduction of Trofile, Monogram is firmly committed to ensuring that cutting-edge diagnostics are readily available to meet the needs of patients and physicians."
The performance of the PhenoSense Integrase assay is validated in compliance with regulations specified by the Clinical Laboratories Improvement Amendments (CLIA) and is performed in Monogram's Clinical Reference Laboratory, which is accredited by the College of American Pathologists (CAP).
About PhenoSense Integrase Assay
PhenoSense Integrase determines the susceptibility of a patient's HIV-1 strain to integrase inhibitors. The region of the HIV genome that encodes integrase is amplified from a patient blood sample and inserted into a proprietary test vector that is used to generate virus particles that replicate using the patient virus integrase protein. Completion of a single replication cycle results in the production of luciferase activity in infected cells. Infection in the presence of drug is performed to determine whether a patient virus is sensitive or resistant to integrase inhibitors. Based on the amount of luciferase activity produced in the absence of drug, PhenoSense Integrase also provides a measure of replication capacity (RC) of integrase inhibitor sensitive and resistant viruses.
Monogram 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.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to the use of our resistance assays, including PhenoSense Integrase, and our Trofile Assay, the size and timing of clinical trials utilizing our products. 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 physicians may not use a molecular diagnostic for patient selection or monitoring for Isentriss, Selzentry or other HIV drugs; risks and uncertainties relating to the performance of our products; the growth in revenues; the size, timing and success or failure of any clinical trials for CCR5 inhibitors, entry inhibitors or integrase inhibitors; 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 impact of competition; the timing and ultimate size of pharmaceutical company clinical trials; whether payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services, including Trofile; whether the draft guidance on Multivariate Index Assays issued by FDA will be subsequently determined to apply to our current or planned products; whether we will encounter problems or delays in automating our processes; the ultimate validity and enforceability of our patent applications and patents; the possible infringement of the intellectual property of others; whether licenses to third party technology will be available; whether we are able to build brand loyalty and expand revenues; restrictions on the conduct of our business imposed by the Pfizer, Merrill Lynch and other debt agreements; the impact of additional dilution if our convertible debt is converted to equity; and whether we will be able to raise sufficient capital in the future, if required. For a discussion of other factors that may cause actual events to differ from those projected, please refer to our 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.
PhenoSense and PhenoSense GT are registered trademarks and Trofile is a
trademark of Monogram Biosciences, Inc. Isentress is a trademark of Merck &
Co., Inc. and Selzentry is a trademark of Pfizer Inc.
Alfred G. Merriweather
Chief Financial Officer
Tel: 650 624-4576
Feinstein Kean Healthcare
Tel: 415 677-2700
|SOURCE Monogram Biosciences, Inc.|
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