Monogram Biosciences Collaborates with Gilead Sciences for Elvitegravir Phase III Studies
June 18 2008 - 6:00AM
PR Newswire (US)
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
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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