Pfizer Initiates Phase III Trial to Study Sunitinib Malate in Patients with Metastatic Colorectal Cancer



    Pfizer announced today the initiation of a Phase III clinical
    trial to evaluate the safety and efficacy of sunitinib malate, in
    combination with a standard chemotherapy regimen, in patients with
    metastatic colorectal cancer (mCRC) - cancer originating in the colon
    that has spread to other parts of the body. In addition, new data from
    a Phase I study being presented this week at the World Congress on
    Gastrointestinal Cancer (WCGC) in Barcelona showed that sunitinib
    malate is active and generally well-tolerated in combination with a
    standard chemotherapy regimen, FOLFIRI, in previously untreated
    patients with mCRC. These data support further evaluation of sunitinib
    malate in mCRC in a Phase III program.

    "We are encouraged by these data, which add to a growing body of
    research demonstrating the activity and tolerability of sunitinib
    malate in numerous cancers," said Charles Baum, MD PhD, head of
    oncology development at Pfizer. "Based on these early findings
    presented this week, Pfizer is committed to continued exploration of
    sunitinib malate in the treatment of advanced colorectal cancer
    through a global Phase III program."

    Sunitinib Malate Phase III Trial in Colorectal Cancer

    A multi-national Phase III study is currently open and enrolling
    in Europe, Canada, Asia and South America and will include more than
    700 patients to evaluate the safety and efficacy of sunitinib malate
    combined with FOLFIRI, a standard chemotherapy regimen used in mCRC
    comprised of fluorouracil (5-FU), folinic acid (leucovorin), and
    irinotecan, compared with FOLFIRI plus placebo, in the first-line
    treatment of patients with mCRC.

    Sunitinib malate is a multi-kinase inhibitor which works by
    inhibiting angiogenesis, the process by which tumors acquire blood
    vessels bringing oxygen and nutrients needed for growth, and
    proliferation, the process by which cells multiply.

    Phase I Study in Metastatic Colorectal Cancer

    New data presented this week from an ongoing, open-label Phase I
    trial of 16 previously untreated mCRC patients randomized to three
    distinct dosing regimens, determined the maximum tolerated dose (MTD)
    for sunitinib malate of four weeks on treatment followed by two weeks
    off (4/2) in combination with FOLFIRI was 37.5 mg/day. This regimen
    appeared to be active and generally well-tolerated in patients who
    have received no prior treatment for metastatic disease. Of the 10
    patients who received this dosing regimen, four patients experienced
    partial response to date and stable disease has been observed in six
    patients. Treatment emergent grade greater than or equal to 3 adverse
    events for patients on the sunitinib malate 37.5 mg/day 4/2 regimen
    were one case of respiratory tract infection and two cases of
    neutropenia without fever.

    "Despite progress in recent years, colorectal cancer remains a
    hard-to-treat cancer for which new options are sorely needed," said
    Alfredo Carrato MD, PhD, Elche University Hospital and lead
    investigator on the sunitinib malate multi-national Phase III trial in
    mCRC. "These data support further research of sunitinib malate in
    metastatic colorectal cancer, in an effort to potentially expand the
    range of therapies available to physicians and patients."

    For more information about sunitinib malate trials currently open
    and enrolling, please visit www.ClinicalTrials.gov or
    www.suntrials.com or call Pfizer Oncology's toll-free number at
    001-646-277-4066.

    DISCLOSURE NOTICE: The information contained in this release is as
    of June 28, 2007. Pfizer assumes no obligation to update any
    forward-looking statements contained in this release as the result of
    new information or future events or developments.

    This release contains forward-looking information that involves
    substantial risks and uncertainties about a potential additional
    indication for sunitinib malate, including its potential benefits.
    Such risks and uncertainties include, among other things, the
    uncertainties inherent in research and development; decisions by
    regulatory authorities regarding whether and when to approve any
    supplemental drug applications that may be filed for this additional
    indication as well as their decisions regarding labeling and other
    matters that could affect its availability or commercial potential;
    and competitive developments.

    A further description of risks and uncertainties can be found in
    Pfizer's Annual Report on Form 10-K for the fiscal year ended December
    31, 2006 and in its reports on Form 10-Q and Form 8-K.