Monogram Announces Commercial Introduction of Trofile(TM) Assay
August 06 2007 - 2:05PM
PR Newswire (US)
Advanced diagnostic supports appropriate use of Pfizer's newly
FDA-approved CCR5 antagonist, Selzentry(TM)(maraviroc) tablets
SOUTH SAN FRANCISCO, Calif., Aug. 6 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (NASDAQ:MGRM) today announced the launch
of the company's latest HIV diagnostic, the Trofile(TM) co-receptor
tropism assay. This launch follows the announcement that Pfizer Inc
(NYSE:PFE) has received FDA approval today of novel HIV therapy,
Selzentry(TM) (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, M.D., 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. Conference Call Details Monogram
will host a conference call to discuss plans for commercial
introduction of Trofile in the U.S. The call will take place on
Tuesday, August 7 and details of the call will be announced as soon
as possible. 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 DATASOURCE: Monogram Biosciences, Inc. CONTACT: Alfred
G. Merriweather, Chief Financial Officer of Monogram Biosciences,
Inc., +1-650 624-4576, ; or Jeremiah Hall of Feinstein Kean
Healthcare, +1-415 677-2700, Web site: http://www.monogrambio.com/
Copyright
Monogram Technologies (NASDAQ:MGRM)
Historical Stock Chart
From Jun 2024 to Jul 2024
Monogram Technologies (NASDAQ:MGRM)
Historical Stock Chart
From Jul 2023 to Jul 2024