Advocate Peggy Willocks was in the original Spheramine trial.
Ray
Spheramine®
Spheramine is a novel cell therapy product in development for the treatment
of Parkinson's disease, a neurodegenerative disorder that affects over four
million individuals world wide.
Parkinson's disease results from declining levels of dopamine production and
associated neuronal activity in specific regions of the brain. Symptoms
include tremor, rigidity, and slowness of normal voluntary movement. Current
treatments involve daily administration of oral agents containing dopamine
precursors or dopamine agonists which raise the levels of dopamine activity
in the brain. However, most patients eventually develop a "wearing-off
effect" where each dose alleviates symptoms for a shorter amount of time.
Because these therapies are orally delivered, they also result in elevated
systemic levels of dopamine, causing potential side effects.
Spheramine is an innovative, standardized cell therapy using normal human
cells. These cells, retinal pigment epithelial (RPE) cells, are placed on
microcarriers and injected into the brain to provide a localized continuous
source of dopamine in brain regions deficient in dopamine.
Titan is developing Spheramine in partnership with Bayer Schering Pharma AG
for the treatment of advanced Parkinson's disease. Spheramine utilizes
Titan's novel, cell-coated micro-carrier (CCMT) technology that enables
minimally-invasive, site specific delivery of therapeutics to the central
nervous system. CCM technology involves adhering cells to microscopic beads
that enable the survival of the cells in the central nervous system. CCM
technology also avoids the need for immunosuppression (suppression of the
immune system to prevent rejection.)
Positive results from a pilot clinical study to assess the safety and
preliminary efficacy of Spheramine in six subjects with moderately severe to
severe Parkinson's disease, demonstrated an average improvement in motor
function of 48% over baseline at one-year post treatment. Data was presented
at the International Congress on Parkinson's disease in June 2005
demonstrating continuing average improvement in motor function of 40% in
these patients, four years after treatment.
Based on the encouraging results from the pilot study, Titan and Bayer
Schering Pharma AG initiated a 68-patient, randomized, double blind,
controlled Phase IIb clinical study to further evaluate the safety and
efficacy of Spheramine. Enrollment in the study is complete with a total of
71 patients treated. Results from the study are expected to be available in
the third quarter of 2008.
The FDA has granted Fast Track designation for Spheramine. The FDA's Fast
Track Program is designed to facilitate the development and expedite the
review of drug candidates that demonstrate the potential to treat serious or
life-threatening diseases and address unmet medical needs. The FDA has also
approved Orphan Drug designation for Spheramine for the treatment of
advanced Parkinson's disease.
from Viartis Parkinson's Disease News site
Rayilyn Brown
Board Member AZNPF
Arizona Chapter National Parkinson's Foundation
rbrown@xxxxxxxxx
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