Abbott (ticker: ABT, exchange: New York Stock Exchange (.N))
News Release -
Meta-Analysis Results Presented at ASCO Show Statistically Significant Delay in Time to Disease Progression for Advanced Prostate Cancer Patients Taking Atrasentan
-- Studies of Investigational Anti-Cancer Drug Currently Ongoing --
NEW ORLEANS, June 5 /PRNewswire-FirstCall/ -- An analysis examining pooled
data from two clinical studies of atrasentan shows a statistically significant
(p=0.013) delay in time to disease progression in men with metastatic, hormone
refractory prostate cancer who took the drug versus those who took placebo.
Analyzed separately these studies trended toward atrasentan, but did not show
The data were presented today by Michael A. Carducci, M.D., Johns Hopkins
Kimmel Cancer Center at the American Society of Clinical Oncology (ASCO)
Atrasentan is an oral, non-hormonal, non-chemotherapy investigational
anti-cancer agent. Prostate cancer is the most common solid tumor in American
men. An estimated 230,000 men will be diagnosed with prostate cancer and
29,000 will die from the disease this year in the United States.
"These meta-analysis results are encouraging and show that atrasentan
holds promise for the treatment of metastatic, hormone-refractory prostate
cancer," said Perry Nisen, M.D. Ph.D., divisional vice president, Global
Oncology Development at Abbott Laboratories.
Meta-Analysis of M96-594 & M00-211
To examine the overall treatment effect of atrasentan in men with
metastatic, hormone refractory prostate cancer, Abbott conducted a simple
retrospective pooling of its two large, randomized, well-controlled clinical
trials (M96-594 & M00-211) with a total patient population of 1097. Results
pooled from two different atrasentan doses (2.5mg and 10mg) demonstrate a
statistically significant (p=0.013) delay in time to disease progression in
the intent to treat analysis for men taking atrasentan vs. placebo.
The two individual studies pooled for the meta-analysis tested the same
patient population with similar baseline demographics, used the same endpoint
of time to disease progression (radiographic progression was more explicitly
defined in the M00-211 protocol) and were placebo-controlled and double blind.
Abbott has conducted statistical tests for heterogeneity of the studies and on
the overall treatment effect to support the rigor of the meta-analysis.
Atrasentan (10mg) was generally well tolerated in both studies among all
patients. The most common associated adverse events for atrasentan vs.
placebo were, headache (21 percent vs. 13 percent), peripheral edema (39
percent vs. 13 percent), and rhinitis (34 vs. 14 percent) respectively.
"A meta-analysis is a useful tool in assessing modest but nevertheless
clinically important treatment effects. The combined results from these
studies are very encouraging and suggest atrasentan may be an exciting novel
treatment option which targets the endothelin axis," said Professor David
Dearnaley, MD, FRCP, Institute of Cancer Research/Royal Marsden Hospital.
"These are the first trials to explore the benefit of the endothelin-A
receptor antagonists in hormone refractory prostate cancer and give rise to
optimism than an entirely different class of agents may be valuable after
failure of conventional treatments."
Atrasentan, an oral, once-daily, non-hormonal, non-chemotherapy,
anti-cancer agent, belongs to a class of compounds known as selective
endothelin-A receptor antagonists, or SERAs. SERAs antagonize the effect of
endothelin (ET-1), one of the proteins thought to be involved in the
stimulation of the spread of cancer cells. Atrasentan is the result of
Abbott's discovery effort in oncology.
Atrasentan has been studied in Phase II and Phase III clinical trials in
patients with metastatic, hormone refractory prostate cancer. It is currently
in its second Phase III pivotal trial (M00-244) involving men with prostate
cancer that has not spread (non-metastatic). It is also being evaluated in a
Phase II trial (M01-366) in men with rising prostate-specific antigen (PSA)
following prostate cancer surgery. Additionally, Abbott continues to support
the investigation of atrasentan in other cancers including kidney, ovarian,
brain, and non-small-cell lung cancers.
Atrasentan has been granted fast track review status from the U.S. Food
and Drug Administration (FDA).
About Abbott Laboratories
Abbott Laboratories is committed to the discovery and development of
innovative treatments to help patients in the fight against cancer. Abbott's
oncology research is focused on developing targeted, less toxic therapies than
are currently available. The company has several different classes of
compounds in various stages of clinical development. These approaches address
multiple phases of cancer progression, including angiogenesis (new blood
vessel formation), signal transduction and programmed cell death (apoptosis).
Abbott's Oncology Franchise extends beyond pharmaceutical research to
supportive care products and diagnostics. Abbott currently manufactures
products for pain management, including patient-controlled analgesia pumps,
and markets tests for detection of cancer, including a PSA test. Abbott's
innovative genomic tests include Vysis(R) UroVysion, for monitoring the
recurrence of bladder cancer, and PathVysion(R), for detecting the HER-2 gene,
which predicts potential treatment benefit in women with breast cancer.
Abbott also markets nutritional products designed to meet the unique dietary
needs of cancer patients.
Abbott Laboratories is a global, broad-based health care company devoted
to the discovery, development, manufacture and marketing of pharmaceuticals
and medical products, including nutritionals, devices and diagnostics. The
company employs more than 55,000 people and markets its products in more than
SOURCE Abbott Laboratories
/CONTACT: U.S. Media, Catherine Bryan, +1-847-938-8551, or Cell,
+1-312-209-0250, Media Outside the U.S., Brian Kyhos, +1-847-936-7988, or
Financial Community, John Thomas, +1-847-938-2655, all of Abbott Laboratories/
/Company News On-Call: http://www.prnewswire.com/comp/110328.html /
/Web site: http://www.abbott.com /
CO: Abbott Laboratories; American Society of Clinical Oncology (ASCO) annual
ST: Louisiana, Illinois
IN: HEA MTC
SU: SVY TDS
-- CGSA002 --
8417 06/05/2004 17:30 EDT http://www.prnewswire.com