First Multiple Myeloma Patient Treated
Elan Corporation PLC
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.
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
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