Biotech Values

[DewDiligence]

Second-generation Alzheimer’s vaccine from Wyeth/Elan begins patient enrollment:

[According to ‘brcm2001’ on the ELN message board, this vaccine, called AAB-001, is one of the two Elan drug candidates for which Elan has engaged GTCB to produce founder goats. The other is known to be Antegren.]

http://www.pharmalive.com/News/index.cfm?articleid=148958&categoryid=21

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University of Pittsburgh Researchers to Test Investigational Treatment for Alzheimer's Disease

PITTSBURGH, June 24, 2004 /PRNewswire/ -- The Alzheimer's Disease Research Center (ADRC) at the University of Pittsburgh has been chosen as a research site to participate in the first human clinical trials of an investigational treatment for Alzheimer's disease (AD).

The investigational drug known as AAB-001, a specific antibody to beta-amyloid, is thought to work by removing a protein called beta-amyloid, which is present only in small amounts in the normal brain but is greatly increased in the brains of AD patients. Researchers believe the amyloid plaques result from unknown genetic and environmental miscues that cause the brain to produce and deposit it in clumps. The accumulation of amyloid plaque is believed to cause the death of neurons, in part by stimulating another abnormal protein metabolism known as neurofibriallary tangles in neurons, resulting in memory loss. As the disease progresses, more and more plaques accumulate and patients suffer greater cognitive impairments.

"Working with AAB-001 gives us an exciting opportunity to continue our Alzheimer's disease research," said Steven T. DeKosky, M.D., professor of neurology, psychiatry, neurobiology and human genetics at the University of Pittsburgh School of Medicine and director of the ADRC. "If the safety data from these initial clinical tests are positive, larger clinical trials may be initiated to determine whether AAB-001 can be a potential treatment breakthrough."

The drug, AAB-001, is the first of its kind to emerge for testing since trials of an anti-amyloid vaccine were suspended two years ago due to medical complications. [The “medical complications” were intracranial inflammation.] AAB-001 is a novel monoclonal antibody, using synthetically engineered antibodies directed to seek out and reduce amyloid. The monoclonal antibody is intended to provide the patient's immune system with the capability to respond to the amyloid, a key difference from the earlier vaccine strategy. In that study, the vaccine, AN-1792, stimulated the patient to mount their own immune response, that is, produce their own antibodies.

The primary purpose of this study is to evaluate the safety of AAB-001 and how well increasing doses of AAB-001 (in successive groups of subjects) are tolerated. A secondary purpose of the study is to measure the amount of AAB- 001 in the blood, and how long it remains in the blood over time.

AAB-001 is an investigational drug and is not currently approved for commercial use by the U.S. Food and Drug Administration. In this study, AAB- 001 is being given to humans for the first time. The study is sponsored by Wyeth Research, and is an initiative of the Elan/Wyeth Alzheimer's Immunotherapy Program.

The study has so far enrolled three patients in Pittsburgh and will eventually include approximately eight. Participants must meet criteria outlined in the study protocol.
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