Monogram Biosciences Launches First Resistance Assay for HIV Integrase Inhibitors
August 04 2008 - 8:30AM
PR Newswire (US)
PhenoSense(R) Integrase Now Enables Clinicians to Monitor Activity
of New Class of Potent Antiretroviral Drugs SOUTH SAN FRANCISCO,
Calif., Aug. 4 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc.
(NASDAQ:MGRM) today announced the launch of its PhenoSense(R)
Integrase assay, built on Monogram's proprietary technology
platform, PhenoSense(R). The assay directly measures the
susceptibility of HIV to a new and potent class of integrase
inhibitor drugs that blocks viral replication by preventing viral
genes from integrating into the DNA of newly infected cells.
Together with PhenoSense GT(R), PhenoSense Integrase provides the
most complete picture of resistance to antiretroviral therapies.
PhenoSense Integrase along with other Monogram assays were used to
support the clinical trials of the first commercially-available
integrase inhibitor, Merck's Isentress(TM) (raltegravir), which
received U.S. Food and Drug Administration (FDA) approval in
October 2007. In Merck's phase III BENCHMRK trials, Monogram's
PhenoSenseGT was used to select optimized drug regimens in the
placebo and Isentress-containing treatment arms while PhenoSense
Integrase was used to identify and characterize Isentress resistant
viruses in treatment failures. The company is also actively
involved in the clinical evaluation of Gilead's integrase inhibitor
candidate, elvitegravir, currently in Phase III studies. In
addition to drug resistance, PhenoSense Integrase also measures
reductions in viral replication capacity associated with integrase
inhibitor resistance that may help characterize viral fitness.
"Using new antiretroviral drugs correctly today, including HIV
integrase inhibitors, is critically important since the pipeline
for additional new agents is not likely to provide treatment
options beyond our current choices for a number of years," said Dr.
Charles Hicks, Associate Professor of Medicine at Duke University
Medical Center. "Tools like HIV resistance phenotype tests
(including Monogram's PhenoSense Integrase and PhenoSense GT
assays) and the HIV tropism assay (Trofile(TM)) are important tools
to help clinicians make good choices. They can also help with
modifying regimens that are not suppressive by determining whether
additional resistance has emerged and which drugs are no longer
active." "As the first and only commercially available assay to
measure integrase inhibitor resistance, PhenoSense Integrase
exemplifies Monogram's leadership position in personalized medicine
and the Company's continued commitment to develop innovative HIV
diagnostics that tailor drug treatments to the individual patient,"
said Monogram CEO William Young. "As evidenced by today's product
launch and last year's introduction of Trofile, Monogram is firmly
committed to ensuring that cutting-edge diagnostics are readily
available to meet the needs of patients and physicians." The
performance of the PhenoSense Integrase assay is validated in
compliance with regulations specified by the Clinical Laboratories
Improvement Amendments (CLIA) and is performed in Monogram's
Clinical Reference Laboratory, which is accredited by the College
of American Pathologists (CAP). About PhenoSense Integrase Assay
PhenoSense Integrase determines the susceptibility of a patient's
HIV-1 strain to integrase inhibitors. The region of the HIV genome
that encodes integrase is amplified from a patient blood sample and
inserted into a proprietary test vector that is used to generate
virus particles that replicate using the patient virus integrase
protein. Completion of a single replication cycle results in the
production of luciferase activity in infected cells. Infection in
the presence of drug is performed to determine whether a patient
virus is sensitive or resistant to integrase inhibitors. Based on
the amount of luciferase activity produced in the absence of drug,
PhenoSense Integrase also provides a measure of replication
capacity (RC) of integrase inhibitor sensitive and resistant
viruses. 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 use of our resistance assays, including
PhenoSense Integrase, and our Trofile Assay, the size and timing of
clinical trials utilizing our products. 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 or monitoring for
Isentriss, Selzentry or other HIV drugs; 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; 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. PhenoSense and PhenoSense GT are registered
trademarks and Trofile is a trademark of Monogram Biosciences, Inc.
Isentress is a trademark of Merck & Co., Inc. and Selzentry is
a trademark of Pfizer Inc. Contacts: Alfred G. Merriweather Chief
Financial Officer Tel: 650 624-4576 Jeremiah Hall Feinstein Kean
Healthcare Tel: 415 677-2700 DATASOURCE: Monogram Biosciences, Inc.
CONTACT: Alfred G. Merriweather, Chief Financial Officer,
+1-650-624-4576, ; or Jeremiah Hall, Feinstein Kean Healthcare,
+1-415-677-2700, Web site: http://www.monogrambio.com/
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