Company Continues to Lead Tropism Testing Field
SOUTH SAN FRANCISCO, Calif., Feb. 7 /PRNewswire-FirstCall/ -- Monogram
Biosciences, Inc (Nasdaq: MGRM) today announced that data related to the
company's advanced HIV tropism assay have been presented as multiple
posters during the 15th Conference on Retroviruses and Opportunistic
Infections (CROI) this week in Boston, MA. Highlights from the meeting
include data on an enhanced version of the Trofile(TM) Assay's superior
ability to identify patients that are not likely to respond to CCR5
antagonist therapy, as well as data that sheds new light on how patients
develop resistance to this new class of drugs.
During the "Emerging Patterns of Resistance to New Antiretrovirals"
session at CROI, Monogram participated in a number of poster presentations,
including:
-- An Enhanced Version of the Trofile HIV Co-receptor Tropism Assay
Predicts Emergence of CXCR4 Use in ACTG5211 Vicriviroc Trial Samples
-- Emergence in vivo of Vicriviroc Resistance in HIV-1 Subtype C: Role of
V3 Loop and Susceptibility to Other CCR5 Antagonists
-- Changes in V3 Loop Sequence Associated with Failure of Maraviroc
Treatment in Patients Enrolled in the MOTIVATE 1 and 2 Trials
The first presentation analyzed subjects from the AIDS Clinical Trials
Group 5211 study and compared co-receptor tropism results (R5, X4 or
dual/mixed DM HIV) of the original Trofile test with those obtained using
an enhanced version of the assay. Researchers found that the enhanced
Trofile assay would have further optimized patient selection for this new
drug class by successfully identifying patients with low levels of DM (non
R5) HIV at screening and who subsequently experienced treatment failure on
a CCR5 antagonist.
Trofile has been proven to be a critically important tool for ensuring
that CCR5 antagonists are administered safely -- and the only such tool
currently available. This has been reinforced by the issuance by the
Department of Health and Human Services of its updated guidelines for HIV
treatment, in which it recommended that a tropism test should be used prior
to initiation of CCR5 treatment and may also be considered at failure of
therapy. The DHHS guidelines also cited the Trofile assay by Monogram as
the assay "used to screen patients who were participating in studies that
formed the basis of approval for Selzentry, the only CCR5 inhibitor
currently available.
Data from the other presentations show specific markers of HIV
resistance to CCR5 antagonists, particularly the role that mutations in the
V3 loop play. Based on these and other studies, Monogram has been the first
to identify specific changes that have become a standard marker of CCR5
antagonist resistance.
"Monogram tests, particularly our Trofile Assay, have been pivotal to
CCR5 drug development programs," said Monogram CEO William Young. "Trofile
is well established as the only clinically validated tropism assay and as
the data presented this week reaffirms, our enhanced tropism assay, which
we expect to be commercially available soon, sets an even higher standard
of sensitivity for CCR5 positive patients."
Monogram's tests have been used throughout the development of the CCR5
class of drugs. In addition to the use of Trofile for patient selection and
the use of Phenosense for optimization of background therapy in the phase
II and phase III clinical trials of Pfizer's maraviroc (Selzentry(TM)) and
Schering Plough's vicriviroc, Monogram has also recently signed an
agreement with Incyte Corporation to provide resistance and tropism testing
for Incyte's investigational CCR5 antagonist, INCB9471. INCB9471 is
currently in Phase II development. Two six-month Phase IIb clinical trials
are expected to begin in 2008 in which Monogram's Trofile tropism assay
will be used to select and monitor patients, and the PhenoSenseGT(TM) assay
will be used to optimize background therapy for patients enrolled in the
trial.
"INCB9471 has the potential to become an important tool in the fight
against drug-resistance HIV," said Sue Erickson-Viitanen, Incyte's Sr.
Director of Virology Drug Development. "Selecting the appropriate patients
is critical to the success of our clinical development program. We're
confident Monogram's leadership in HIV diagnostics and the Trofile assay's
established position as the only clinically validated tropism test, provide
a solid foundation for successfully progressing INCB9471 forward in these
upcoming trials."
"Incyte's CCR5 antagonist has the potential to be a very significant
addition to HIV therapy, and we are delighted to be working with Incyte on
their program," said Young.
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, 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. Trofile is the only clinically validated
tropism assay and has been used to select patients in all phase II and
phase III studies of CCR5 antagonists to date.
Trofile is a trademark of Monogram Biosciences. Selzentry is a
trademark of Pfizer Inc.
About Monogram
Monogram is a biotechnology company 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 demand for our Trofile
Assay, the potential use of our Trofile Assay for patient selection for the
class of HIV drugs known as CCR5 antagonists, the size and timing of our
customers' clinical trials utilizing our products, the outlook for the CCR5
class of drugs and our Trofile Assay, the number of patients each year in
the U.S. who potentially could be candidates for new classes of HIV drugs
such as CCR5 antagonists, expected protection provided by patents, possible
regulation of Trofile and our other products by the FDA. 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 physicians may not use a molecular diagnostic for patient
selection for CCR5 antagonists or other HIV drugs; whether an enhanced
version of Trofile will be successfully validated, introduced commercially
and adopted by physicians; whether larger confirmatory clinical studies
will confirm the results of initial studies; 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, entry inhibitors or integrase inhibitors; the risk that our
Trofile Assay may not be utilized for patient use with CCR5 inhibitors; our
ability to successfully conduct clinical studies and the results obtained
from those 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 payers will authorize reimbursement for our
products and services and the amount of such reimbursement that may be
allowed; whether the FDA or any other agency will decide to further
regulate our products or services, including Trofile; whether the draft
guidance on Multivariate Index Assays issued by FDA will be subsequently
determined to apply to our current or planned products; 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; restrictions on the conduct of
our business imposed by the Pfizer, Merrill Lynch and other debt
agreements; the impact of additional dilution if our convertible debt is
converted to equity; and whether we will be able to raise sufficient
capital in the future, if required. For a discussion of other factors that
may cause 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.
Contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624 4576 Tel: 415 677 2700
amerriweather@monogrambio.com jeremiah.hall@fkhealth.com
SOURCE Monogram Biosciences, Inc
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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, for
Monogram Biosciences, Inc
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