ate-Stage Testing by Launching Two Global Trials
INDIANAPOLIS, May 21 /PRNewswire-AsiaNet/ --
HOLD UNTIL 21/05/2009 07:00 NEW YORK TIME
Both Phase III pivotal trials begin enrollment in May 2009; Reinforces
Lilly’s commitment to Alzheimer’s disease and biotech product research
Eli Lilly and Company (NYSE: LLY) today announced it will begin enrolling
patients this month in two separate but identical Phase III clinical trials of
solanezumab(i), previously referred to as LY2062430, an anti-amyloid beta
monoclonal antibody being investigated as a potential treatment to delay the
progression of mild to moderate Alzheimer’s disease. The trials, called
EXPEDITION and EXPEDITION 2, will each include a treatment period that lasts 18
months and are expected to enroll a total of 2,000 patients age 55 and over
from 16 countries.
In 2008, Lilly began enrolling patients in two Phase III clinical trials
called IDENTITY and IDENTITY 2 for a different potential treatment for
Alzheimer’s disease, a gamma-secretase inhibitor that also affects amyloid
beta, which is believed to be one of the underlying pathologies of the disease.
Patients or caregivers interested in learning how to enroll in either
EXPEDITION trial or the IDENTITY trials should visit www.clinicaltrials.gov or
call 1-877-CTLilly (1-877-285-4559). In combination, the EXPEDITION and
IDENTITY trials will include approximately 4,600 patients with Alzheimer’s
disease in over 30 countries around the world.
EXPEDITION and EXPEDITION 2 ? EXPanding AlzhEimer’s Disease InvestigaTIONs
The EXPEDITION clinical trials are identical multicenter, randomized,
double-blind, placebo-controlled trials. Patients enrolled in the trials will
be randomized in a 1:1 ratio (500 patients in each trial arm) to receive
intravenous infusions of either placebo or 400 mg of solanezumab once every
four weeks. Patients who are taking currently available symptomatic treatments
for Alzheimer's disease can continue treatment during their participation in
the EXPEDITION trials. The primary objective of both trials is to test whether
solanezumab will slow the cognitive and functional decline of Alzheimer’s
disease patients as compared with placebo. These outcomes will be analyzed
using measures of the Alzheimer's Disease Assessment Scale-Cognitive subscore
(ADAS-COG(11)), which measures cognitive function with an emphasis on memory,
and the Alzheimer’s Disease Cooperative Study - Activities of Daily Living
scale (ADCS-ADL), which measures the ability to independently perform daily
activities such as eating, bathing, and using the telephone. Secondary
objectives of the trials include different clinical benefits as measured by
several brain-scanning and biochemical biomarkers and ratings scales, and
quality of life impact.
“Current therapies available to treat Alzheimer’s disease may help with
symptoms, but they haven’t been proven to change the disease progression,” said
Eric Siemers M.D., Medical Director, Alzheimer’s disease research for Eli Lilly
and Company. “Biomarker results from a Phase II solanezumab trial give us hope
that Lilly is on a path toward a treatment that may slow the rate of
progression of Alzheimer’s disease.”
EXPEDITION will be conducted in Argentina, Brazil, Canada, Japan, and
United States. EXPEDITION 2 will be conducted in Australia, France, Germany,
Italy, Japan, Korea, Poland, Russia, Spain, Sweden, Taiwan, United Kingdom, and
United States.
About Alzheimer's Disease
Alzheimer's disease is a progressive neurodegenerative condition that is
the most common cause of dementia, accounting for 60 to 80 percent of
cases(ii). Estimates show that 6-8 percent of people over age 65 are affected
by Alzheimer's disease(iii), totaling approximately 5.3 million people in the
United States alone(ii). Every 70 seconds, an American is developing
Alzheimer's disease(ii), and it is the sixth-leading cause of death in the
United States(ii). The direct and indirect health care costs associated with
Alzheimer's disease and other dementias in the U.S. are estimated to be about
$150 billion(ii). In 2005, the total cost worldwide of dementia, of which
Alzheimer’s disease is the most common cause, was estimated at $315.4
billion(iv). The burden to caregivers and health care costs can increase
dramatically in the late stages of Alzheimer's disease, when patients cannot
maintain independent function and are frequently bedridden(ii).
About Solanezumab
Alzheimer’s disease theory suggests that amyloid beta clumps together and
eventually kills brain cells. Solanezumab binds specifically to soluble amyloid
beta and thereby may draw the peptide away from the brain through the blood.
In short-term clinical studies, solanezumab appeared to have dose-dependent
effects on amyloid beta in blood and cerebrospinal fluid. The clinical studies
to date have been too short to evaluate any potential delay in the progress of
Alzheimer's disease. To date, the only side effect experienced in clinical
studies that appeared to be associated with solanezumab treatment has been mild
chills consistent with an infusion reaction; other side effects reported in the
Phase II study include nausea, vomiting, headache, back pain, and cough. For a
more complete listing of potential side effects, prospective clinical trial
participants should refer to the informed consent document.
About Lilly Biotech Efforts
Lilly is the 5th largest biopharmaceutical company in the world, with
global biotech sales of more than $5.3 billion in 2008. Today, 40 percent of
Lilly’s drug pipeline ? and 50 percent of its late stage pipeline ? is
comprised of biotech compounds spanning potential treatment options for
diabetes, cancer, Alzheimer’s disease, osteoporosis, multiple sclerosis and
inflammation.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers ? through medicines and information
?for some of the world's most urgent medical needs. Additional information
about Lilly is available at www.lilly.com.
This press release contains forward-looking statements about the potential
of the investigational compound LY2062430 and reflects Lilly’s current beliefs.
However, as with any pharmaceutical product under development, there are
substantial risks and uncertainties in the process of development and
regulatory review. There is no guarantee that the product will receive
regulatory approvals, or that the regulatory approval will be for the
indication(s) anticipated by the company. There is also no guarantee that the
product will prove to be commercially successful. For further discussion of
these and other risks and uncertainties, see Lilly’s filing with the United
States Securities and Exchange Commission. Lilly undertakes no duty to update
forward-looking statements.
i. USAN (United States Adoptive Name council) adopted, INN (International
Non-proprietary Name) pending
ii. “2009 Alzheimer’s Disease Facts and Figures.” Alzheimer's Association.
Available at:
http://www.alz.org/national/documents/report_alzfactsfigures2009.pdf. May 13,
2009.
iii. Small, GW, Rabins, PV, Barry, PP, Buckholtz, NS, DeKosky, ST, Ferris,
SH, Finkel, SI, Gwyther, LP, Khachaturian, ZS, Lebowitz, BD, McRae, TD, Morris,
JC, Oakley, F, Schneider, LS, Streim, JE, Sunderland, T, Teri, LA, Tune, LE.
Diagnosis and Treatment of Alzheimer's Disease and Related Dis-orders:
Consensus Statement of the American Association for Geriatric Psy-chiatry, the
Alzheimer's Association, and the American Geriatrics Society. JAMA 1997; 278:
1363-1371.
iv. Wimo A., Winblad B., Jonsson L. An estimate of the total worldwide
societal costs of dementia in 2005 (2007) Alzheimer's and Dementia, 3 (2), pp.
81-91
P-LLY
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
SOURCE: Eli Lilly and Company
CONTACT: Jamaison Schuler for Lilly, APR, mobile, +1-317-847-9617
PHOTO: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
(LLY)
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