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Thanks Peg! What would I, or I should say we, do without you.

Greg


Peggy Willocks <[log in to unmask]> wrote:
Greg W

I appreciated all of your promising comments about PD research. I, too,
feel like we truly are "5-10" years away from a cure. It just takes so
doggone long to get a treatment approved! (That's why we both volunteer
through the patient-dominated PD Pipeline Project - and we need more help -
see www.pdpipeline.org ,if interested.



I wanted to make a correction about the Spheramine clinical trials. . . They
are not yet in Phase III; they are still in Phase II, recruiting around 8
more people to complete the 68 needed for the double-blind study. (See
www.pdtrials.org or
http://www.clinicaltrials.gov/ct/show/NCT00059007?order=1



The results to be released by 2006 is the final reporting on the original 6
volunteers after 5 years. I was one of the 6 and am covinced I wouldn't be
walking, driving, and maintaining a pretty active life without having had
the surgery. The original 6 had the transplanting of retinal cells into our
brains (substantia nigra) one side only, to produce dopamine. These cells
came from a donated eye with one eye potentially able to treat thousands of
patients. Even if something happens in the latter phases of te trial, the
technology used (CCM - cell-coated microcarrier) for trasplanting the cells
will no doubt be applicable for other delivery system operations. The CCM
method encapsulates the donor cells with a gell-like substace, making
immunosuspression therapy not necessary as there have been no rejections
from the participants. And Phase II volunteers have had transplants on
BOTH sides of the brain during the procedure .

(For the Spheramine history, see
www.titanpharm.com/products/spheramine_product.html.



This report was part of a recent financial update on Titan Pharmaceuticals,
NJ:



Spheramine is a novel cell therapy product in development for the
treatment of Parkinson's disease. Enrollment in a randomized, controlled,
blinded, multi-center Phase IIb clinical study of Spheramine in advanced
Parkinson's disease is continuing. We estimate that initial results from
this
study will be available in the second half of 2006. Our corporate partner
for
the development of Spheramine, Schering AG, Germany, is funding this study.
In 2004, the U.S. Food and Drug Administration granted Fast Track
designation
for Spheramine for the treatment of Parkinson's disease.
In June 2005, Schering AG sponsored a symposium on Spheramine at the
International Congress on Parkinson's Disease and Related Disorders in
Berlin.
In the keynote address, Ray Watts, M.D., Professor and Chairman, Department
of
Neurology, University of Alabama Birmingham, presented 48-month follow-up
data
for the six patients in our pilot clinical study of Spheramine. The data
presented indicate that Spheramine is well tolerated and that patients
demonstrated 43% average improvement in motor function, four years after
treatment.

The final 5-year post check-ups of the original 6 volunteers in Phase I are
now being conducted. That is the report we will receive later in 2006. It
certainly sounds promising!



The following comes from the Germany-based website:



For this reason, we are investigating a new therapy approach in cooperation
with the US company Titan Pharmaceuticals: human epithelial cells from the
retina, which produce dopamine at their original site in the eye. These are
applied to microscopically small gelatine particles and subsequently
implanted in the brain of the patient. There they can emit dopamine locally,
rather like "intelligent bioreactors". Variations in dopamine level, which
are responsible for complications in therapy, are avoided as only that
amount of dopamine is released which is needed by the patient at the time,
stimulated by messenger substances in the brain. The efficacy of this
approach is being investigated in a study which is currently running.



See the Schering site
(www.schering.de/scripts/en/30_rd/areas/neuro/parkin.php) , for additional
info.



Peggy

Celebrate Life!




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