Four Studies Affirm Significance of Monogram's Trofile(TM) HIV Co-Receptor Tropism Assay
2006年8月18日 - 7:00AM
PRニュース・ワイアー (英語)
Data based on the Trofile assay presented at XVI International AIDS
Conference SOUTH SAN FRANCISCO, Calif., Aug. 17
/PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. (NASDAQ:MGRM)
today reported that four studies demonstrating the utility and
clinical significance of its Trofile(TM) co-receptor tropism assay
had been presented at the XVI International AIDS Conference in
Toronto. The studies suggest the need for and value of phenotypic
assays in evaluating co-receptor tropism. Tropism refers to the
specific cellular co-receptors (either CCR5 or CXCR4) that
individual strains of HIV use to gain access to host cells.
Analyzing tropism plays an essential role in determining whether
the use of new drugs which target the CCR5 co-receptor (CCR5
antagonists) is likely to be effective in individual HIV-infected
patients. Monogram's Trofile assay is able to directly and
accurately determine whether a patient's virus is able to gain
entry into cells via the CCR5 or CXCR4 co-receptor, or a
combination of the two. The Trofile assay has been used for patient
selection in Pfizer's phase III trial of maraviroc, its
investigational CCR5 antagonist, and Monogram is collaborating with
Pfizer Inc. to make its co-receptor tropism assay available for
patient use on a global basis in anticipation of FDA and EMEA
approval. "Drug resistance continues to be a major problem in HIV
management, and patients are in need of new classes of drugs,
including CCR5 antagonists," said Monogram CEO Bill Young. "Despite
advances in treatment options for HIV-infected patients, we know
that not every drug candidate is appropriate for every patient. Our
assays help screen patients to identify those most likely to
respond to these new classes of drugs based on the tropism of the
infecting virus." The first study (Abstract #THPE0045), confirms
that the Trofile assay can accurately characterize the tropism of a
panel of diverse HIV strains. Researchers at Monogram used the
assay to evaluate the co-receptor tropism of a panel of 46
well-characterized strains of HIV-1 that included multiple subtypes
(CCR5, CXCR4, or dual/mixed tropism (DM)). The assay accurately
measured the tropism of all 46 strains. The assay also was accurate
when tested against three clonal viruses (CCR5, CXCR4 and DM). When
CCR5 and CXCR4 clones were mixed together, the assay was able to
detect minor variants down to 10 percent in all samples tested, and
to 5 percent in 83 percent of samples tested. To date, 94 percent
of more than 8,000 samples received for ongoing clinical trials of
co-receptor antagonists in North America and Europe have been
successfully tested. Together, the data show that Monogram's
Trofile assay is an accurate, precise, sensitive, reproducible and
robust assay for the measurement of tropism and support its use as
the standard assay for patient screening and monitoring in the
development of co-receptor antagonists. The second study, also
presented by Monogram scientists (Abstract #THPE0046), compared the
abilities of V3 sequencing and Monogram's Trofile assay to
accurately characterize tropism. V3 sequencing examines the genetic
sequence of only the V3 region of the envelope gene of HIV taken
from a patient and uses algorithms to predict co-receptor tropism.
The Trofile assay uses the entire envelope gene taken from the
patient's virus to measure viral tropism directly. The study used
patient-derived virus sequences representing multiple subtypes of
HIV-1, and found that sensitivity for detection of viruses using
the CXCR4 co-receptor varied widely depending on viral sub-type and
on the interpretation system used. In comparison to phenotypic
analysis with Trofile, which accurately and directly measures
co-receptor usage, genotypic measures, on average, were only
approximately 65% accurate, and in many cases were even less
accurate. These results demonstrate that genotypic approaches are
inferior for assessing tropism when compared with Trofile. "These
data confirm that the Trofile assay is more sensitive and precise
in determining co-receptor tropism," said Chris Petropoulos, Chief
Scientific Officer. "The region of the virus involved in cellular
entry has a particularly heterogeneous genetic sequence, which
renders genotypic methods significantly less effective." In a study
(Abstract #THLB0215) presented by scientists from Pfizer, Inc., the
negative predictive value of Monogram's Trofile co-receptor tropism
assay was assessed in an ongoing Phase III trial of Pfizer's
investigational CCR5 antagonist, maraviroc (Study 1029). Results
show that patients identified by the assay as having virus using
both the CXCR4 and CCR5 receptors (dual/mixed tropic) did not
respond to the investigational (CCR5) therapy. These data suggest
that screening patients with the Trofile assay will allow
physicians to avoid treating patients with expensive drug therapy
who are unlikely to respond to that therapy. A separate study
(Abstract #THLB0217) presented by investigators from the AIDS
Clinical Trial Group 5211 study team and Schering Plough
demonstrated the positive predictive value of the assay in patients
participating in a Phase IIb trial of Schering-Plough's
investigational CCR5 antagonist vicriviroc. In this study, patients
identified by the assay as having virus utilizing only the CCR5
co-receptor demonstrated clinical responses to the investigational
therapy. "These data suggest that the Trofile co-receptor tropism
assay is an effective method of identifying appropriate patients
for treatment with CCR5 antagonists," said Petropoulos. "By virtue
of its high positive and negative predictive values, the Trofile
assay is highly capable of insuring that individuals receive
treatments that are most likely to provide them with clinical
benefit." 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: the risk
that regulatory authorities may not require a molecular diagnostic
for patient selection for an HIV drug, 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 Co-Receptor Tropism Assay for patient use in the event of
approval of any CCR5 inhibitors; our ability to successfully
conduct clinical studies and the results obtained from those
studies; 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 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; 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; 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.
CONTACT: 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 for Monogram Biosciences, Inc., +1-415-677-2700, Web
site: http://www.monogrambio.com/
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