|
|
|
|
|
terug |
Datum nieuwsfeit: 05-09-2008
Elan en Biogen Idec initiëren eerste klinisch onderzoek TYSABRI in oncologie
( BW)(MA-BIOGEN-IDEC/ELAN)(ELN)(BIIB) Elan and Biogen Idec Initiate
First Clinical Trial of TYSABRI(R) in Oncology
First Multiple Myeloma Patient Treated
Business Editors/Health/Medical Writers
CAMBRIDGE, Mass. & DUBLIN, Ireland--(BUSINESS WIRE)--Sept. 5,
2008--Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB)
today announced the initiation of the first clinical trial of
TYSABRI(R) (natalizumab) in oncology. The first dose of TYSABRI was
administered yesterday in the trial. The objectives of this Phase I/II
study are to evaluate the safety and potential anti-tumor activity of
TYSABRI in patients with relapsed or refractory multiple myeloma.
TYSABRI is a recombinant, humanized monoclonal antibody that targets
the adhesion molecule VLA4 (also known as alpha-4 integrin) that is
expressed on the surface of many types of immune cells. VLA4 is also
found on the surface of multiple myeloma cells and may be involved in
their survival.
"We are excited to initiate the oncology clinical trial program
for TYSABRI," said Wayne Saville, MD, Director, Oncology Medical
Research at Biogen Idec. "TYSABRI has potential in multiple myeloma
and a number of other cancers through its action as a blocker of VLA4.
It is a meaningful addition to Biogen Idec's robust oncology
pipeline."
"This clinical trial in oncology represents an opportunity for
TYSABRI to continue to address unmet medical needs, potentially
bringing new therapeutic options to patients and their oncologists,"
said Gordon Francis, MD, Senior Vice President, Global Clinical
Development at Elan Pharmaceuticals, Inc.
About the Trial
This Phase I/II, open-label, two-arm study is designed to evaluate
the safety and anti-tumor activity of TYSABRI in patients with
relapsed or refractory multiple myeloma. In the Phase I portion of the
trial, a standard dose-escalation design will be used to assess the
safety and tolerability of TYSABRI in up to 12 patients. In the Phase
II portion of the study, up to 30 patients will be randomized to the
tolerated doses identified in Phase I of the study.
Treatment cycles will consist of intravenous infusions of TYSABRI
once every 28 days for 6 months. After 6 months, if the patient has
achieved a partial or a complete response, he or she may continue to
receive TYSABRI once every 28 days until progression of disease
occurs.
Patients eligible for the study must be at least 18 years of age
with relapsed or refractory multiple myeloma who have failed or cannot
tolerate therapy with bortezomib and thalidomide or lenalidomide.
About Multiple Myeloma
Multiple myeloma is a cancer of the plasma cell, an important part
of the immune system that produces antibodies to help fight infection
and disease. Certain immune cells, called B cells, change into plasma
cells when they respond to an antigen, producing antibodies to attack
bacteria and viruses. However, when plasma cells multiply in an
uncontrolled way, they can produce tumors, which generally develop in
the bone marrow. These plasma cells produce excessive amounts of
antibodies and can interfere with normal blood-forming functions of
the bone marrow, crowding out healthy cells and leaving patients
susceptible to anemia, hemorrhage, infection and severe osteoporosis.
Multiple myeloma is the second most common blood cancer in the
United States (US). More than 50,000 people in the US are living with
multiple myeloma, and about 20,000 new cases are expected to be
diagnosed this year. Nearly 11,000 Americans are expected to die from
the disease this year. Men are 50 percent more likely to develop the
disease than women. Other risk factors include race, radiation
exposure, family history, occupational exposure to petroleum, obesity
and other plasma cell disorders.
About TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the
United States and relapsing-remitting MS in the European Union.
According to data that have been published in the New England Journal
of Medicine, after two years, TYSABRI treatment led to a 68% relative
reduction (p<0.001) in the annualized relapse rate compared to placebo
and reduced the relative risk of disability progression by 42-54%
(p<0.001).
