Monogram
Biosciences Launches New "Trofile" HIV Co-receptor Tropism Test to Select Patients
Eligible to User CCR5 Antagonist Maraviroc (Selzentry)
On
August 6, 2007, South San Francisco-based Monogram Biosciences announced the launch
of its latest HIV diagnostic test, the "Trofile" co-receptor tropism
assay.
In order
to enter human cells, HIV must attach to the CD4 cell surface receptor plus one
of two co-receptors, CCR5 or CXCR4. Different strains of HIV use different co-receptors,
and some can use both.
CCR5
antagonists, such as Pfizer's recently approved maraviroc
(Selzentry), prevent HIV from entering cells using the CCR5 co-receptor. The
drug only works against virus that uses this co-receptor, not CXCR4.
The
Trofile test determines which co-receptor a person's HIV uses, and thus whether
maraviroc and similar drugs are likely to work for that individual. Trofile was
used for patient selection for maraviroc clinical trials, and Pfizer and Monogram
are collaborating to make the test available for use worldwide.
Below
is an excerpt from Monogram's press release announcing the launch of the new assay:
Monogram
Announces Commercial Introduction of Trofile Assay
Advanced
diagnostic supports appropriate use of Pfizer's newly FDA-approved CCR5 antagonist,
Selzentry (maraviroc) tablets
SOUTH SAN FRANCISCO, Calif.,
Aug 06, 2007 -- PRNewswire-FirstCall via COMTEX News Network -- Monogram Biosciences,
Inc. (Nasdaq: MGRM) today announced the launch of the company's latest HIV diagnostic,
the Trofile co-receptor tropism assay.
This launch follows the announcement
that Pfizer Inc (NYSE: PFE) has received FDA approval today of novel HIV therapy,
Selzentry (maraviroc) tablets. Trofile was the pivotal test used for patient selection
for Selzentry's clinical development program and the two companies are engaged
in a collaboration agreement to make Monogram's assay available for patient use
globally.
"Trofile is a vital new tool that helps physicians make
the most informed treatment decisions for their patients living with HIV. Combined
with Pfizer's new therapy, this represents a major milestone in the treatment
of HIV," said Monogram CEO Bill Young. "Today's approval also marks
an important landmark in personalized medicine as the healthcare community shifts
to treat patients individually by combining powerful diagnostic tools with drug
therapies to better predict an individual patient's response."
Selzentry
has been approved for the combination antiretroviral treatment of adults infected
with only CCR5-tropic HIV-1 who have evidence of viral replication and have HIV-1
strains resistant to multiple antiretroviral agents. In a first for an HIV drug
approval, the FDA approved label requires that tropism testing to identify patients
infected with R5 virus guide the use of Selzentry. Trofile is the only clinically
proven diagnostic that can be used to determine viral tropism.
"The
availability of Selzentry and Trofile come at a time when increasing drug resistance
makes treating HIV more complex than ever," said Douglas Richman, MD, Professor
of Pathology and Medicine at the University of California, San Diego School of
Medicine, and the Director of the Research Center for AIDS and HIV Infection at
the San Diego VA Medical Center. "Monogram's Trofile Assay is a highly sensitive
and precise diagnostic that will play a critically important role in bringing
a new therapeutic approach to physicians and patients running low on options.
Trofile, like Monogram's resistance tests, will become an integral part of the
treatment landscape for HIV patients."
Trofile Assays have been performed
on more than 23,000 samples in the company's CLIA-certified laboratory. Trofile
results are summarized in an easy-to-understand report indicating the patient's
HIV tropism and are delivered to physicians in approximately 14 days. "We
have already introduced the Trofile Assay and its clinical value to physicians
in Selzentry's expanded access program (EAP) and to many of the larger public
and private payers," said William Welch, Monogram's chief commercial officer.
"Our initial feedback from payers indicates that, like physicians, they will
appreciate the benefits of Trofile in identifying HIV patients who are most likely
to respond to CCR5 therapy."
Monogram has provided its assays to
HIV clinicians for several years through a well established commercial infrastructure
throughout the United States. Monogram will continue working with HIV physicians,
patients and patient advocates, public and private payers, to provide broad access
and to establish specific payer coverage and reimbursement for Trofile in the
U.S. market. Monogram is making Trofile available to physicians immediately, so
that it can be used to select patients in advance of Pfizer making Selzentry available
in pharmacies.
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 www.monogrambio.com.
08/14/07
Source Monogram
Biosciences. Monogram Announces Commercial Introduction of Trofile Assay. Press
release. August 6, 2007.
