Elan Corporation, and Wyeth-Ayerst Laboratories, announced they have decided not to resume further dosing of AN-1792, an experimental immunotherapeutic drug under development for the treatment of mild to moderate Alzheimer’s disease.
In early January, the exploratory Phase 2A study of AN-1792 was suspended immediately after learning that four patients in France were reported to have clinical signs consistent with inflammation in the central nervous system (CNS). Since halting dosing in January, eleven additional patients reported symptoms associated with CNS inflammation.
The researchers, in consultation with the independent Safety Monitoring Committee, have concluded that no additional patients shall be treated with AN-1792, but patients will continue to be followed to assess on-going safety. The companies are continuing their pre-clinical and clinical investigations into these cases and are in regular contact with regulatory agencies in the United States and Europe regarding the progress of this effort.
All patients who experienced brain inflammation, or are, receiving medical care and most have shown improvement or have recovered. The companies are aggressively collaborating with clinical investigators to better understand the cause of this phenomenon.
“We will continue to monitor all patients who have received drug in these studies,” says Dr. Ivan Lieberburg, Elan’s Chief Scientific and Medical Officer. “Our decision to first suspend dosing, and now permanently discontinue dosing in this exploratory phase of clinical research with this single compound, in our opinion, remains in the best interest of the health and safety of patients.”
AN-1792 represents the first in a series of therapeutic approaches currently under development that explore the clinical potential of immunotherapy for Alzheimer’s disease.
“These developments are not uncommon in early clinical research with an innovative compound like AN-1792,” says L. Patrick Gage, President, Wyeth-Ayerst Research.
Clinical trials with AN-1792 were being conducted in the US and four European countries in patients with Alzheimer’s disease using AN-1792 (also known as AIP-001). Approximately 360 patients had received multiple doses of AN-1792.
The Phase 2A study was designed to measure the immune response to immunization with the drug, as well as changes in other parameters in Alzheimer’s patients with mild to moderate disease. The results of this study were expected to provide additional information regarding the immune response to AN-1792, as well as valuable information useful for the design and evaluation of other therapeutic agents being studied in the collaborative development program.