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New Data Evaluating SUTENT, CP-751,871 and Axitinib in Patients with Non-Small Cell Lung Cancer.


Pfizer Research Presented at ASCO ASCO American Society of Clinical Oncology
ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland)
ASCO Australian Standard Classification of Occupations
ASCO Automatic Switch Company
 Focuses on Different Approaches to Cancer Treatment

CHICAGO -- Pfizer said today that clinical trials examining its different cancer-fighting approaches showed activity in patients with non-small cell lung cancer Lung Cancer, Non-Small Cell Definition

Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors.
Description

There are two kinds of lung cancers, primary and secondary.
 (NSCLC NSCLC non (or cancer).
NSCLC Non-small cell lung cancer, see there
). Data on SUTENT([R]) (sunitinib malate), as well as the investigational compounds CP-751,871 and axitinib (AG-013736), were presented at the 43rd American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas.  (ASCO) Annual Meeting.

"Pfizer is committed to developing innovative treatments for people with non-small cell lung cancer, the leading cause of cancer death in the United States," said Charles Baum, MD PhD, head of oncology development at Pfizer. "We are encouraged by the positive data presented today, which support our multi-faceted approach to targeting cancer cells."

Sunitinib malate Data

New data were presented from a phase II study demonstrating the anti-tumor activity of sunitinib malate, a multi-kinase inhibitor with anti-angiogenic and anti-proliferative activity. The study examined the safety and efficacy of single-agent sunitinib malate (37.5 mg/day given on a continuous dosing schedule), in 47 previously treated patients with advanced, recurrent NSCLC, who had received one to two prior chemotherapy regimens. The objective response rate was 2.1 percent. 17 percent of patients had stable disease, and observed median overall survival was 37.1 weeks. The study also showed median progression-free survival of 12.3 weeks, and demonstrated a tolerable safety profile. Most common adverse events included fatigue, dyspnea and diarrhea.

These findings further support the rationale for evaluating the role of sunitinib malate in advanced NSCLC in a phase III program which Pfizer plans to initiate later this year.

CP-751,871 Data

Also presented was an interim analysis of an ongoing, phase II, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, non-comparative, multi-center study of CP-751,871. This study evaluated 73 patients with late-stage NSCLC. 46 percent of patients treated with CP-751,871 combined with standard care (paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia);  and carboplatin) achieved an objective response -- meaning the tumor either partially or completely disappeared. In a subset of patients with non-adenocarcinoma (a form of NSCLC), 52 percent of those receiving the combination of CP-751,871, paclitaxel and carboplatin had objective responses. Approximately one-third (32 percent) of patients receiving paclitaxel and carboplatin alone had objective responses. CP-751,871 was well tolerated as a single agent and in combination with paclitaxel and carboplatin; the most common adverse events were hyperglycemia hyperglycemia: see diabetes. , fatigue, neutropenia, and neuropathy. CP-751,871 is part of a treatment approach known as signal transduction, which blocks specific cellular signals important to cancer cell growth and survival. CP-751,871 targets and inhibits signaling on the IGF-1R pathway.

"Non-small cell lung cancer is a complex cancer with limited treatment options," said Daniel Karp, MD, Professor of Thoracic/Head & Neck Medical Oncology at the University of Texas, MD Anderson Cancer Center. "It is very exciting to be working with this new class of compounds targeted at what appear to be a critical pathway in the development of lung cancer. The data presented at ASCO on CP-751,871 support further research in an effort to expand the range of therapies available to physicians, allowing them to better tailor their treatment approach to each individual patient."

