Press Release Source: Monogram Biosciences, Inc.
Studies Highlight Superior Performance of Trofile(TM) Assay
Wednesday September 19, 7:00 am ET
Data based on the Trofile assay presented at 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
SOUTH SAN FRANCISCO, Calif., Sept. 19 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM - News) today announced multiple presentations demonstrating the strength of its Trofile(TM) Assay at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Among the presentations is one that details the superior ability of Monogram's Trofile assay to identify HIV patients that are most likely to respond to co- receptor inhibitors, a new class of drugs, compared to less sophisticated genotypic approaches. Another presentation reports on technical advances will allow improvements to be made to the assay resulting in a tenfold increase in Trofile's ability to identify patients with virus populations that harbor rare variants that are unlikely to be inhibited by specific drugs in this new class, and consequently are prone to treatment failure.
Trofile is a cell-based infectivity assay that directly and accurately determines whether HIV is able to gain entry into cells via the CCR5 or CXCR4 co-receptor, or both CCR5 and CXCR4. Last month, Pfizer Inc. (NYSE: PFE - News) received FDA approval for Selzentry(TM) (maraviroc), a CCR5 antagonist and the first orally available HIV treatment in this new class of medications. In a first for an HIV drug approval, the FDA approved label states that tropism testing should be used to guide the use of Selzentry, i.e. identify patients most likely to respond to treatment.
"As the only clinically proven assay for assessing tropism, our Trofile Assay has played a critical role in guiding the selection of appropriate patients for Selzentry in Pfizer's clinical trials and expanded access program, and that role is expanding now that drug is approved," said Monogram CEO Bill Young. "The studies presented this week enhance that position by providing further evidence of the superiority of our current Trofile Assay over potential genotypic approaches. Our presentations also detail technological advances that will improve the ability of the assay by tenfold to detect whether individuals are infected with CXCR4-tropic viruses, and therefore unlikely to respond to treatment with CCR5-inhibitors. In a world where patients and physicians are increasingly concerned about delivering the right drug to the right patient at the right time, we are pleased that Monogram continues to set the highest scientific standards in patient selection."
Trofile More Accurate than V3 Sequencing
In a study described in Abstract #H-1028, Monogram scientists compared the abilities of nucleic acid sequencing to Monogram's Trofile co-receptor tropism assay in accurately determining the tropism profile of HIV in treatment- experienced patients. Conventional nucleic acid sequencing approaches examine the genetic sequence of a relatively small region (V3) of the HIV envelope gene and use various algorithms to derive predictions of coreceptor tropism. Trofile's phenotypic approach provides a direct determination of co-receptor tropism by assessing the ability of viruses containing the entire envelope protein of a patient's virus to infect cells expressing either the CXCR4 or CCR5 co-receptor. The researchers found that determining the V3 sequences of envelope genes derived from patient viruses is technically hampered by the sequence diversity and heterogeneous length of the V3 region. The study also demonstrated that when V3 sequences can be unambiguously determined, state of the art interpretation algorithms significantly under-report the presence of viruses that use CXCR4 and are therefore highly unlikely to respond to Selzentry. Results of the study will be presented at ICAAC on Tuesday, September 18, from 12:15 p.m. to 1:15 p.m. in Hall D.
Advancements in Trofile Assay Increase Sensitivity
A second study presented described in Abstract #H-1026 demonstrated that technical enhancements made to the Trofile assay allow it to identify patients that are infected with viruses that contain minor subpopulations of CXCR4- using HIV. These advances should make the Trofile assay an even more powerful tool for the selection of patients that can be successfully treated with CCR5 inhibitors. The detection of minor variants that use CXCR4 was enhanced tenfold without sacrificing the ability to reliably detect CCR5 variants. Results from this study will be presented at ICAAC on Tuesday, September 18, from 12:15 p.m. to 1:15 p.m. in Hall D.
Tropism and Disease Progression
In a third study described in Abstract #H-1027, Monogram scientists evaluated the correlation between disease progression and HIV co-receptor tropism in untreated patients with chronic HIV infection. The study revealed that among these patients, individuals with viruses that can use the CXCR4 coreceptor have a faster rate of HIV disease progression compared to individuals with viruses that use only the CCR5 coreceptor. Results of this study will be presented at ICAAC on Tuesday, September 18, from 12:15 p.m. to 1:15 p.m. in Hall D.
About Trofile
Trofile is a patient selection co-receptor tropism assay that determines whether a patient is infected with a strain of HIV that uses either the CCR5 coreceptor, the CXCR4 coreceptor, or a combination of CCR5 and CXCR4 to enter cells. The use of CCR5, CXCR4 or both coreceptors defines the "tropism" of the virus strain. Trofile amplifies the envelope gene from a patient's HIV genome (from their blood sample) and then uses it to make HIV particles containing the patient's virus envelope protein. The resultant HIV particles are then used to infect cells that contain the CCR5 co-receptor or the CXCR4 co-receptor on the cell surface. Once the virus infects the cell and it undergoes a single round of replication. Virus replication results in the production of luciferase from a luciferase gene that is carried into the cell by the virus. The production of luciferase in either CCR5 cells, CXCR4 cells or both cell types defines the co-receptor tropism of the patient virus.
About Monogram Biosciences, Inc.
Monogram 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 www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. These forward-looking statements include references to the potential for an HIV drug that requires a molecular diagnostic for patient selection. 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 related to the market acceptance of Selzentry and ongoing and future clinical trials of Selzentry; whether competitive tropism assays are developed and commercialized by others; whether third party payers will provide coverage and reimbursement for the Trofile Assay; risks related to the implementation of the collaboration with Pfizer; 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 or entry inhibitors; the use of our Trofile Assay for patient use with Selzentry; 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; whether payors will authorize reimbursement for our products and services; whether the FDA or any other agency will decide to further regulate our products or services; 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; and whether we will be able to raise sufficient capital in the future, if required. 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 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.
Trofile is a trademark of Monogram Biosciences, Inc. Selzentry is a trademark of Pfizer Inc.
contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624-4576 Tel: 415 677-2700
amerriweather@ jeremiah.hall@
monogrambio.com fkhealth.com
Source: Monogram Biosciences, Inc.
