01.04.2008 21:48:00
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Pfizer Announces Discontinuation of Phase III Clinical Trial for Patients with Advanced Melanoma
Pfizer Inc announced today the discontinuation of a Phase III clinical
trial (A3671009), of single-agent tremelimumab (CP-675,206) in patients
with advanced melanoma, after the review of interim data showed that the
trial would not demonstrate superiority to standard chemotherapy.
Pfizer has communicated with worldwide regulatory authorities and
investigators regarding the discontinuation of the trial. Investigators
will work with their patients to determine if they are benefiting from
treatment and therefore should continue treatment with tremelimumab. All
patients are encouraged to contact their physician with questions about
their treatment.
"Although this outcome is disappointing,
Pfizer remains committed to investigating new treatment options for
patients with melanoma, a high risk area of research with significant
unmet medical need. We continue to focus on additional studies involving
tremelimumab alone and in combination with other therapies which are
currently ongoing in patients with several types of cancer,”
said Charles Baum, M.D., Ph.D., Vice President and Oncology Therapeutic
Area Head at Pfizer Global Research and Development. "We
will continue to assess the study data to understand the clinical
benefit seen in some patients who received tremelimumab.”
The full data set from study A3671009 is being analyzed, and more
details are expected to be available at the upcoming American Society
for Clinical Oncology Annual Meeting in June 2008.
"We have a robust pipeline within Pfizer
Oncology and we remain committed to the discovery and development of
novel cancer treatments which hold promise for patients with cancer,”
said Dr. Baum. "We are extremely grateful for
the strong support we have received for this clinical trial from the
physicians, study staff, and most importantly from the patients.”
Pfizer is developing several classes of agents in its Immuno-Oncology
pipeline including CD40 agonists, toll-like receptor (TLR) agonists and
vaccines.
DISCLOSURE NOTICE: The information contained in this release is as of
April 1, 2008. 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 about an
investigational compound, including its potential benefits, that
involves substantial risks and uncertainties. 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 drug applications that may be filed for
such compound 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, 2007 and in its reports on Form 10-Q and
Form 8-K.
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