TYSABRI was recently approved to induce and maintain clinical
response and remission in adult patients with moderately to severely
active Crohn's disease (CD) with evidence of inflammation who have had
an inadequate response to, or are unable to tolerate, conventional CD
therapies and inhibitors of TNF-alpha.
TYSABRI increases the risk of progressive multifocal
leukoencephalopathy (PML), an opportunistic viral infection of the
brain that usually leads to death or severe disability. Cases of PML
have been reported in patients taking TYSABRI who were recently or
concomitantly treated with immunomodulators or immunosuppressants, as
well as in patients receiving TYSABRI as monotherapy. Other serious
adverse events that have occurred in TYSABRI-treated patients included
hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious
opportunistic and other atypical infections have been observed in
TYSABRI-treated patients, some of whom were receiving concurrent
immunosuppressants. Herpes infections were slightly more common in
patients treated with TYSABRI. In MS and CD clinical trials, the
incidence and rate of other serious adverse events, including serious
infections, were similar in patients receiving TYSABRI and those
receiving placebo. Common adverse events reported in TYSABRI-treated
MS patients include headache, fatigue, infusion reactions, urinary
tract infections, joint and limb pain and rash. Other common adverse
events reported in TYSABRI-treated CD patients include respiratory
tract infections and nausea. Clinically significant liver injury has
been reported in patients treated with TYSABRI in the post-marketing
setting.
TYSABRI is approved in more than 35 countries.
For more information about TYSABRI please visit www.tysabri.com,
www.biogenidec.com or www.elan.com or call 1-800-456-2255.
About Elan
Elan Corporation, plc is a neuroscience-based biotechnology
company committed to making a difference in the lives of patients and
their families by dedicating itself to bringing innovations in science
to fill significant unmet medical needs that continue to exist around
the world. Elan shares trade on the New York, London and Dublin Stock
Exchanges. For additional information about the company, please visit
www.elan.com.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas
with high unmet medical needs. Founded in 1978, Biogen Idec is a
global leader in the discovery, development, manufacturing, and
commercialization of innovative therapies. Patients in more than 90
countries benefit from Biogen Idec's significant products that address
diseases such as lymphoma, multiple sclerosis, and rheumatoid
arthritis. For product labeling, press releases and additional
information about the company, please visit www.biogenidec.com.
Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements regarding
the potential use of TYSABRI. These statements are based on the
companies' current beliefs and expectations. The development of
TYSABRI in new indications and its commercial potential are subject to
a number of risks and uncertainties. Factors which could cause actual
results to differ materially from the companies' current expectations
include but are not limited to the risk that we may be unable to
adequately address concerns or questions raised by FDA or other
regulatory authorities, that concerns may arise from additional data,
that the incidence and/or risk of PML or other opportunistic
infections in patients treated with TYSABRI may be higher than
observed in clinical trials, or that the companies may encounter other
unexpected hurdles. Drug development and commercialization involves a
high degree of risk.
For more detailed information on the risks and uncertainties
associated with the companies' drug development and other activities,
see the periodic and current reports that Biogen Idec and Elan have
filed with the Securities and Exchange Commission. The companies
assume no obligation to update any forward-looking statements, whether
as a result of new information, future events or otherwise.
--30--
CONTACT: MEDIA CONTACTS:
Biogen Idec
Naomi Aoki, 617-914-6284
or
Elan
Jonathan Birt, 212-850-5664 or +44 20 7269 7205
or
Niamh Lyons, +353 1 663 3602
or
INVESTOR CONTACTS:
Biogen Idec
Eric Hoffman, 617-679-2812
or
Elan
Chris Burns, 800-252-3526
or
David Marshall, +353 1 709 4444
Disclaimer: Deze bekendmaking is officieel geldend in de originele
brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten
worden vergeleken met de tekst in de brontaal welke als enige,
juridische geldigheid beoogt.