SOUTH SAN FRANCISCO, Calif., June 16 /PRNewswire-FirstCall/ -- Monogram
Biosciences, Inc. (Nasdaq: MGRM) today announced that data related to the
enhanced performance of the company's HIV tropism assay were presented in
an oral presentation at the 17th International HIV Drug Resistance Workshop
in Sitges, Spain. Trofile was introduced commercially upon FDA approval of
Selzentry(TM) (maraviroc), Pfizer's first in class CCR5 antagonist, in
August 2007. Recent enhancements to Monogram's Trofile(TM) HIV co-receptor
tropism assay have made it substantially more sensitive at identifying
minor subpopulations of CXCR4-using virus (X4 or dual/mixed (D/M) tropic)
that may portend treatment failure with CCR5 antagonists. The Trofile assay
is now capable of detecting CXCR4 tropic virus existing at levels as low
as, or in some cases lower than, 0.3% of the total virus population. At
levels of X4 using virus as low as 0.3%, Trofile is 100% sensitive.
"The CCR5 antagonist class of drugs has become an important addition to
the choice of therapies for treatment of HIV," said Eric Daar, M.D., Chief
of HIV Medicine at Harbor-UCLA Medical Center. "Selecting the right
patients is critical, not just for the appropriate use of CCR5 antagonists
but also to protect the other drugs in the patient's regimen from
unnecessary exposure to the development of resistance. The availability of
Trofile with enhanced sensitivity now provides further confidence for
physicians that treatment choices can be properly assessed."
In an oral presentation during the session on "New Resistance
Technologies and Interpretations," Monogram scientist Dr. Jacqueline Reeves
presented an analysis of subjects from the AIDS Clinical Trials Group 5211
(ACTG 5211) study. ACTG 5211 was a phase II study of Schering Plough's CCR5
antagonist, vicriviroc, in highly treatment experienced HIV patients. This
new analysis compared treatment outcomes based on the prospective selection
of patients with R5 tropic virus by the original Trofile test versus
treatment outcomes based on the re-classification using the enhanced
version of the assay.
The ACTG 5211 study enrolled subjects who had R5 virus at screening as
determined by the original Trofile assay. The analysis reported at this
week's workshop demonstrated that recent enhancements to Trofile enable the
assay to further optimize patient selection for CCR5 antagonist treatment
by successfully identifying patients that experienced reduced virologic
response to vicriviroc. In the patients originally identified as R5 tropic,
based on test results obtained with the newly enhanced sensitivity of
Trofile, greater reductions in viral load were observed in vicriviroc
recipients confirmed to have pure R5 virus populations (1.95 log reduction
at week 24) compared to those newly re-classified as having minor
subpopulations of CXCR4-using virus (0.57 log reduction at week 24)
(P<0.001).
Additional work described at the meeting focused on the use of
Monogram's phenotypic and genotypic technology to identify specific markers
of HIV resistance to new drug targets/classes. Monogram has assays in
advanced development that accurately assess resistance to CCR5 antagonists
such as maraviroc (Selzentry, Pfizer) and vicriviroc (Schering-Plough), and
integrase inhibitors such as raltegravir (Isentress, Merck) and
elvitegravir (Gilead Sciences).
Trofile, incorporating sensitivity enhancements, together with
PhenoSense(TM), PhenoSenseGT(TM) and GeneSeq(TM) HIV drug resistance assays
constitute Monogram's portfolio of assays for the optimization of
antiretroviral therapy for HIV infection. Determining a patient's HIV
profile at the molecular and phenotypic level, and the effect of therapy on
that profile, is not only an invaluable part of patient selection for
clinical trials, it is also critical to the pre-clinical evaluation of new
drug candidates and for optimizing the selection of approved treatments for
patient management in routine clinical practice.
About Trofile
Trofile is a clinically validated patient selection tropism assay that
determines whether a patient is infected with a strain of HIV that uses
either the CCR5 co-receptor (R5), the CXCR4 co-receptor (X4), or a
combination of CCR5 and CXCR4 (D/M) to enter cells. The use of CCR5, CXCR4
or both co-receptors defines the "tropism" of the virus strain. Trofile
amplifies the entire 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.
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
Selzentry , or other CCR5 inhibitors, the size and timing of clinical
trials utilizing our products, the outlook for Selzentry and our Trofile
Assay, expected protection provided by patents and 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 Selzentry or other
HIV drugs; 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, entry inhibitors or integrase
inhibitors; the risk that our Trofile Assay may not be utilized for patient
use with Selzentry and other 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 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.
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@monogrambio.com jeremiah.hall@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 for Monogram Biosciences, Inc., +1-415-677-2700,
jeremiah.hall@fkhealth.com
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