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
http://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 http://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.
contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624-4576 Tel: 415 677-2700
amerriweather@fkhealth.com jeremiah.hall@monogrambio.com
SOURCE Monogram Biosciences, Inc.
 back to top
Related links:
http://www.monogrambio.com
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
|
