While Tysabri has been voluntarily suspended by association with PML,
makers Biogen and Elan have kept right on releasing trial data showing
Tysabri to be a generally efficacious and well-tolerated treatment for
both multiple sclerosis and Crohn's disease, an auto-immune disorder of
the digestive tract.
The following trial was completed just prior to the suspension. Besides
the obvious efficacy against Crohn's, the highly interesting tidbit
relevant to MS'ers is that:
"There were no notable differences in the overall rates of adverse
events or serious adverse events between the TYSABRI and placebo
treatment groups. The most common adverse events seen in the trial
were headache, nausea, abdominal pain and nasopharyngitis."
Again, no rise in the rate of opportunistic infections, of which PML is
but one. This was a monotherapy trial (Tysabri alone), so this is a bit
of a boost in favor of the theory that Tysabri alone does not increase
the risk of PML. But the mystery remains: Why was PML seen in the 3
publicized cases-- and nothing else? Or another way of looking at it:
What is special about PML in deference to other infections of the CNS?
At this point, it is awfully difficult to draw a straight line between
the risk of PML and dosing of Tysabri *alone*-- and while it will be
interesting to see how this ultimately plays out, it is clear that
Tysabri has a great deal of benefit to offer to autoimmune sufferers.
We can only hope this entire situation comes to a speedy resolution
that, in deference to its efficacy, restores a formidable new weapon in
the arsenal against MS-- with whatever additional warnings, screenings,
and regulations as necessary to provide reasonable protection against
PML infection. Risk and reward tradeoffs are a part of every person's
life who is afflicted with a disease, and it is quite difficult to
see study after study touting Tysabri's utility and realize it was just
within our reach. Here's to hoping that the risk part of the equation
is defined quickly and completely.
"These data provide further evidence of the benefit of TYSABRI in
treating immune-mediated diseases. We are committed to a thorough
safety evaluation so we can better define the benefit-risk profile of
TYSABRI. We hope to have findings from the evaluation by the end of
the summer," said Burt Adelman, MD, executive vice president,
Development, Biogen Idec."
Click 'read more' to see the details of this newly released Crohn's study...
| Press Release | Source:
Elan Corporation and Biogen Idec |
TYSABRI(R) Phase III Induction Trial in Crohn's Disease Meets Primary Endpoint
Thursday June 30, 2:30 am ET
TYSABRI Induced Statistically Significant Response and Remission in Patients with Active Disease
DUBLIN, Ireland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 30,
2005--
Study Showed Reduction in Signs and Symptoms of Crohn's Disease;
Ongoing Safety Evaluation Remains on Track
Elan Corporation, plc and Biogen Idec announced today that ENCORE,
the second Phase III induction trial of TYSABRI® (natalizumab) for
the treatment of moderately to severely active Crohn's disease (CD) in
patients with evidence of active inflammation, met the primary
endpoint of clinical response as defined by a 70 point decrease in
baseline Crohn's Disease Activity Index (CDAI) score at both weeks 8
and 12.
In addition, ENCORE met all of its secondary endpoints including
clinical remission at both weeks 8 and 12. Clinical remission was
defined as achieving a CDAI score of equal to or less than 150 at both
weeks 8 and 12.
There were no notable differences in the overall rates of adverse
events or serious adverse events between the TYSABRI and placebo
treatment groups. The most common adverse events seen in the trial
were headache, nausea, abdominal pain and nasopharyngitis.
On February 28, 2005, Elan Corporation, plc and Biogen Idec
announced that they voluntarily suspended TYSABRI from the U.S. market
and all ongoing clinical trials. This decision was based on reports of
progressive multifocal leukoencephalopathy (PML), a rare and
potentially fatal, demyelinating disease of the central nervous
system. Elan and Biogen Idec's comprehensive safety evaluation
concerning TYSABRI and any possible link to PML is ongoing. At the
time of the dosing suspension, all ENCORE study patients had completed
dosing based on the study protocol and collection and analysis of data
followed.
The full data from ENCORE, including further sub-analysis of
response and remission rates as well as clinical effect at other time
points, effect on inflammatory markers and quality of life data will
be presented at an upcoming medical meeting.
