February 10, 2011
The Immune Tolerance Network (ITN) today announced enrollment of the first patient in a phase II clinical trial evaluating the efficacy and safety of abatacept in adult patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis. The trial aims to enroll 123 eligible participants at 20 clinical research centers across the United States over the next two years.
The clinical trial, called ACCLAIM (A Cooperative Clinical Study of Abatacept in Multiple Sclerosis), is being conducted through the ITN, an international consortium supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Additional partners in the trial include the National Institute of Neurological Disorders and Stroke, also a component of NIH. Bristol-Myers Squibb is providing the abatacept clinical supplies for the study.
“The ITN’s goal is to establish new treatments by developing a better understanding of the mechanisms of immune function and disease pathogenesis and advancing these discoveries into clinical practice”, said Jerry Nepom, MD, director of the ITN. “We need more therapy options for RRMS patients, and clinical trials like ACCLAIM are crucial to obtaining this goal.”
Multiple sclerosis (MS) is a chronic and progressive disease of the central nervous system that causes inflammation and destruction of the protective layer that surrounds the body's nerve fibers. This damage may result in cognitive impairment, physical disability and fatigue. According to the National MS Society, the disease affects about 400,000 people in the United States. Approximately 85 percent of these individuals have RRMS, a condition characterized by defined worsening of current symptoms followed by periods of partial or complete recovery or remission.
“The MS research community continues to look for new ways to improve treatment for patients with MS,” said Syed Rizvi, MD, head of the MS group at the Neurology Foundation in Providence, RI, and ACCLAIM investigator who enrolled the first participant. “We hope that this clinical trial of abatacept might eventually improve treatment by delaying or stopping the rate of MS progression.”
Abatacept (Orencia®; Bristol-Myers Squibb Company) is a biologic drug that selectively modulates the body’s immune system. Abatacept is approved by the U.S. Food and Drug Administration for the treatment of moderate-to-severe rheumatoid arthritis in adults and the treatment of moderate-to-severe polyarticular juvenile idiopathic arthritis in children aged 6 years and older. See www.Orencia.com for full prescribing information for abatacept. Clinical studies of abatacept are currently being conducted to determine whether it has a benefit in certain other autoimmune conditions.
ACCLAIM is a follow-up trial to an earlier ITN-led open label phase I trial that was not conducted with abatacept but examined CTLA4IgG4m, a similar protein that blocks/reduces activation of T cells and helps regulate the immune system. Samia J. Khoury, MD, a neurologist and co-director of the Partners MS Center at Brigham and Women’s Hospital in Boston, directed this trial. Dr. Khoury also is the principal investigator of the ACCLAIM trial.
Results from the phase I trial showed that "CTLA4IgG4m was well tolerated and prevented or reduced T cell activation in MS." The data suggested that it may be a promising approach to modifying the inflammatory process associated with MS. Results from the ITN-led study were published in the September 16, 2008, issue of Neurology.
"We were pleased with the encouraging safety and immunologic results of the phase I trial of CTLA4IgG4m in MS subjects," said Dr. Khoury. "We’re extremely excited to see the phase II ACCLAIM trial open and enroll the first participant.”
ACCLAIM is a clinical research trial to evaluate the safety and effectiveness of abatacept in individuals aged 18 to 65 years old who have been diagnosed with RRMS. The objective is to test whether abatacept can stop or delay the progression of the disease by targeting specific cells in the immune system, known as T cells, which are key players in the autoimmune attack that leads to disability. A number of other
drugs available for MS target the entire immune system, whereas abatacept targets specific T cells, therefore, researchers hope it will be an effective treatment for MS with an acceptable safety profile.
In the first part of the ACCLAIM trial, all participants will receive eight intravenous treatments over a period of six months. The treatments will be either abatacept or placebo. If a participant remains eligible, he or she will enter the second period of the trial and will receive another eight treatments over a six month period, but with the opposite treatment (abatacept or placebo) that was given in the first period.
Thus, all participants in the ACCLAIM trial will have the opportunity to receive abatacept if they remain eligible during the trial. There will be regular appointments that will include a total of 11 MRI procedures, physical and neurological exams, blood tests and motor function assessments. Participants will be asked to return for a follow-up visit three months after all treatments have been completed.
More information on the trial and participating clinical research centers can be found at www.acclaimstudy.org or clinicaltrials.gov. The following clinical research sites are either open for enrollment or soon will be:
The ITN is an international research consortium funded by the National Institute of Allergy and Infectious Diseases and the Juvenile Diabetes Research Foundation International. The ITN develops and conducts clinical studies of immune tolerance therapies — highly targeted treatments designed to prevent diseasecausing immune responses, without compromising the natural protective properties of the immune system. The ITN is a shared endeavor of three institutions: University of California, San Francisco; Benaroya Research Institute at Virginia Mason, Seattle; and Beth Israel Deaconess Medical Center, Boston. For more information about the ITN, visit www.immunetolerance.org
Contact:
ITNCommunications@immunetolerance.org
Immune Tolerance Network
Office of the Director
1201 Ninth Avenue, IN-RC
Seattle, WA 98101-2795
P: 206-341-0688
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