|
|
 | | | |
- close
- close
- close
- close
| |||||||||
This excerpt taken from the ELN 6-K filed Apr 2, 2009. DUBLIN, Ireland and COLLEGEVILLE, Pa.
– April 2, 2009 – Elan Corporation, plc (NYSE: ELN) and Wyeth (NYSE: WYE)
today announced that the companies will discontinue the highest of three dosing
regimens, 2.0 mg/kg, in the two ongoing Phase 3 studies of bapineuzumab in
patients with mild to moderate Alzheimer’s disease (AD) who do not carry the
Apolipoprotein E4 (ApoE4) allele (non-carriers). ApoE4 is a known
genetic risk factor for development of AD. The 0.5 mg/kg and 1.0
mg/kg doses in these two trials will continue as planned.
This
decision has no impact on two other ongoing studies, which are testing a
single 0.5 mg/kg dose of bapineuzumab in patients
who carry the ApoE4 allele (carriers). No changes are planned for
these two carrier studies. The Phase 3 program for bapineuzumab is
the largest clinical program ever initiated in Alzheimer’s
disease. It is expected that approximately 4,000 patients will be
included across all four studies. 1
The
decision of the companies to discontinue the 2.0 mg/kg dose was made in
concurrence with the study’s independent Safety Monitoring Committee (SMC),
following its review of vasogenic edema (VE) in the ongoing Phase 3 clinical
program. The SMC also reviewed unblinded data regarding VE from the
0.5 mg/kg and 1.0 mg/kg dose cohorts in the non-carrier studies and does not
have concerns about these cohorts at this time.
“Alzheimer’s
disease is a devastating condition and the development of new therapies that
have the potential to slow progression of the illness is critical,” said Elan
President Carlos Paya, MD, PhD. “Our review of the safety data and
the feedback from the Safety Monitoring Committee made it clear that continued
development of the highest dose was not advisable. The decision to
remove the highest dose from development reduces risk to patients and it also
helps to reduce risk to the overall development effort.”
Moving
forward, newly enrolled patients will be randomized to either the 0.5 mg/kg or
the 1.0 mg/kg dose cohorts or to placebo. In consultation with the
SMC, the companies plan to amend the protocols to allow patients who are
currently receiving the 2.0 mg/kg dose to be reassigned to the 1.0 mg/kg
dose.
Wyeth and
Elan’s decision to modify the dosing regimen for two of the four ongoing Phase 3
studies is being communicated to study investigators and the Boards of Health
where the clinical trials are being conducted.
About
Vasogenic Edema
Vasogenic
edema is an accumulation of water in brain tissue, possibly related to changes
in blood vessel permeability. VE is most frequently detected on MRI
scans in asymptomatic patients exposed to bapineuzumab, but may be associated
with symptoms in some patients. In a Phase 2 trial of
bapineuzumab, VE was observed more frequently in patients who were carriers of
the ApoE4 allele and was more likely to occur at higher doses of
bapineuzumab. 2
About
the Global Bapineuzumab Phase 3 Clinical Trial Program
The
global bapineuzumab Phase 3 program was initiated in December 2007 and includes
four randomized, double-blind, placebo-controlled studies. Two of
these studies test bapineuzumab in carriers of the ApoE4 allele (one in North
America; one internationally) and two studies test bapineuzumab in non-carriers
(one in North America; one internationally). The two non-carrier
trials were originally anticipated to enroll approximately 1,250 patients
each. With the removal of the 2.0 mg/kg dose group, it is now
expected that the studies will each have approximately 1,000 patients for
efficacy evaluation. We continue to anticipate that the two carrier
trials, which only test the 0.5 mg/kg dose,
will enroll approximately 800 patients each; this is unchanged with today’s
announcement.
About
the Elan and Wyeth Collaboration
The Wyeth
and Elan Alzheimer's Immunotherapy Program (AIP) includes investigational
clinical programs for bapineuzumab. AIP is a collaboration between
the two companies to research, develop and commercialize immunotherapeutic
approaches that may be used to treat and possibly prevent the onset of
Alzheimer’s disease. AIP research focuses on the beta amyloid
hypothesis, as the companies believe that enhancing the clearance of beta
amyloid in the brain may provide a new treatment approach for Alzheimer’s
disease.
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 http://www.elan.com.
3
About
Wyeth
Wyeth
(NYSE:WYE) is one of the world’s largest research-driven pharmaceutical and
health care products companies. It is a leader in the discovery,
development, manufacturing and marketing of pharmaceuticals, vaccines,
biotechnology products, nutritionals and non-prescription medicines that improve
the quality of life for people worldwide. The Company’s major divisions
include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
Health.
Safe
Harbor/Forward-Looking Statements
The
statements in this press release regarding the clinical program for bapineuzumab
are forward-looking statements that are subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or implied
by such statements. In particular, there can be no assurance that the
clinical program for bapineuzumab will be successful in demonstrating safety
and/or efficacy, that we will not encounter problems or delays in clinical
development, or that bapineuzumab will ever receive regulatory approval or be
successfully commercialized. Other risks and uncertainties that could
cause actual results to differ materially from those expressed or implied by
these forward-looking statements include those detailed from time to time in the
companies’ periodic reports filed with the Securities and Exchange Commission,
including Wyeth`s current reports on Form 8-K, quarterly reports on Form 10-Q
and annual report on Form 10-K, particularly the discussion under the caption
"Item 1A, Risk Factors" in Wyeth`s Annual Report on Form 10-K for the year ended
December 31, 2008, which was filed with the Securities and Exchange Commission
on February 27, 2009, and Elan’s Reports of Foreign Issuer on Form 6-K and
Annual Report on Form 20-F, particularly the discussion under the caption “Item
3D, Risk Factors” in Elan’s Annual Report on Form 20-F for the year ended
December 31, 2008, which was filed with the Securities and Exchange Commission
on February 26, 2009 The forward-looking statements in this press release
are qualified by these risk factors. The companies assume no obligation to
publicly update any forward-looking statements, whether as a result of new
information, future developments or otherwise.
Source:
Elan Corporation, plc and Wyeth
# #
#
4
|