Studies Highlight Superior Performance of Trofile(TM) Assay
September 19 2007 - 7:00AM
PR Newswire (US)
Data based on the Trofile assay presented at 47th Annual
Interscience Conference on Antimicrobial Agents and Chemotherapy
SOUTH SAN FRANCISCO, Calif., Sept. 19 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (NASDAQ:MGRM) today announced multiple
presentations demonstrating the strength of its Trofile(TM) Assay
at the 47th Annual Interscience Conference on Antimicrobial Agents
and Chemotherapy (ICAAC). Among the presentations is one that
details the superior ability of Monogram's Trofile assay to
identify HIV patients that are most likely to respond to co-
receptor inhibitors, a new class of drugs, compared to less
sophisticated genotypic approaches. Another presentation reports on
technical advances will allow improvements to be made to the assay
resulting in a tenfold increase in Trofile's ability to identify
patients with virus populations that harbor rare variants that are
unlikely to be inhibited by specific drugs in this new class, and
consequently are prone to treatment failure. Trofile is a
cell-based infectivity assay that directly and accurately
determines whether HIV is able to gain entry into cells via the
CCR5 or CXCR4 co-receptor, or both CCR5 and CXCR4. Last month,
Pfizer Inc. (NYSE:PFE) received FDA approval for Selzentry(TM)
(maraviroc), a CCR5 antagonist and the first orally available HIV
treatment in this new class of medications. In a first for an HIV
drug approval, the FDA approved label states that tropism testing
should be used to guide the use of Selzentry, i.e. identify
patients most likely to respond to treatment. "As the only
clinically proven assay for assessing tropism, our Trofile Assay
has played a critical role in guiding the selection of appropriate
patients for Selzentry in Pfizer's clinical trials and expanded
access program, and that role is expanding now that drug is
approved," said Monogram CEO Bill Young. "The studies presented
this week enhance that position by providing further evidence of
the superiority of our current Trofile Assay over potential
genotypic approaches. Our presentations also detail technological
advances that will improve the ability of the assay by tenfold to
detect whether individuals are infected with CXCR4-tropic viruses,
and therefore unlikely to respond to treatment with
CCR5-inhibitors. In a world where patients and physicians are
increasingly concerned about delivering the right drug to the right
patient at the right time, we are pleased that Monogram continues
to set the highest scientific standards in patient selection."
Trofile More Accurate than V3 Sequencing In a study described in
Abstract #H-1028, Monogram scientists compared the abilities of
nucleic acid sequencing to Monogram's Trofile co-receptor tropism
assay in accurately determining the tropism profile of HIV in
treatment- experienced patients. Conventional nucleic acid
sequencing approaches examine the genetic sequence of a relatively
small region (V3) of the HIV envelope gene and use various
algorithms to derive predictions of coreceptor tropism. Trofile's
phenotypic approach provides a direct determination of co-receptor
tropism by assessing the ability of viruses containing the entire
envelope protein of a patient's virus to infect cells expressing
either the CXCR4 or CCR5 co-receptor. The researchers found that
determining the V3 sequences of envelope genes derived from patient
viruses is technically hampered by the sequence diversity and
heterogeneous length of the V3 region. The study also demonstrated
that when V3 sequences can be unambiguously determined, state of
the art interpretation algorithms significantly under-report the
presence of viruses that use CXCR4 and are therefore highly
unlikely to respond to Selzentry. Results of the study will be
presented at ICAAC on Tuesday, September 18, from 12:15 p.m. to
1:15 p.m. in Hall D. Advancements in Trofile Assay Increase
Sensitivity A second study presented described in Abstract #H-1026
demonstrated that technical enhancements made to the Trofile assay
allow it to identify patients that are infected with viruses that
contain minor subpopulations of CXCR4- using HIV. These advances
should make the Trofile assay an even more powerful tool for the
selection of patients that can be successfully treated with CCR5
inhibitors. The detection of minor variants that use CXCR4 was
enhanced tenfold without sacrificing the ability to reliably detect
CCR5 variants. Results from this study will be presented at ICAAC
on Tuesday, September 18, from 12:15 p.m. to 1:15 p.m. in Hall D.
Tropism and Disease Progression In a third study described in
Abstract #H-1027, Monogram scientists evaluated the correlation
between disease progression and HIV co-receptor tropism in
untreated patients with chronic HIV infection. The study revealed
that among these patients, individuals with viruses that can use
the CXCR4 coreceptor have a faster rate of HIV disease progression
compared to individuals with viruses that use only the CCR5
coreceptor. Results of this study will be presented at ICAAC on
Tuesday, September 18, from 12:15 p.m. to 1:15 p.m. in Hall D.
About Trofile Trofile is a patient selection co-receptor tropism
assay that determines whether a patient is infected with a strain
of HIV that uses either the CCR5 coreceptor, the CXCR4 coreceptor,
or a combination of CCR5 and CXCR4 to enter cells. The use of CCR5,
CXCR4 or both coreceptors defines the "tropism" of the virus
strain. Trofile amplifies the envelope gene from a patient's HIV
genome (from their blood sample) and then uses it to make HIV
particles containing the patient's virus envelope protein. The
resultant HIV particles are then used to infect cells that contain
the CCR5 co-receptor or the CXCR4 co-receptor on the cell surface.
Once the virus infects the cell and it undergoes a single round of
replication. Virus replication results in the production of
luciferase from a luciferase gene that is carried into the cell by
the virus. The production of luciferase in either CCR5 cells, CXCR4
cells or both cell types defines the co-receptor tropism of the
patient virus. 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 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/
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