Pharmacia Presents New Data on Cancer Drugs Showing Promise in Controlling and Shrinking Tumors
- Molecular and Hormonal Options Unveiled at International Symposium -
HAMBURG, Germany, Oct. 13 /PRNewswire/ -- New data on treatments that may
limit the growth of existing tumors and prevent cancer development in
high-risk patients were presented during a symposium held today as part of the
biennial congress of the European Society for Medical Oncology. The latest
data on AROMASIN(R) (exemestane tablets) in breast cancer, SU5416 in
colorectal cancer and the promise of COX-2 specific inhibitors were among the
features.
AROMASIN(R)
AROMASIN, the only oral aromatase inactivator, is being studied for the
first-line, adjuvant (after surgery) and neoadjuvant (before surgery)
treatment of breast cancer. AROMASIN is currently indicated for the treatment
of advanced breast cancer in postmenopausal women whose tumors have stopped
responding to anti-estrogen therapy such as tamoxifen. It is the first in a
new class of oral hormonal inactivator therapies. Aromatase inactivators
permanently bind with the aromatase enzyme, preventing it from producing
estrogen, which some breast cancer tumors need for growth. This contrasts
with aromatase inhibitors that only interfere with the aromatase enzyme in a
reversible manner.
Early results from a Phase II study comparing AROMASIN(R) (exemestane
tablets) with tamoxifen in advanced breast cancer indicate improvements in the
objective response rate, a measurement of how the tumor optimally reacts to
the treatment, (42 percent vs. 16 percent) and average time of tumor growth
and spread (8.9 vs. 5.2 months) in favor of AROMASIN, in 63 evaluable
patients. Additionally, women treated with AROMASIN experienced fewer side
effects (fatigue, pain, hot flashes, sweating and nausea) in comparison to
those treated with tamoxifen. Based on this promising preliminary clinical
data, the European Organization for Research and Treatment of Cancer (EORTC)
expanded this study to a Phase III trial.
"AROMASIN is a promising breast cancer therapy," said Per Eystein L0nning,
M.D., Professor, Department of Medicine, Section of Oncology, Haukeland
University Hospital, Bergen, Norway. "Our work suggests a role for AROMASIN
in many stages of the disease."
Results from a recently completed Phase II neoadjuvant study were also
presented. In this treatment approach, AROMASIN is provided to patients in an
effort to shrink large primary breast cancers prior to surgical removal. This
method of treatment is important for women who are considering breast
conserving surgical options rather than a mastectomy. In a sample of
13 postmenopausal women with estrogen receptor-positive breast cancer,
AROMASIN provided over the course of three months resulted in a median tumor
volume reduction of 83 percent (as assessed by ultrasound).
The efficacy of AROMASIN in the adjuvant treatment for breast cancer is
being examined in worldwide clinical trials involving more than 7,000
patients. In addition, its potential in the prevention of breast cancer is
currently being investigated in other clinical trials.
SU5416
Results from clinical studies of SU5416, an angiogenesis signaling
inhibitor, in the treatment of advanced colorectal cancer were presented.
SU5416 works by inhibiting angiogenesis, the growth of new blood vessels. In
cancer, angiogenesis is the process by which tumors create their own blood
supply to provide nutrients and oxygen essential for their growth.
In a Phase I/II study of 27 evaluable patients treated with SU5416 in
combination with 5-FU/leucovorin, 37 percent of patients had a complete or
partial response to treatment as patients' tumors were reduced by greater than
50 percent of their original size. Forty-four percent of patients had stable
disease, meaning tumors were unchanged having neither grown nor reduced in
size. Only seven percent of patients showed no response to the treatment.
Among this group of patients with previously untreated advanced cancer, tumor
growth and spread was delayed for a median of 9.0 months. Twenty-one of the
27 patients are still alive, so median survival data is unavailable.
"Our studies suggest that SU5416 may make a significant difference for
patients with colorectal cancer," said Lee Rosen, M.D., Assistant Professor,
Director of Cancer Therapy Development Program, UCLA Medical Center. "New
trials are being initiated across Europe that will allow the European oncology
community and patients to participate in the progress of this exciting
therapy."
