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
SOURCE Monogram Biosciences, Inc.
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Related links:
http://www.monogrambio.com
CONTACT:
Alfred G. Merriweather, Chief Financial
Officer of Monogram Biosciences, Inc., +1-650-624-4576,
amerriweather@monogrambio.com; or Jeremiah Hall of Feinstein Kean
Healthcare, +1-415-677-2700, jeremiah.hall@fkhealth.com
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