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Preliminary Results Show Potential of Novel Angiogenesis Signaling Inhibitor SU5416 to Inhibit Growth and
Spread of Colorectal Cancer
Encouraging One Year Tolerability Data Presented
In Patients with Colorectal Cancer
NEW ORLEANS, May 23 /PRNewswire/ -- Preliminary results for the novel
angiogenesis signaling inhibitor, SU5416, show that when the drug is given to
patients with untreated, advanced (known as metastatic) colorectal cancer, it
may extend the time patients remain free of tumor growth and spread.
Phase I/II data presented today at the annual meeting of the American Society
of Clinical Oncology also suggest that SU5416 is well tolerated for at least
one year when combined with 5-fluorouracil/leucovorin (5-FU/LV). SU5416 was
developed by Sugen, a wholly owned subsidiary of Pharmacia Corporation.
Angiogenesis signaling inhibitors, drugs being developed to starve tumors of
their blood supply and thus inhibit their growth and spread, may bring new
treatment approaches to colorectal and other solid tumors.
"This data is extremely encouraging when evaluating new options for the
treatment of advanced colorectal cancer," said Lee Rosen, M.D., Assistant
Professor, Director of Cancer Therapy Development Program, UCLA. "With more
extensive clinical studies, we hope to define the role of SU5416 in the
prevention of the growth and spread of colorectal and other tumors."
The Phase I/II study presented today evaluated 28 patients to determine
the safety and tolerability of SU5416 when used in combination with 5-FU/LV.
Patients with untreated advanced colorectal cancer were treated with
increasing doses of SU5416 (85 mg/m(2) and 145 mg/m(2)) administered
intravenously twice each week, in combination with standard doses of 5-FU/LV
therapy. In a preliminary analysis of this data, it was shown that patients
receiving SU5416 were found to be free of tumor growth and spread for a median
time in excess of 9.2 months. Of the 28 patients who participated in the
study, data to date show 41 percent had an objective response (either complete
or partial response with 50 percent or greater shrinkage of tumor size).
Safety data has shown no dose-limiting toxicity attributable to SU5416,
with three patients remaining on therapy for more than one year. Toxicities
seen to date are predominantly those known to occur with 5-FU/LV, including
severe nausea, vomiting, diarrhea, mucositis and neutropenia.
SU5416 works by inhibiting angiogenesis. In cancer, angiogenesis is the
process by which tumors create their own blood supply to provide nutrients and
oxygen essential for their growth. Cancerous tumors recruit normal vascular
cells from the body to build these blood vessels. SU5416 is novel because it
interferes with the communication channels between the tumor and healthy cells
in the body. SU5416 does this by blocking 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 depriving the
tumor of necessary nutrients. Scientists hope that this process will starve
tumors, preventing further tumor growth.
Pharmacia/Sugen is also currently conducting a pilot study to evaluate the
safety of SU5416 in combination with CAMPTOSAR(R) (irinotecan hydrochloride
injection), Pharmacia Oncology's flagship chemotherapeutic agent, and 5-FU/LV
for the treatment of metastatic colorectal cancer. Pharmacia/Sugen is also
researching oral forms of SU5416.
"SU5416 and other angiogenesis signaling inhibitors have the potential to
take cancer treatment to the next level," said Jeff Buchalter, Group Vice
President and Head, Global Oncology Franchise, Pharmacia Corporation. "Our
study with CAMPTOSAR and SU5416 in advanced colorectal cancer patients is the
first step in evaluating the potential of this new class of therapy, and
traditional therapies combined."
Also at this meeting, Pharmacia Oncology presented data for other products
in its colorectal cancer franchise. Survival data for CAMPTOSAR -- newly
approved by the U.S. Food and Drug Administration (FDA) as a component of
first-line chemotherapy and considered the new standard of care for first-line
treatment for advanced colorectal cancer -- was presented. Data was also
presented at the meeting on celecoxib, a COX-2 inhibitor, currently being
investigated to determine its potential to decrease the occurrence of new
adenomatous polyps (non-cancerous polyps occurring in the colon that can turn
malignant).
Pharmacia Oncology is bringing discovery to life for every person touched
by cancer. The current oncology portfolio includes CAMPTOSAR(R) (irinotecan
hydrochloride injection), AROMASIN(R) (exemestane tablets); ELLENCE(TM)/
FARMORUBICIN(R) (epirubicin 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. Celecoxib, a COX-2 specific inhibitor is currently in clinical trials
to investigate its role in inhibiting the formation of colorectal cancer
cells. CELEBREX(TM) (celecoxib capsules) has been approved to reduce the
number of adenomatous colorectal polyps in patients with familial adenomatous
polyposis (FAP) as an adjunct to usual care (endoscopic surveillance and
surgery). Celecoxib is also being investigated across a variety of human
tumors.
Pharmacia Corporation (NYSE: PHA) is a leading global pharmaceutical
company created through the merger of Pharmacia & Upjohn with Monsanto Company
and its G.D. Searle unit. Pharmacia has a broad product portfolio, a robust
pipeline of new medicines, and an annual investment of more than $2 billion in
pharmaceutical research and development.
Certain statements contained in this release, such as statements
concerning the Company's anticipated financial results, current and new
product performance, currency impact and other non-historical facts are
"forward-looking statements" (as such term is defined in the Private
Securities Litigation Reform Act of 1995). Since these statements are based
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;
fluctuations in exchange rates; the effects of the Company's accounting
policies and general changes in generally accepted accounting principles; the
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.
SOURCE Pharmacia Corporation
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