Axitinib Data

Promising results were also seen with axitinib, an oral and selective inhibitor of VEGFR VEGFR Vascular Endothelial Growth Factor Receptor  1, 2, 3 (vascular endothelial growth factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature).  receptors 1, 2, 3). An open-label, multi-center phase II study evaluated the efficacy and safety of axitinib in 32 patients with advanced NSCLC, 78 percent of whom had received prior chemotherapy. Axitinib demonstrated activity as a single agent with an objective response rate of 9 percent and median overall survival of approximately 15 months. Axitinib was also well-tolerated in this population. The most common adverse events were fatigue, anorexia, diarrhea and hypertension. Axitinib is part of the therapeutic approach known as anti-angiogenesis, which means it works by inhibiting blood vessel formation, thereby starving tumors of blood and nutrients needed for growth.

PF-3512 676

The company is also developing PF-3512 676, a novel immunotherapeutic based on Toll-Like Receptor 9 agonism. Of the agents Pfizer is investigating for NSCLC, this is in the most advanced stage of development. Data is not being presented at ASCO but accrual of two phase III clinical trials was recently completed.

PF-676

PF-676 is a toll-like receptor (TLR TLR Trailer
TLR Toll Like Receptor (immunological research)
TLR Temple (University) Law Review
TLR Twin Lens Reflex
TLR Texas Law Review
TLR The Last Resort (gaming clan) 
) 9 agonist, which stimulates dendritic cells to trigger a cytokine and chemokine chemokine /che·mo·kine/ (ke´mo-kin) any of a group of low molecular weight cytokines identified on the basis of their ability to induce chemotaxis or chemokinesis in leukocytes (or in particular populations of leukocytes) in inflammation.  cascade and subsequent T-cell activation. Two phase III clinical trials of PF-676, one with paclitaxel plus carboplatin, the other with gemcitibine plus cisplatin, began recruiting patients in November 2005 and completed accrual in April 2007. These studies are international, multi-center, open-label, two-arm, randomized phase III trials. The total enrollment for each study is approximately 800 patients.

About SUTENT([R]) (sunitinib malate)

SUTENT is a multi-kinase inhibitor approved for the treatment of advanced renal cell carcinoma renal cell carcinoma
 or hypernephroma

Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced.
 (RCC RCC - An extensible language. ) and gastrointestinal stromal tumor gastrointestinal stromal tumor GIST Surgical pathology A nonmucosal GI tumor most common in the stomach Clinical Benign–leiomyoma or malignant–leiomyosarcoma, determined histologically by ↑ mitotic activity and bizarre cells, findings seen in  (GIST) after disease progression on or intolerance to imatinib mesylate.

Women of child bearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on SUTENT.

Decreases in left ventricular ejection fraction (LVEF LVEF Left ventricular ejection fraction. See Ejection fraction. ) to below the lower limit of normal (LLN LLN Louvain-La-Neuve (Belgium)
LLN Lifelong Learning Network
LLN Law of Large Numbers
LLN Lower Limit of Normal
LLN Line Link Network
LLN Laboratoire Louis Néel (laboratory at Universite Joseph Fourier Grenoble) 
) have been observed. Patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. .

Patients should be monitored for hypertension and treated as needed with standard antihypertensive antihypertensive /an·ti·hy·per·ten·sive/ (-ten´siv) counteracting high blood pressure, or an agent that does this.

an·ti·hy·per·ten·sive
adj.
Reducing high blood pressure.

n.
 therapy. CBCs with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.

In an ongoing clinical trial of patients with metastatic non-small cell lung cancer (NSCLC), fatal pulmonary hemorrhage occurred in two patients, both with squamous cell histology. SUTENT is not approved for use in patients with NSCLC.

The most common adverse reactions are fatigue, asthenia asthenia /as·the·nia/ (as-the´ne-ah) lack or loss of strength and energy; weakness.

neurocirculatory asthenia
, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspensia, abdominal pain, constipation, hypertension, rash, hand-foot syndrome, skin discoloration, altered taste, anorexia and bleeding.

For more information on SUTENT and Pfizer Oncology please visit www.pfizer.com.

DISCLOSURE NOTICE: The information contained in this release is as of June 2, 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 about various products in development, including their 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 any such products in development as well as their decisions regarding labeling and other matters that could affect their 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.
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Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Jun 2, 2007
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