Caprospinol
(SP-233) Value: Caprospinol not only protects
the memory from future impairment but it has demonstrated
memory restoring
capabilities. Further, the ability of Caprospinol to stop
and eliminate amyloid plaque formation
suggests it may be the first major breakthrough in the actual
treatment of AD.
Caprospinol
(SP-233) Overview:
Caprospinol
(SP-233) is a novel Alzheimer's drug candidate that Samaritan
believes has the potential to clear beta-amyloid plaques from
the brain; a problem that most researchers today believe, is
the cause of Alzheimer's. Samaritan filed an IND application
for Caprospinol on October 30, 2006 and was subsequently granted
an IND number by the FDA. Samaritan believes that Caprospinol
could be a significant breakthrough in the treatment of Alzheimer's,
Samaritan plans to provide the information requested by the
FDA as quickly as possible, in order to continue moving our
Caprospinol development program forward. On
December 7, 2006, Samaritan announced that the U.S. Food and
Drug Administration (FDA) has completed its regulatory review
of our IND (Investigational New Drug) application for Caprospinol
and has requested that additional information be submitted
in support of the safety of Caprospinol, prior to initiating
Samaritan's proposed Phase I clinical study. Currently, Samaritan
has entered into a service agreement with Advinus Therapeutics
Ltd, India to provide the additional studies requested by
the FDA.
Treating
the Disease, not just the Symptoms
Unlike
drugs currently used to treat Alzheimer's that just alleviate
symptoms, Caprospinol might potentially be a viable treatment
for the disease itself. Preclinical studies have shown that
Caprospinol targets and binds to the beta-amyloid protein,
washing out beta-amyloid plaque from the brain. Today, the
beta-amyloid protein is what most researchers believe is the
cause of Alzheimer's disease.
SP-233
Mechanism Of Action
Two mechanisms of action have been identified to explain the
neuroprotective properties of Caprospinol against the beta-amyloid
peptide Ab1-42:
1. Caprospinol
binds to Ab1-42 and blocks its oligomerization into the highly
neurotoxic species Amyloid Derived Diffusible Ligands (ADDLs).
These anti-aggregation properties might also explain the ability
of Caprospinol to wash-out the amyloid plaques form rat brain
in vivo, in an animal model of Alzheimer's disease. Caprospinol
binding to Ab1-42 also blocks the peptide from entering the
mitochondria, one of its sites of toxin action, thus protecting
mitochondrial function in an indirect manner.
2. The
neuroprotective properties of Caprospinol could also be the
result of a direct pharmacological effect on the compound
on mitochondria. Caprospinol protects complexes IV and V of
the respiratory chain, exerts an anti-uncoupling effect and
inhibits the opening of the mitochondria transition pore.
In summary,
Caprospinol pharmacology includes binding to Ab1-42 and a
direct effect at the mitochondria level.
Samaritan
has mainly focused on the use of SP-233 for treatment of Alzheimer's
disease, however Samaritan believes that SP-233 would be useful
for the treatment of the neurological disorder, Parkinson's
disease.
- Parkinson's
disease (PD) affects both men and women in almost equal
numbers. Today, 1.5 million Americans have PD, and each
year 60,000 new cases are diagnosed. While PD usually develops
after age 65, 15% of those diagnosed are under age 50.
- The
typical early-stage annual medical cost per PD patient ranges
from $2,000 to $7,000. As the disease progresses, substantial
disability (inability to maintain balance, walk, speak,
move) requires assisted living and nursing home care, which
can exceed $100,000 per patient annually. Overall, PD is
estimated to cost the nation about $25 billion annually.
Source: "Older Americans, 2005 Survey"
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