Maraviroc Reduces HIV Viral Load in Treatment-Naive Patients, 48 Week Data Show
July 25 2007 - 6:00AM
PR Newswire (US)
Pfizer reports clinical study results SOUTH SAN FRANCISCO, Calif.,
July 25 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc.
(NASDAQ:MGRM) announced today that its collaborator Pfizer Inc
(NYSE:PFE) has reported results of a phase III study of its
investigational HIV medication, maraviroc, for treatment-naive
adult patients infected with CCR5-tropic HIV-1. The data was
reported by Pfizer at the International Aids Society conference in
Sydney, Australia. "Pfizer's results indicate reduction in viral
load and increased CD4 counts," said Christos Petropoulos, Monogram
Chief Scientific Officer. "In addition, the trial showed a safety
profile that was better than in the control arm. This further
supports the safety of maraviroc as a new treatment option for
treatment-experienced patients." Monogram's Trofile(TM) Assay has
been used to select patients for all of the drug's clinical trials.
Pfizer has previously reported 24 week data from its phase III
trials of maraviroc in treatment-experienced patients and has
recently announced that the 48 week analysis has confirmed these 24
week findings. An NDA is pending with the U.S. Food and Drug
Administration and an approvable letter has been received from the
F.D.A. in respect of the use of maraviroc in treatment- experienced
patients. The data reported today by Pfizer is in respect of a
potential new indication in treatment-naive patients that would be
subject to a separate FDA submission. 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 use of our Trofile Assay as a molecular
diagnostic for patient selection for Pfizer's CCR5 antagonist
maraviroc, if approved by the FDA and European authorities, and the
potential approval of maraviroc for use in treatment-na�ve
patients. 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 a molecular diagnostic
for patient selection for maraviroc; the risk that maraviroc will
not be approved by the FDA or European authorities for use in
treatment-experienced patients; the risk that Pfizer will not
submit marketing applications for use of maraviroc in
treatment-na�ve patients and that the FDA will not approve such
marketing applications; risks related to the implementation of the
collaboration with Pfizer; risks associated with establishing and
maintaining logistics arrangements in European and other non-U.S.
markets for Trofile; risks and uncertainties relating to the
performance of our products; the growth in revenues and actual
market acceptance of our products; the impact of competition;
whether payors will authorize reimbursement for our Trofile;
whether the FDA or any other agency will decide to further regulate
Trofile and our other products; 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; and whether
we will be able to raise sufficient capital in the future, if
required. For a discussion of other factors that may cause our
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, +1-415-677-2700, , for
Monogram Biosciences, Inc. Web site: http://www.monogrambio.com/
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