CHAMPIONS To Be Extended To 10 Years
CAMBRIDGE, Mass., Sept. 22 /PRNewswire-FirstCall/ -- Biogen, Inc.
(Nasdaq: BGEN) announced today that AVONEX(R) (Interferon beta-1a) was shown
to alter the long-term course of multiple sclerosis (MS) in patients who began
treatment immediately after their initial MS attack compared to initiation of
treatment more than two years after onset of symptoms. The patients studied
were considered at risk of suffering additional MS attacks because of the
presence of brain MRI scan abnormalities. The study, known as CHAMPIONS
(Controlled High Risk AVONEX Multiple Sclerosis Prevention Study In Ongoing
Neurological Surveillance), was designed to determine whether the effect of
early treatment with AVONEX in delaying relapses and reducing the accumulation
of MS brain lesions could be sustained for up to five years. These five-year
data were presented at the European Committee for Treatment and Research in MS
(ECTRIMS) meeting in Milan, Italy.
(Logo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
In addition, Biogen announced today that the CHAMPIONS study will be
extended for an additional five years, which will determine if the effects of
early treatment can be sustained for up to 10 years.
"These CHAMPIONS data show that therapy should be initiated as early as
possible," said lead study investigator R. Philip Kinkel, M.D., Director of
the Multiple Sclerosis Center at Beth Israel Deaconess Medical Center in
Boston, MA and Associate Professor of Neurology at Harvard Medical School.
"This study confirms for me that AVONEX works well for patients over the long
term. I am very pleased that Biogen has decided to extend this important MS
research in order to gain further insight on how patients treated very early
with AVONEX do over a 10-year period."
About the Study
CHAMPIONS is an open-label extension of CHAMPS, a randomized, double-
blind, placebo-controlled Phase III clinical trial involving 383 patients who
had just experienced their first MS attack and who had brain MRI scan
abnormalities characteristic of MS. In CHAMPS, AVONEX-treated patients
experienced a 44% decrease in the rate of developing a second attack when
compared to placebo over a three-year period. Based on the CHAMPS results,
the U.S. Food and Drug Administration (FDA) and the European Medicines
Evaluation Agency (EMEA) approved AVONEX to be used in patients who have
experienced a first clinical episode if they have brain MRI scan abnormalities
consistent with MS.
The 203 MS patients who enrolled in the CHAMPIONS study were followed for
a total of five years after their initial attack. Patients who began treatment
with AVONEX immediately after their first attack had a 35% decrease in the
rate of developing a second attack and a 42% reduction in the median number of
new or enlarging T2 hyperintense lesions, when compared to patients who began
treatment with placebo. All of the patients in the CHAMPIONS study had
received AVONEX or placebo in the CHAMPS study. At the start of CHAMPIONS,
154 patients were continuing AVONEX treatment, 14 patients were taking another
treatment, and 35 patients were not on any therapy.
"MS is a chronic disease that requires therapies which can be used over a
patient's lifetime," said Burt Adelman, M.D., Executive Vice President,
Research and Development, Biogen. "AVONEX is the first treatment to be
approved in the United States and Europe for patients with MS at its earliest
stage. Now we have even more data demonstrating that early initiation with
AVONEX can have a positive impact on the lives of people with MS."
Multiple Sclerosis
MS is a chronic disease of the central nervous system that affects
approximately 400,000 people in North America and approximately 1 million
people worldwide. It is a disease of young adults, mostly women, with onset
typically between 20 and 40 years of age. Symptoms of MS may include vision
problems, loss of balance, numbness, difficulty walking and paralysis.
The first sign that a patient may have MS is a single, clinical event,
such as blurred vision, loss of balance, numbness, extreme fatigue, poor
coordination, slurred speech or tremors. Until recently, the standard
practice has been to treat MS only after patients experience at least two
clearly defined events.
About AVONEX
AVONEX is the leading treatment for relapsing forms of multiple sclerosis
worldwide, with more than 120,000 patients on therapy. It was launched in the
U.S. in 1996 and later in Europe for the treatment of relapsing forms of MS to
slow the progression of disability and reduce relapses. AVONEX is marketed
internationally in more than 65 countries. AVONEX was the first treatment
approved for MS patients who have their first clinical MS attack and have a
brain MRI scan that suggests MS; this use was approved in Europe in 2002 and
in the U.S. in 2003.
The most common side effects associated with AVONEX treatment are flu-like
symptoms including myalgia, fever, fatigue, headache, chills, nausea,
vomiting, pain and asthenia.
AVONEX should be used in caution with patients with depression or other
mood disorders and in patients with seizure disorders. AVONEX should not be
used by pregnant women. Patients with cardiac disease should be closely
monitored. Patients should also be monitored for signs of hepatic injury.
Routine periodic blood chemistry and hematology tests are recommended during
treatment with AVONEX. Rare cases of anaphylaxis have been reported. Please
see complete prescribing information available at http://www.AVONEX.com.
About Biogen
Biogen is the world's oldest independent biotechnology company and a
leader in biologics research, development and manufacturing. A pioneer in
leading edge research in immunology, neurobiology and oncology, Biogen brings
novel therapies to improve patients' lives around the world through its global
marketing capabilities. For press releases and additional information about
the company, please visit http://www.biogen.com.
Media Contact:
Amy Brockelman
Manager, Public Affairs
Biogen, Inc.
Tel: (617) 914-6524
Investment Community Contact:
Elizabeth Woo
Senior Director, Investor Relations
Biogen, Inc.
Tel: (617) 679-2812
SOURCE Biogen, Inc.
 back to top
Related links:
http://www.biogen.com
Company News On-Call:
http://www.prnewswire.com/comp/101550.html
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
CONTACT:
Media Contact: Amy Brockelman, Manager,
Public Affairs, +1-617-914-6524, or Investment Community Contact:
Elizabeth Woo, Senior Director, Investor Relations,
+1-617-679-2812, both of Biogen, Inc.
|
