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CORRECTING and REPLACING Reversal of Alzheimer's Cognitive Decline By New Treatment Suggested in Small Human Pilot Study; Peer Reviewed Study Published By Medscape General Medicine

Posted on: Friday, 28 April 2006, 12:00 CDT

Please replace the release with the following corrected version due to multiple revisions.

The corrected release reads:

REVERSAL OF ALZHEIMER'S COGNITIVE DECLINE BY NEW TREATMENT SUGGESTED IN SMALL HUMAN PILOT STUDY; PEER REVIEWED STUDY PUBLISHED BY MEDSCAPE GENERAL MEDICINE

Unprecedented results using a new way to treat Alzheimer's Disease(AD) were published this week in the neurology section of the peer-reviewed journal, Medscape General Medicine. The article presents the results of a six-month, open-label, uncontrolled pilot study in which 15 patients with Alzheimer's ranging in severity from mild to severe received weekly perispinal injections of etanercept, a medication designed to reduce excess levels of tumor necrosis factor (TNF). TNF is a molecule which initiates and amplifies the inflammatory response in the brain and other organ systems.

Dr. Edward Tobinick, Assistant Clinical Professor of Medicine, UCLA, was lead author of the study with co-authors Dr. Hyman Gross, Clinical Professor of Neurology at USC, Dr. Hart Cohen, Associate Clinical Professor of Neurology, UCLA, and Dr. Alan Weinberger, Associate Clinical Professor of Medicine/Rheumatology, UCLA. All of the physicians are in full-time private practice in West Los Angeles.

Dr. Gross noted, "So far this appears to be the most effective treatment for the reversal of some of the major symptoms of Alzheimer's disease. I have recommended that my patients continue on this treatment, as without it they continue to cognitively decline. Alzheimer's disease can be as devastating as any cancer and represents a global medical crisis. Large scale clinical trials should begin immediately to define its most appropriate therapeutic use."

The pilot study discussion includes in-depth analysis of how this innovative method of anti-TNF treatment may reduce inflammation in the Alzheimer's patient's brain. An increasing body of research points to inflammation as a critical factor in the pathophysiology of Alzheimer's. Previous work by Elizabeth Tarkowski and her colleagues at the University of Goteborg in Sweden documented levels of TNF 25 times elevated in the cerebrospinal fluid (the fluid surrounding the brain) in patients with AD.

Etanercept is FDA approved for treating rheumatoid arthritis and related conditions, but is off-label for treating AD(1). The new study suggests that perispinal etanercept may have the potential to improve cognition when added to standard therapy consisting of memantine and/or a cholinesterase inhibitor.

"There is an enormous unmet medical need in Alzheimer's disease, an incurable, terminal and devastating affliction for the patient, as well as for families and society in general," stated Dr. Cohen. "We should take these findings very seriously and confirm them in broader trials initiated immediately."

The full-study is available at www.medscape.com

Further information is available at www.nrimed.com.

(1) Dr. Tobinick has been awarded several U.S. patents describing this treatment method, including 6,982,089 and 6,177,077.

Source: Business Wire

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