Pfizer reports long-term safety and efficacy data for HIV drug
SOUTH SAN FRANCISCO, Calif., Sept. 18 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (Nasdaq: MGRM) announced today that its collaborator Pfizer, Inc. (NYSE: PFE) has separately announced data that reinforces long-term safety and efficacy of Pfizer's oral CCR5-antagonist, Selzentry (Maraviroc), which was recently approved by the FDA and is now available throughout the U.S. Monogram's co-receptor tropism assay, Trofile(TM), was used for patient selection for Selzentry's clinical development program, and is currently being marketed by Monogram's 50-strong sales and marketing organization. Recently, Monogram announced that the contractor that administers Medicare programs in California has established coding procedures for the company's Trofile Assay, indicating Medicare coverage of Trofile throughout the U.S.
At the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting in Chicago, Pfizer presented data from a planned 48-week analysis of its clinical studies of Selzentry in treatment-experienced patients. This analysis confirms the previous 24-week data on which the FDA approval of Selzentry was based. The 48-week analysis showed:
-- that nearly three times as many patients receiving Selzentry in
addition to an optimized background regimen achieved undetectable
levels of virus compared with those receiving an optimized regimen
-- that Selzentry along with an optimized background regimen significantly
increased CD4 cells as compared to patients receiving optimized
background regimen alone, and
-- that patients receiving Selzentry experienced similar adverse events to
those receiving an optimized regimen alone.
Monogram's phenotypic resistance tests were used to optimize background therapy in Selzentry's clinical trials.
Selzentry is designed to work differently from other available HIV medications. CCR5 antagonists block the virus from gaining access into healthy cells via the CCR5 co-receptor, a common pathway for viral entry. Monogram's Trofile co-receptor tropism assay identifies whether individual strains of HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co- receptors to infect healthy cells. This helps clinicians determine whether a CCR5 antagonist like maraviroc may be a good therapeutic option for treating individual patients. Currently available in the U.S., Selzentry is the first drug in a new oral class of HIV medications to be approved in more than ten years. Selzentry (Maraviroc) is under review with European regulatory authorities and recently received a positive opinion from the CHMP.
Selzentry and other entry inhibitors currently in development come at a time when increasing drug resistance makes treating HIV more difficult than ever. Highly sensitive and precise diagnostic tools, such as Trofile, are playing an ever more important role in the development of new therapeutic approaches that give new hope to physicians and patients running low on options.
Trofile is a patient selection co-receptor tropism assay that determines which co-receptor a patient's HIV strain or strains use for viral entry- CCR5, CXCR4, or a combination of CCR5 and CXCR4. Which of these "cellular gateways" that a particular HIV strain uses to gain entry into a healthy CD4+ cell is known as the patients "tropism." Trofile amplifies a patient's HIV genome (from their blood sample) to make HIV particles specific to that individual patient. The resultant HIV particles are then used to infect CCR5- and CXCR4- expressing cell lines. Once the virus infects the cell and undergoes its single round of replication, a reporter gene expresses its indicator gene (luciferase), giving a visible signal-thus identifying the patient's viral tropism. Viral load must be at least 1000 copies/mL to determine a patient's viral tropism.
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 http://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
|SOURCE Monogram Biosciences, Inc.|
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