"The results of the ENCORE study are encouraging because patients
treated with TYSABRI achieved a significant improvement in symptoms of
this devastating, chronic immune disease," said Lars Ekman, MD,
executive vice president and president, Research and Development,
Elan. "Patient safety remains our top priority. We plan to share the
data from ENCORE and our other Phase III TYSABRI Crohn's studies with
the FDA and other regulatory agencies to determine the appropriate
path forward for TYSABRI as a potential new treatment option for this
underserved patient population."
"These data provide further evidence of the benefit of TYSABRI in
treating immune-mediated diseases. We are committed to a thorough
safety evaluation so we can better define the benefit-risk profile of
TYSABRI. We hope to have findings from the evaluation by the end of
the summer," said Burt Adelman, MD, executive vice president,
Development, Biogen Idec.
The ENCORE Study
ENCORE was a Phase III, international, double-blind,
placebo-controlled study of 510 patients at 114 sites to evaluate the
safety and efficacy of intravenous TYSABRI in patients with moderately
to severely active Crohn's disease (based on a confirmed diagnosis of
CD and a CDAI score of greater than or equal to 220 and less than or
equal to 450) and evidence of active inflammation (as evidenced by
elevated C-reactive protein (CRP) levels of CRP greater than 2.87
mg/l, the upper limit of normal). Patients were randomized 1:1 to
treatment with TYSABRI (300mg) or placebo infusions at weeks 0, 4, and
8. Efficacy and safety assessments were performed at weeks 4, 8 and
12, and the study remains ongoing for safety follow-up.
About TYSABRI
Elan and Biogen Idec are collaborating equally on the development
of TYSABRI in MS, Crohn's disease, and rheumatoid arthritis. On
February 28, 2005, Biogen Idec and Elan announced that they
voluntarily suspended TYSABRI from the U.S. market and all ongoing
clinical trials. Worldwide regulatory agencies are being kept informed
of developments related to TYSABRI.
About Crohn's Disease
Approximately one million people worldwide have Crohn's disease, a
chronic and progressive inflammatory disease of the gastrointestinal
tract, which commonly affects both men and women. The disease usually
causes diarrhea and crampy abdominal pain, often fever, and at times
rectal bleeding. Loss of appetite and weight loss also may occur.
Complications include narrowing of the intestine, obstruction,
abscesses, and fistulas (abnormal channels connecting the intestine
and other organs, including the skin), malnutrition and decreased
growth rate in children.
About Elan
Elan Corporation (NYSE: ELN - News), plc is a neuroscience-based
biotechnology company. We are committed to making a difference in the
lives of patients and their families by dedicating ourselves 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 http://www.elan.com.
About Biogen Idec
Biogen Idec (NASDAQ: BIIB - News) creates new standards of care in
oncology, neurology and immunology. As a global leader in the
development, manufacturing, and commercialization of novel therapies,
Biogen Idec transforms scientific discoveries into advances in human
healthcare. For product labeling, press releases and additional
information about the company, please visit http://www.biogenidec.com.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding
the potential for TYSABRI. These statements are based on the
companies' current beliefs and expectations, and are subject to risks
and uncertainties that could cause actual results to differ
materially. There is no assurance, for example, that all experiences
with TYSABRI will be the same or that the potential for TYSABRI will
not be affected by unexpected new data or technical issues. The is no
assurance that PML is not caused by TYSABRI, that there are not or
will not be more PML cases or other serious adverse events associated
with TYSABRI or that we will be able to gain sufficient information to
fully understand the risks associated with TYSABRI. There is also no
assurance that the companies will be able to resume marketing and
sales of TYSABRI in any indication. For more detailed information on
the risks and uncertainties associated with TYSABRI and the companies'
drug development and other activities, see the periodic and other
reports of Biogen Idec Inc. and Elan Corporation, plc 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.
Contact:
Media Contacts:
Elan
Davia B. Temin or Brian McGlynn, 212-407-5740
Jim Milton, 353-1-498-0300
or
Biogen Idec
Amy Brockelman, 617-914-6524
or
Investor Contacts:
Elan
Emer Reynolds, 353-1-709-4000
800-252-3526
or
Biogen Idec
Oscar Velastegui, 617-679-2812
Source:
Elan Corporation and Biogen Idec
