Pfizer's Maraviroc, Novel Medicine For HIV, Significantly Reduces Viral Load, in Combination Therapy Across Range of Treatment-E
02 March 2007 - 7:00AM
PR Newswire (US)
Pivotal Data Presented at the 14th Conference on Retroviruses and
Opportunistic Infections (CROI) LOS ANGELES, March 1
/PRNewswire-FirstCall/ -- At this week's major HIV/AIDS research
meeting, Pfizer presented pivotal data of its experimental
medicine, maraviroc, which tackles HIV in an entirely new way. 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. The new data, presented at the 14th Conference on
Retroviruses and Opportunistic Infections (CROI), support the
accelerated United States and European regulatory review of
maraviroc as a treatment for patients infected with HIV that is
"CCR5 tropic," -- enters immune cells by a receptor known as CCR5.
A test confirms whether a patient is infected with CCR5-tropic HIV.
In addition, 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. "Data from the two identical studies are remarkably
consistent and demonstrate significant decreases in viral load and
increases in CD4 cells when maraviroc is added to the standard
optimized treatment regimen," said Dr. Howard Mayer, Pfizer's
global clinical lead for the maraviroc development program, who
also presented the trial results. If approved, maraviroc would be
the first new oral class of HIV medicines in more than a decade,
meeting the urgent need of HIV patients for new drug classes.
Discovered by Pfizer scientists in 1997, maraviroc is an oral
medicine that blocks viral entry to human cells. Rather than
fighting HIV inside white blood cells, it prevents the virus from
entering uninfected cells by blocking its predominant entry route,
the CCR5 co-receptor. Recently, regulatory authorities in the U.S.,
Europe and Canada granted accelerated review of maraviroc.
Accelerated reviews are granted to potential medicines that if
approved have the potential to fulfill an unmet medical need.
Pfizer is also in the process of submitting marketing applications
around the world to make maraviroc available globally. The U.S.
Food and Drug Administration's Antiviral Drugs Advisory Committee
will discuss maraviroc in April. Pfizer is committed to bringing
meaningful improvement to the lives of people living with HIV/AIDS
and those at risk around the world. This commitment is embodied in
Pfizer's products, partnerships, pipeline and philanthropy. Current
initiatives include the U.S. Southern States HIV/AIDS Prevention
Initiative; the building of the Infectious Disease Institute in
Kampala, Uganda; the Pfizer Global Health Fellows Program; and the
Diflucan(R) Partnership Program. For more information on these and
other Pfizer initiatives, go to http://www.pfizer.com/. Background
on data supporting maraviroc The latest results were analyzed at 24
weeks from the ongoing multicenter, double-blind,
placebo-controlled phase 2b/3 MOTIVATE trials (Maraviroc Plus
Optimized Therapy in Viremic Antiretroviral Treatment Experienced
Patients). In both studies, approximately twice as many patients
treated with maraviroc plus optimized background therapy (OBT) for
either once or twice daily dosing achieved undetectable viral loads
(