Sexual HealthBoth 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) 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
http://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
US$150 billion(ii). In 2005, the total cost worldwide of dementia, of which
Alzheimer"s disease is the most common cause, was estimated at US$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.
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 here. 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
Disorders: Consensus Statement of the American Association for Geriatric
Psychiatry, 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
Eli Lilly and Company