SOUTH SAN FRANCISCO, Calif., Oct. 26 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (NASDAQ:MGRM) announced today that
data presented this week demonstrated that in Pfizer Inc's
(NYSE:PFE) phase III trial of Selzentry(TM) (maraviroc) in
treatment naive individuals with CCR5-tropic HIV-1, increased
efficacy was shown as a result of the enrichment of the patient
population by use of the enhanced version of Monogram's
Trofile(TM) Assay.
The data were reported this week at the 48th Annual Interscience
Conference on Antimicrobial Agents and Chemotherapy (ICAAC) /
46th Annual Meeting of the Infectious Diseases Society of America
(IDSA) in Washington DC.
Pfizer's HIV medication Selzentry (maraviroc) is approved for use
in treatment-experienced individuals with R5-tropic HIV-1. In
July 2007 Pfizer reported data from the phase III trial of
Selzentry in treatment naive individuals ("MERIT"), in which
patients had been selected for treatment by Monogram's Trofile
Assay. The reported differences in outcome for individuals
treated with Selzentry did not meet a predefined study endpoint
of non-inferiority to an established first line treatment
regimen. To week 48, 65% of individuals receiving Selzentry had
HIV-1 RNA <50 copies/mL, compared to 69% of those individuals in
the control arm of the trial.
In June 2008 Monogram introduced an enhanced sensitivity version
of the Trofile Assay, with 30-fold greater sensitivity to detect
low-level X4 HIV compared to the original assay. Monogram
reassessed the original samples from the MERIT trial using the
enhanced Trofile assay. These samples had been previously
archived by Monogram and laboratory personnel had no knowledge of
previous testing results or clinical outcomes data from the
trial. The results obtained with the enhanced sensitivity
version of the Trofile Assay were provided to Pfizer who
conducted the clinical analysis in accordance with a prespecified
statistical analysis plan.
Using the enhanced Trofile assay, 15% of MERIT screening samples
previously defined as R5 HIV were reclassified as CXCR4-using
(Dual/Mixed) HIV, and thus would have been unable to participate
in the study. Analyses restricted to individuals with CCR5-tropic
HIV as determined by the enhanced Trofile assay demonstrated an
overall improvement in Selzentry efficacy relative to efavirenz
(the control arm of the trial). In the new retrospective
analysis of the MERIT trial samples, powered by the enhanced
Trofile assay, 68% of individuals achieved HIV-1 RNA <50
copies/mL at week 48 in both the Selzentry and efavirenz arms of
the study.
"The data presented this week demonstrate the value of selecting
the appropriate individuals for Selzentry therapy," said William
Young, Monogram CEO. "With proper patient selection, using
Trofile, a positive response to therapy can be expected, even in
early stage individuals where the standard of care is already
very high. Monogram's commitment to scientific excellence is
clearly reflected in the data presented this week, which provides
increased hope for individuals infected with HIV that new classes
of drug and new drugs, such as Selzentry, may benefit all HIV
infected individuals, not just those individuals with advanced
disease."
"Selzentry already has a proven record as a safe and effective
therapeutic option for treatment-experienced HIV positive
patients," said W. David Hardy, MD, Director, Division of
Infectious Diseases at Cedars-Sinai Medical Center and Associate
Professor of Medicine at the David Geffen School of Medicine at
UCLA. "Improving our ability to select the best therapy for
patients is critical. These new data enhance the confidence that
physicians need when making treatment choices."
Conference Call
Monogram will host a conference call Monday, October 27 at 4:30
p.m. Eastern Time, in which Dr. David Hardy will review the
clinical use of Selzentry and Trofile. This call will be in
conjunction with Monogram's third quarter conference call. Dr.
Hardy is Director, Division of Infectious Diseases at
Cedars-Sinai Medical Center and is Associate Professor of
Medicine at the David Geffen School of Medicine at UCLA. To
participate in the live teleconference please call (877)
604-9672, or (719) 325-4896 for international callers, fifteen
minutes before the conference begins. Live audio of the call will
be simultaneously broadcast over the Internet and will be
available to members of the news media, investors and the general
public. Access to live and archived audio of the conference call
will be available by following the appropriate links at
www.monogrambio.com and clicking on the Investor Relations link.
Following the live broadcast, a replay of the call will also be
available at (888) 203-1112, or (719) 457-0820 for international
callers. The replay passcode is 4461917. The information provided
on the teleconference is only accurate at the time of the
conference call, and Monogram assumes no obligation to provide
updated information except as required by law.
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 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.
In June 2008, optimization of Trofile made it substantially more
sensitive at identifying very low levels of CXCR4 using virus (X4
or dual/mixed tropic) in HIV-1 patient samples while maintaining
a high degree of accuracy. The assay can now detect X4 virus
present at levels less than 0.3% of the total virus population,
and at that level of X4 virus, the assay is 100% sensitive.
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
www.monogrambio.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking,
including statements regarding the performance, demand and
outlook for our products, including our Trofile and our projected
revenues. 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:
risks and uncertainties relating to the performance and
acceptance 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; 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 existing levels of
reimbursement will be reviewed and reduced by third party payers,
including Medicare; whether the draft guidance on Multivariate
Index Assays issued by the 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, G.E. and other debt agreements; potential
Nasdaq proceedings to delist our common stock, our ability to
regain compliance with Nasdaq listing requirements, the impact of
a possible reverse split of the shares of our common stock, 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.
Source: Monogram Biosciences, Inc.
CONTACT: Alfred G. Merriweather, Chief Financial Officer of
Monogram Biosciences, Inc., +1-650-624-4576, amerriweather@fkhealth.com;
Jeremiah Hall, Feinstein Kean Healthcare, +1-415-677-2700,
jeremiah.hall@monogrambio.com
Web Site: http://www.monogrambio.com/