SOUTH SAN FRANCISCO, Calif., June 16 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) today announced that data related to the enhanced performance of the company's HIV tropism assay were presented in an oral presentation at the 17th International HIV Drug Resistance Workshop in Sitges, Spain. Trofile was introduced commercially upon FDA approval of Selzentry(TM) (maraviroc), Pfizer's first in class CCR5 antagonist, in August 2007. Recent enhancements to Monogram's Trofile(TM) HIV co-receptor tropism assay have made it substantially more sensitive at identifying minor subpopulations of CXCR4-using virus (X4 or dual/mixed (D/M) tropic) that may portend treatment failure with CCR5 antagonists. The Trofile assay is now capable of detecting CXCR4 tropic virus existing at levels as low as, or in some cases lower than, 0.3% of the total virus population. At levels of X4 using virus as low as 0.3%, Trofile is 100% sensitive.
"The CCR5 antagonist class of drugs has become an important addition to the choice of therapies for treatment of HIV," said Eric Daar, M.D., Chief of HIV Medicine at Harbor-UCLA Medical Center. "Selecting the right patients is critical, not just for the appropriate use of CCR5 antagonists but also to protect the other drugs in the patient's regimen from unnecessary exposure to the development of resistance. The availability of Trofile with enhanced sensitivity now provides further confidence for physicians that treatment choices can be properly assessed."
In an oral presentation during the session on "New Resistance Technologies and Interpretations," Monogram scientist Dr. Jacqueline Reeves presented an analysis of subjects from the AIDS Clinical Trials Group 5211 (ACTG 5211) study. ACTG 5211 was a phase II study of Schering Plough's CCR5 antagonist, vicriviroc, in highly treatment experienced HIV patients. This new analysis compared treatment outcomes based on the prospective selection of patients with R5 tropic virus by the original Trofile test versus treatment outcomes based on the re-classification using the enhanced version of the assay.
The ACTG 5211 study enrolled subjects who had R5 virus at screening as determined by the original Trofile assay. The analysis reported at this week's workshop demonstrated that recent enhancements to Trofile enable the assay to further optimize patient selection for CCR5 antagonist treatment by successfully identifying patients that experienced reduced virologic response to vicriviroc. In the patients originally identified as R5 tropic, based on test results obtained with the newly enhanced sensitivity of Trofile, greater reductions in viral load were observed in vicriviroc recipients confirmed to have pure R5 virus populations (1.95 log reduction at week 24) compared to those newly re-classified as having minor subpopulations of CXCR4-using virus (0.57 log reduction at week 24) (P<0.001).
Additional work described at the meeting focused on the use of Monogram's phenotypic and genotypic technology to identify specific markers of HIV resistance to new drug targets/classes. Monogram has assays in advanced development that accurately assess resistance to CCR5 antagonists such as maraviroc (Selzentry, Pfizer) and vicriviroc (Schering-Plough), and integrase inhibitors such as raltegravir (Isentress, Merck) and elvitegravir (Gilead Sciences).
Trofile, incorporating sensitivity enhancements, together with PhenoSense(TM), PhenoSenseGT(TM) and GeneSeq(TM) HIV drug resistance assays constitute Monogram's portfolio of assays for the optimization of antiretroviral therapy for HIV infection. Determining a patient's HIV profile at the molecular and phenotypic level, and the effect of therapy on that profile, is not only an invaluable part of patient selection for clinical trials, it is also critical to the pre-clinical evaluation of new drug candidates and for optimizing the selection of approved treatments for patient management in routine clinical practice.
Trofile is a clinically validated patient selection tropism assay that determines whether a patient is infected with a strain of HIV that uses either the CCR5 co-receptor (R5), the CXCR4 co-receptor (X4), or a combination of CCR5 and CXCR4 (D/M) to enter cells. The use of CCR5, CXCR4 or both co-receptors defines the "tropism" of the virus strain. Trofile amplifies the entire 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, 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. Trofile is the only clinically validated tropism assay and has been used to select patients in all phase II and phase III studies of CCR5 antagonists to date.
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 demand for our Trofile Assay, the potential use of our Trofile Assay for patient selection for Selzentry , or other CCR5 inhibitors, the size and timing of clinical trials utilizing our products, the outlook for Selzentry and our Trofile Assay, expected protection provided by patents and possible regulation of Trofile and our other products by the FDA. 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 for Selzentry or other HIV drugs; 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, entry inhibitors or integrase inhibitors; the risk that our Trofile Assay may not be utilized for patient use with Selzentry and other CCR5 inhibitors; 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 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.
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
|SOURCE Monogram Biosciences, Inc.|
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