PhenoSense GT(TM) and PhenoSense Integrase(TM) assays used to study
promising new Integrase inhibitor
SOUTH SAN FRANCISCO, Calif., June 18 /PRNewswire-FirstCall/ -- Monogram
Biosciences, Inc., (Nasdaq: MGRM) announced today that the Company has
signed an agreement with Gilead Sciences, Inc. to provide resistance
testing and consultative services for Gilead's Elvitegravir Phase III
studies. Monogram assays will be used to screen patients for study
enrollment and help select drugs to be given in conjunction with
Elvitegravir during the study. Both Monogram's Integrase phenotype and
genotype assays were used in Elvitegravir preclinical and Phase II studies,
and will be used to evaluate Phase III patient outcomes. The Phase III
studies are anticipated to begin enrolling patients later this year.
Elvitegravir is the most recent Gilead drug to enter Phase III and is
the latest drug in the promising new class of drugs known as "Integrase
inhibitors." Integrase is a viral enzyme that helps HIV integrate its
genetic material into a healthy cell's DNA, allowing that cell to begin
producing genetic material for new viruses. Integrase inhibitors block the
action of this enzyme, interrupting the HIV life cycle before it can begin
reproducing.
"Momentum in new ways to combat HIV, such as Integrase inhibitors, is
vital to dealing with a virus that is becoming increasingly difficult to
treat," said Bill Young, Monogram's chief executive officer. "The
Elvitegravir development program shows the importance of strong
collaborations between diagnostic and drug makers to more quickly get
powerful new treatments into the hands of those who need them most."
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.
About Monogram's Assays
As recommended by the U.S. FDA Antiviral Drugs Advisory Committee,
biopharmaceutical companies use HIV resistance testing technology to
support and enhance next-generation HIV drug development. Monogram's
proprietary technology is being applied to new HIV drug targets for
screening and in subsequent clinical development programs for optimization
of background therapy, patient monitoring and, in the case of CCR5
antagonists, for patient selection. Monogram is a leader in providing drug
susceptibility and tropism assays for pharmaceutical development.
PhenoSense GT(TM) is the only assay combining actual phenotype and genotype
drug results in a single report. PhenoSense GT also includes a measure of
replication capacity (RC), sometimes called viral fitness, and HIV-1
subtype. PhenoSense Entry(TM) is the only commercially available phenotypic
test for measuring susceptibility to entry inhibitors. Similarly,
PhenoSense Integrase(TM), which is a phenotypic test for measuring
susceptibility to integrase inhibitors, is expected to be introduced
commercially soon. Trofile(TM) is a patient selection co-receptor tropism
assay that determines whether a patient is infected with a strain of HIV
that uses the CCR5 co-receptor, the CXCR4 co-receptor, or a combination of
CCR5 and CXCR4 to enter cells. 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. Together these assays
provide the most complete picture of susceptibility to antiretroviral
medications. These assays are used by physicians as an aide to guiding
therapy selection decisions. They are also frequently used by
pharmaceutical companies in phase II and phase III clinical trials for
optimization of background therapy.
Forward Looking Statements
Certain statements in this press release are forward-looking. These
forward-looking statements include references to the demand for our
resistance and tropism assays, the size and timing of clinical trials
utilizing our products and the use of our assays by physicians in guiding
patient therapy decisions. 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; the risk that physicians may not use our resistance tests to
monitor patients being treated with an integrase inhibitor; 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 integrase inhibitors; 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.
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 for Monogram Biosciences, Inc., +1-415-677-2700,
jeremiah.hall@fkhealth.com
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