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additional resistance has emerged and which drugs are no longer active."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
amerriweather@monogrambio.com
Jeremiah Hall
Feinstein Kean Healthcare
Tel: 415 677-2700
jeremiah.hall@fkhealth.com
SOURCE Monogram Biosciences, Inc.
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Related links:
http://www.monogrambio.com
CONTACT:
Alfred G. Merriweather, Chief Financial
Officer, +1-650-624-4576, amerriweather@monogrambio.com; or
Jeremiah Hall, Feinstein Kean Healthcare, +1-415-677-2700,
jeremiah.hall@fkhealth.com
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