Monogram Provides Update on Trofile(TM) Assay - Pfizer Reports Significant Reduction in Viral Load in Clinical Trial of Maraviro
March 01 2007 - 3:06PM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif., March 1 /PRNewswire-FirstCall/ --
Monogram Biosciences, Inc. (NASDAQ:MGRM) announced today that its
collaborator Pfizer, Inc. (NYSE:PFE) has separately announced
results from phase III clinical trials of maraviroc. Monogram's
co-receptor tropism assay, Trofile(TM), was used for patient
selection for maraviroc's clinical development program, and the two
companies are engaged in a collaboration agreement to make
Monogram's assay available for patient use on a global basis.
Pfizer presented pivotal data of its experimental medicine,
maraviroc, which tackles HIV in an entirely new way. Pfizer
reported that this data indicated a significant reduction in viral
load. A 24 week analysis showed that approximately twice as many
patients receiving maraviroc with an optimized background regimen
achieved undetectable virus in the blood than if an optimized
regimen was given alone. Pfizer also noted that the new data,
presented at the 14th Conference on Retroviruses and Opportunistic
Infections (CROI), supports the previously announced accelerated
U.S. and European regulatory review of maraviroc as a treatment for
patients infected with HIV that is "CCR5 tropic." In addition,
Pfizer reported that patients receiving maraviroc and an optimized
regimen saw an increase in CD4 cells nearly twice that seen in
those receiving optimized regimen alone. Adverse events in the
group receiving maraviroc plus an optimized regimen were similar to
those receiving an optimized regimen alone when adjusted for
duration of exposure. Maraviroc is designed to work differently
from other available HIV medications. CCR5 antagonists block the
virus from gaining access into healthy cells via the CCR5
co-receptor, a common pathway for viral entry. Monogram's Trofile
co-receptor tropism assay identifies whether individual strains of
HIV use the CCR5 co-receptor, the CXCR4 co-receptor or both co-
receptors to infect healthy cells. This helps clinicians determine
whether a CCR5 antagonist like maraviroc may be a good therapeutic
option for treating individual patients. Maraviroc is currently
under accelerated review with U.S., Canadian and European
regulatory authorities, and if approved, would be the first new
oral class of HIV medicines in more than a decade. Maraviroc and
other entry inhibitors currently in development come at a time when
increasing drug resistance makes treating HIV more difficult than
ever. Highly sensitive and precise diagnostic tools are playing an
ever more important role in the development of new therapeutic
approaches that give new hope to physicians and patients with few
remaining options. 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. These forward-looking statements include
references to the potential for an HIV drug that requires a
molecular diagnostic for patient selection, expected protection
provided by patents, and activities expected to occur in connection
with the Pfizer collaboration. 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 regulatory authorities may not require or
recommend a molecular diagnostic for patient selection for an HIV
drug, risks related to the implementation of the collaboration with
Pfizer; risks related to our ability to recognize revenue from
activities under 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 use of our Trofile co-receptor tropism assay for
patient use in the event of approval of any CCR5 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; whether payors will authorize
reimbursement for our products and services; whether the FDA or any
other agency will decide to further regulate our products or
services, whether the draft guidance on Multivariate Index Assays
recently issued by FDA applies 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 and Merrill Lynch debt agreements;
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 DATASOURCE: Monogram
Biosciences, Inc. CONTACT: Alfred G. Merriweather, Chief Financial
Officer of Monogram Biosciences, Inc., +1-650-624-4576, or , or
Jeremiah Hall of Feinstein Kean Healthcare, +1-415-677-2700, or ,
for Monogram Biosciences, Inc. Web site:
http://www.monogrambio.com/
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