Pfizer reports long-term safety and efficacy data for HIV drug
Selzentry(TM) (Maraviroc)
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
alone,
-- 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.
About Trofile
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
amerriweather@ jeremiah.hall@
monogrambio.com fkhealth.com
SOURCE Monogram Biosciences, Inc.
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Related links:
http://www.monogrambio.com
CONTACT:
Alfred G. Merriweather, Chief Financial
Officer, Monogram Biosciences, Inc., +1-650-624-4576,
amerriweather@monogrambio.com; Jeremiah Hall, Feinstein Kean
Healthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com
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