DHHS Guidelines Support Use Of Trofile(TM) Assay Prior To CCR5 Inhibitor Use

Main Category: HIV / AIDS
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 05 Feb 2008 - 0:00 PDT

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Monogram Biosciences, Inc. (Nasdaq: MGRM) announced that guidelines issued by the Department of Health and Human Services (DHHS) recommend that a co-receptor tropism test, such as Monogram's Trofile(TM) assay, should be performed whenever the use of a CCR5 inhibitor is being considered and might also be considered for patients who exhibit virologic failure on a CCR5 inhibitor.

The Panel on Antiretroviral Guidelines for Adult and Adolescents guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents, Department of Health and Human Services, January 29, 2008, were developed by a working group of the Office of AIDS Research Advisory Counsel, the National Institutes of Health advisory body on HIV research and treatment policy and initiatives. These guidelines follow the FDA's instructions on Selzentry's label, which call for tropism testing prior to prescribing the drug. Pfizer's Selzentry(TM) (maraviroc) is the first CCR5 inhibitor to receive FDA approval.

"The Office of AIDS Research recommendations and DHHS guidelines underscore the importance of using a clinically validated tropism test to determine whether a patient should be treated with a CCR5 inhibitor," said Monogram Biosciences CEO William Young. "Our Trofile assay is the only test currently available that can provide accurate, reproducible results to guide treatment with this new class of medications."

Monogram's Trofile(TM) assay was used to select patients for participation in the pivotal clinical trials that formed the basis of approval for Selzentry and is being used in every advanced CCR5 inhibitor development program currently underway. In addition to calling for tropism testing to select patients for CCR5 inhibitor therapy, the new DHHS guidelines acknowledge the potential benefits of testing following CCR5 inhibitor treatment failure, which would determine whether or not the patient's HIV experienced a shift in viral tropism while on the therapy. The DHHS guidelines recommend only high- throughput phenotypic assays be used for co-receptor testing for CCR5 therapeutics at this time and acknowledge that genotypic assays, while under investigation, are currently not commercially available.

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, 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.

About Monogram

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 the class of HIV drugs known as CCR5 antagonists, the size and timing of our customers' clinical trials utilizing our products, the outlook for the CCR5 class of drugs and our Trofile Assay, the number of patients each year in the U.S. who potentially could be candidates for new classes of HIV drugs such as CCR5 antagonists, expected protection provided by patents, 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 CCR5 antagonists or other HIV drugs; whether larger confirmatory clinical studies will confirm the results of initial studies; 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 CCR5 inhibitors; our ability to successfully conduct clinical studies and the results obtained from those 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 and Phenosense GT are trademarks of Monogram Biosciences, Inc.

Monogram Biosciences, Inc.
http://www.monogrambio.com