Alzheimer’s Vaccine to Advance to Exploratory Phase Two Studies

The promising Alzheimer’s immunotherapy drug AN-1792 has completed the first phase of safety experiments and will soon enter into a second round of studies. This was according to a July 2001 announcement by the Elan Corporation and Wyeth-Ayerst Laboratories.

In the Phase 1 safety studies, the AN-1792 vaccine had been administered to more than 100 patients with mild to moderate Alzheimer’s disease in a variety of dosage regimens. The results obtained indicate that the vaccine is well tolerated and that a portion of patients developed a sufficient immunological response to AN-1792 to warrant the initiation of the additional study.

Elan and American Home Products Corporation plan to initiate a multicentre exploratory Phase 2A clinical study with approximately 375 patients with mild to moderate Alzheimer’s disease at sites in the US and Europe.

This study is designed to measure the immune response to the beta amyloid peptide and assess the impact on a range of cognitive, physiological, and biological markers of Alzheimer’s disease. Patients with mild to moderate Alzheimer’s disease will be enrolled and evaluated using conventional cognitive tests and by other surrogate measures.

These results produced verbal support from organizations such as the Alzheimer’s Association.

“The Alzheimer’s Association welcomes today’s news that the experimental drug AN-1792 appears to be well tolerated for human use, elicits an immune response in some patients, and is ready for Phase Two clinical trials,” said Bill Thies, Ph.D., Vice President of Medical and Scientific Affairs.

“For years, scientists have hypothesized that the presence of amyloid plaques causes cell death and leads to the decline in a person’s cognitive functions,” said Thies. “With this potential plaque-clearing drug, scientists now have an opportunity to test this theory and take a major step toward unlocking the mystery behind this devastating disease.”

It is expected this study will commence in the third quarter of 2001 and take approximately two years to complete. The interim and final results of this study are expected to provide additional information regarding AN-1792, as well as valuable information useful for the development of other therapeutic agents being studied as part of the collaborative development program.

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