SOUTH SAN FRANCISCO, Calif., May 24 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. announced today that it has received Notices of Allowance from the United States Patent Office for key patent applications related to the use of Monogram's phenotypic technology for assessing the efficacy of entry inhibitors, a new class of drug that prevents HIV from entering cells. In addition to the measurement of resistance of HIV to entry inhibitors, the patented technology enables the identification of co-receptor usage by HIV -- i.e. whether the CCR5 or CXCR4 co-receptor is used by a patient's virus, and accordingly whether CCR5 inhibitors may be appropriate treatments for individual patients.
"These patent allowances add to the basic patents covering our phenotypic approach, and enhance our proprietary position related to the Co-Receptor Tropism Assay and Entry Assay," said William D. Young, Monogram chief executive officer. "We believe that these molecular diagnostic tests may have an important role in patient screening and monitoring for the new class of HIV drugs that target viral entry to cells. In particular our Co-Receptor Tropism assay has been used for patient selection in Phase III trials of CCR5 inhibitors and may have a similar role in clinical use of these drugs, if the drugs are approved by regulatory authorities."
Of the approximately 500,000 patients in care for HIV/AIDS in the U.S., there are about 150,000 patients who have already experienced multiple treatment failures, and for whom a new class of drug, such as CCR5 inhibitors, may be a highly beneficial treatment option. Each year, approximately 65,000 of these patients fail therapy. Monogram's Co-Receptor Tropism Assay can be used to screen these patients to identify whether a CCR5 inhibitor may be an appropriate treatment option.
The phenotypic approach covered by these patents is able to directly and accurately assess the susceptibility or resistance of a patient's HIV to entry inhibitors, and to determine to what extent a patient's virus is able to gain entry into cells via one or other, or a mixture, of the two major co-receptors, CCR5 or CXCR4. The patents cover technology that will allow Monogram to:
* assess how resistant a patient's virus is to entry inhibitors, * identify the "tropism" that a patient's virus exhibits (i.e. whether it uses the CCR5 or CXCR4 co-receptor, or both), * screen for new entry inhibitor compounds, and * test for antibody responses capable of blocking infection, a critical need in assessing HIV vaccines.
This technology provides the most reliable way to assess the effectiveness of HIV entry inhibitors and to identify co-receptor utilization by HIV. Monogram's assays utilizing this technology include the PhenoSense(TM) Entry Assay that assesses resistance of HIV to all classes of entry inhibitor drugs and the Co-Receptor Tropism Assay that identifies the ability of a patient's HIV to enter cells using specific co-receptors such as CCR5.
"These allowed patents, covering our phenotypic approach, are important because the envelope region of the virus (the area involved in cell entry) has a particularly heterogeneous genetic sequence," said Christos Petropoulos, Monogram chief scientific officer." This renders genotypic methods significantly less effective for measuring co-receptor tropism and resistance to specific viral entry inhibitors, giving Monogram's phenotypic methods significant advantages."
About Monogram
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 http://www.monogrambio.com .
Forward Looking Statements
Certain statements in this press release and attached supplemental information are forward-looking. These forward-looking statements include references to potential commercial opportunities provided by the current HIV drug development pipeline, the potential use for the Company's tests in early access programs as well as in commercial use of CCR5 entry inhibitor drugs if approved by the FDA, the expected timing of certain CCR5 clinical trials and the advantages of phenotypic testing over genotypic testing. 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 performance of our products; the size, timing and success or failure of any clinical trials for CCR5 inhibitors, entry inhibitors or integrase inhibitors; the use of our Co-receptor Tropism assay for patient use in the event of approval of any 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; whether phenotypic analysis will be perceived by the medical community as superior to genotypic analysis; 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 and physicians; 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 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; 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. 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.
PhenoSense is a trademark of Monogram Biosciences, Inc. contacts: Alfred G. Merriweather Jeremiah Hall Chief Financial Officer Feinstein Kean Healthcare Tel: 650 624 4576 Tel: 415 677-2700 amerriweather@monogrambio.comjeremiah.hall@fkhealth.com
Monogram Biosciences, Inc.CONTACT: Alfred G. Merriweather, Chief Financial Officer of MonogramBiosciences, Inc., +1-650-624-4576, amerriweather@monogrambio.com; orJeremiah Hall of Feinstein Kean Healthcare, +1-415-677-2700,jeremiah.hall@fkhealth.com, for Monogram Biosciences, Inc.
Web site: http://www.monogrambio.com/