Trial sites throughout Europe are being enlisted to continue research of
SU5416 in advanced colorectal cancer. SU5416 is also currently being studied
in the US and Germany for the treatment of acute myeloid leukemia. Oral forms
of SU5416 are now being evaluated.
SU5416, a synthetic small molecule inhibitor, is novel because it blocks a
protein called the vascular endothelial growth factor receptor (VEGF-R). By
blocking the VEGF-R, SU5416 could block the ability of tumors to form blood
vessels, thus starving tumors to slow or halt their growth.
COX-2 specific inhibitors
Celebrex(R) (celecoxib capsules) is the first and only pharmacologic agent
approved in the United States to reduce the number of pre-cancerous
(adenomatous) polyps in the treatment of familial adenomatous polyposis (FAP),
as an oral adjunct to usual care (endoscopic surveillance and surgery). FAP
is an inherited condition in which pre-cancerous polyps grow in the colon.
Left untreated, virtually all patients with FAP develop colon cancer by age 40
to 50. Adenomatous polyps are a precursor to more than 95 percent of all
colorectal cancers(1).
Preclinical data presented suggest a possible role for Celebrex in the
potential prevention of several cancers. Celebrex, a COX-2 specific
inhibitor, is currently in worldwide clinical trials to determine whether it
can reduce the occurrence of other forms of pre-cancerous polyps in the colon.
Celebrex is also being investigated across many other pre-malignant
conditions.
Celebrex has been available in the United States since January 1999, where
it is the number-one prescribed osteoarthritis and adult rheumatoid arthritis
medication. Already available in Germany, the United Kingdom, Italy and
Spain, it is now being launched throughout Europe. Celebrex is co-promoted by
Pharmacia Corporation and Pfizer Inc.
Celebrex has not been shown to reduce the risk of gastrointestinal (GI)
cancer or the need for any FAP-related surgeries; therefore, usual endoscopic
surveillance and surgery schedules should not be altered.
The symposium, entitled "Bringing Discovery to Life: Innovative Agents in
Development for the Treatment and Prevention of Cancer," was sponsored by
Pharmacia Oncology in collaboration with the University Clinic of Lubeck in
Lubeck Germany.
Pharmacia Oncology is bringing discovery to life for every person touched
by cancer.
The current oncology portfolio includes AROMASIN(R) (exemestane tablets);
FARMORUBICIN(R)/ELLENCE(TM) (epirubicin hydrochloride injection); CAMPTOSAR(R)
(irinotecan hydrochloride injection); IDAMYCIN(R) (idarubicin hydrochloride
injection); and ZINECARD(R) (dexrazoxane injection). Products in development
include signaling inhibitors SU5416 and SU6668 and other compounds for the
treatment of patients with cancer occurring in various forms.
Pharmacia Corporation is a leading global pharmaceutical company created
through the merger of Pharmacia & Upjohn and Monsanto Company with its
G.D. Searle & Co. unit. Pharmacia (NYSE: PHA) has a broad product portfolio,
a robust pipeline of new drugs, and an annual investment of more than
$2 billion in pharmaceutical research and development.
Pfizer Inc (NYSE: PFE) discovers, develops, manufactures and markets
leading prescription medicines, for humans and animals, and many of the
world's best known over-the-counter brands. This year, Pfizer expects global
sales of more than $31 billion and has a research and development budget of
$4.7 billion.
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concerning the Company's anticipated financial results, current and new
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on factors that involve risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking statements.
Such factors include, among others: management's ability to implement the
strategic initiatives; the Company's ability to successfully market new and
existing products in new and existing domestic and international markets; the
success of the Company's research and development activities and the speed
with which regulatory authorizations and product roll-outs may be achieved;
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Company's exposure to product liability and other lawsuits and contingencies
related to actual or alleged environmental contamination; domestic and foreign
social, legal and political developments, especially those relating to health
care reform and product liabilities; general economic and business conditions;
the Company's ability to attract and retain current management and other
employees of the Company; and other risks and factors detailed in the
Company's Securities and Exchange Commission filings, including its Proxy
Statement and Form 10-K for the year ended December 31, 1999.
(1)Fearon, ER, Vogelstein B. A genetic model for colorectal
tumorigenesis. Cell 61: 759-767, 1990.
SOURCE Pharmacia Corporation
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