Pfizer Announces Plans to Establish Expanded Access Program for Maraviroc, Investigational HIV CCR5 Antagonist

New York (ots/PRNewswire) -

- Broad Access Program for Patients with Limited Available
Treatment Options

Pfizer announced today that it plans to establish a multi-national
Expanded Access Program (EAP) to make the investigational CCR5
antagonist maraviroc, currently in ongoing phase 3 clinical trials,
available to HIV/AIDS patients with CCR5-tropic HIV-1 who have
limited or no approved treatment options due to resistance or
intolerance. Pending regulatory review and approvals of the EAP study
protocol, the program will begin enrolling patients in the next few
months, with a target to enroll patients from over 30 countries.

Maraviroc is in a new class of investigational HIV drugs known as
CCR5 antagonists, designed to work differently from currently
available HIV/AIDS antiretroviral medicines. Rather than fighting HIV
inside white blood cells, CCR5 antagonists prevent the virus from
entering cells by blocking its predominant entry route, the CCR5
co-receptor.

The EAP is designed to provide access to maraviroc for patients
who, in the opinion of the program investigators, need it to create a
viable regimen. "People living with HIV whose virus is resistant to
available therapies have an urgent need for novel medicines," said
John LaMattina, president, Pfizer Global Research and Development.
"It is our hope that maraviroc, now in final stages of clinical
development, may help those patients who have exhausted treatment
options and are not already participating in our clinical studies."

Pfizer confirmed plans to submit applications for marketing
approval in both the U.S. and EU following review of the data from
the two Phase 3 maraviroc registrational trials. These are 24-week
studies of Optimized Background Therapy (OBT), with or without
maraviroc, in highly treatment experienced patients with CCR5-tropic
HIV-1. Pfizer will submit these results expeditiously for
presentation at an upcoming HIV conference.

To broaden the program's reach, Pfizer is recruiting many
investigators with previous EAP experience as well as HIV clinical
experts at centers which have not previously engaged in expanded
access initiatives. Study patients will receive open-label maraviroc
twice daily in addition to OBT. In some circumstances, the study
allows the use of OBT that may contain other investigational
antiretroviral agents in Phase 3 clinical development.

Health care professionals interested in enrollment should contact
their local Pfizer office.

Maraviroc Expanded Access Study Design

Investigators will follow patients in the EAP according to their
local standard of care. The study will continue in each country until
marketing approval and reimbursement is obtained in that country and
the patient can obtain drug through local commercial distribution
channels.

Pending regulatory review, preliminary program eligibility
criteria include patients who are, clinically stable with documented
CCR5- tropic HIV-1 infection; at least 16 years of age (or minimum
adult age as determined by local regulatory authorities or as legal
requirements dictate); have limited or no treatment options available
to them due to resistance or treatment intolerance; and they must be
failing to achieve adequate virologic suppression on their current
regimen. The study cannot include patients who have failed prior
treatment with any CCR5 antagonist in a clinical trial; have evidence
of dual/mixed-tropic or X4-tropic HIV; require any medications
prohibited by the EAP protocol; have a condition which the study
investigator deems will interfere with the patient's adherence and
safety; or who are pregnant or lactating. Investigators will select
the OBT based on the patient's prior treatment history and
antiretroviral resistance testing conducted according to local
practice. Pfizer will not provide OBT. Pfizer will monitor safety and
tolerability of maraviroc throughout the course of the study.

Web site: http://www.pfizer.com

ots Originaltext: Pfizer Inc.
Im Internet recherchierbar: http://www.presseportal.de

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