[tt] Reversal Of Alzheimer's Symptoms Within Minutes In Human Study

[Hughes, James J.]

http://www.sciencedaily.com/releases/2008/01/080109091102.htm

Reversal Of Alzheimer's Symptoms Within Minutes In Human Study

ScienceDaily (Jan. 9, 2008) - An extraordinary new scientific study,
which for the first time documents marked improvement in Alzheimer's
disease within minutes of administration of a therapeutic molecule, has
just been published in the Journal of Neuroinflammation.

This new study highlights the importance of certain soluble proteins,
called cytokines, in Alzheimer's disease. The study focuses on one of
these cytokines, tumor necrosis factor-alpha(TNF), a critical component
of the brain's immune system. Normally, TNF finely regulates the
transmission of neural impulses in the brain. The authors hypothesized
that elevated levels of TNF in Alzheimer's disease interfere with this
regulation. To reduce elevated TNF, the authors gave patients an
injection of an anti-TNF therapeutic called etanercept. Excess TNF-alpha
has been documented in the cerebrospinal fluid of patients with
Alzheimer's.

The new study documents a dramatic and unprecedented therapeutic effect
in an Alzheimer's patient: improvement within minutes following delivery
of perispinal etanercept, which is etanercept given by injection in the
spine. Etanercept (trade name Enbrel) binds and inactivates excess TNF.
Etanercept is FDA approved to treat a number of immune-mediated
disorders and is used off label in the study.

The use of anti-TNF therapeutics as a new treatment choice for many
diseases, such as rheumatoid arthritis and potentially even Alzheimer's,
was recently chosen as one of the top 10 health stories of 2007 by the
Harvard Health Letter.

Similarly, the Neurotechnology Industry Organization has recently
selected new treatment targets revealed by neuroimmunology (such as
excess TNF) as one of the top 10 Neuroscience Trends of 2007. And the
Dana Alliance for Brain Initiatives has chosen the pilot study using
perispinal etanercept for Alzheimer's for inclusion and discussion in
their 2007 Progress Report on Brain Research.

The lead author of the study, Edward Tobinick M.D., is an assistant
clinical professor of medicine at the University of California, Los
Angeles and director of the Institute for Neurological Research, a
private medical group in Los Angeles. Hyman Gross, M.D., clinical
professor of neurology at the University of Southern California, was
co-author.

The study is accompanied by an extensive commentary by Sue Griffin,
Ph.D., director of research at the Donald W. Reynolds Institute on Aging
at the University of Arkansas for Medical Sciences (UAMS) in Little Rock
and at the Geriatric Research and Clinical Center at the VA Hospital in
Little Rock, who along with Robert Mrak, M.D., chairman of pathology at
University of Toledo Medical School, are editors-in-chief of the Journal
of Neuroinflammation.

Griffin and Mrak are pioneers in the field of neuroinflammation. Griffin
published a landmark study in 1989 describing the association of
cytokine overexpression in the brain and Alzheimer's disease. Her
research helped pave the way for the findings of the present study.
Griffin has recently been selected for membership in the Dana Alliance
for Brain Initiatives, a nonprofit organization of more than 200 leading
neuroscientists, including ten Nobel laureates.

"It is unprecedented that we can see cognitive and behavioral
improvement in a patient with established dementia within minutes of
therapeutic intervention," said Griffin. "It is imperative that the
medical and scientific communities immediately undertake to further
investigate and characterize the physiologic mechanisms involved. This
gives all of us in Alzheimer's research a tremendous new clue about new
avenues of research, which is so exciting and so needed in the field of
Alzheimer's. Even though this report predominantly discusses a single
patient, it is of significant scientific interest because of the
potential insight it may give into the processes involved in the brain
dysfunction of Alzheimer's."

While the article discusses one patient, many other patients with mild
to severe Alzheimer's received the treatment and all have shown
sustained and marked improvement.

The new study, entitled "Rapid cognitive improvement in Alzheimer's
disease following perispinal etanercept administration," and the
accompanying commentary, entitled "Perispinal etanercept: Potential as
an Alzheimer's therapeutic," are available on the Web site of the
Journal of Neuroinflammation
(http://www.jneuroinflammation.com/content/5/1/2/abstract).

Author Hyman Gross, M.D., has no competing interests. Author Edward
Tobinick, M.D. owns stock in Amgen, the manufacturer of etanercept, and
has multiple issued and pending patents assigned to TACT IP LLC that
describe the parenteral and perispinal use of etanercept for the
treatment of Alzheimer's disease and other neurological disorders,
including, but not limited to, U.S. patents 6015557, 6177077, 6419934,
6419944, 6537549, 6982089, 7214658 and Australian patent 758523.

Adapted from materials provided by University of Arkansas for Medical
Sciences.