| HEPATITIS
C Drug
(SP - 30) |
Infectious Disease
Programs |
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SP-30: A NOVEL TREATMENT FOR HEPATITIS C
A
small molecule Benzamide derivative indicated as a
Hepatitis C (HCV) antiviral therapeutic.
| SP-30
Capabilities: |
- Inhibits
HCV replication preventing Hepatitis C from
entering healthy cells
- Presents
a favorable safety profile (observed to have
a selectivity index >32 in in-vitro studies)
- May
be administered as a stand-alone therapeutic
or in combination
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SP-30
Profile: In two (2) National Institutes
of Health (NIH) in-vitro studies, SP-30 showed a
96.3 % inhibition in preventing Hepatitis C from entering
healthy cells compared to injectable Alpha-Interferon’s
97% inhibition with reported low efficacy and numerous
side effects.
SP-30
Significance:
HCV is characterized by inflammation
of the liver, usually producing swelling and, in many
cases, permanent damage to liver tissues. HCV is one
of the most common types of viral hepatitis. It can
lead to long-term, persistent infections, chronic
liver disease, and in many cases, death. Liver failure
due to HCV is the leading cause of liver transplants
in the United States.
SP-30 Current
Treatments: To date, there are no
cures for HCV. Two forms of treatment are currently
administered and a third class is being considered
for approval into this $4 billion market (2004).
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SP-30
Advantage: SP-30 appears to be the first
true HCV antiviral therapeutic offered for treatment of
individuals infected with HCV. In addition to its efficacy,
SP-30 appears to have an extremely favorable safety profile,
can be administered as a stand-alone or combination therapy,
and may offer the convenience of oral dosing.
SP-30:
Antiviral Properties
SP-30 has demonstrated promise in preclinical studies as
an antiviral therapeutic in the treatment of Hepatitis C
(HCV) as well as a therapeutic adjuvant in the treatment
of HIV. SP-30 offers several distinctive competitive advantages
as a potential adjuvant therapeutic in the treatment of
HCV infected individuals. SP-30 is uniquely different from
other inhibitors of viral replication in that it appears
to condition the cell. This unique multiple target mechanism
of action provides several advantages.
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In HCV infected individuals, SP-30 uses its unique mechanism
to build a fence around the cell and prevent viral entry.
Consequently, HCV is unable to replicate or mutate and
is eventually eradicated by the immune system.
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Because
SP-30's targets belong to the host cell and not to the
virus itself, SP-30 may not be susceptible to the development
of resistance.
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SP-30
does not appear to be contraindicated with any other currently
approved ARV or HCV treatments.
Therefore,
based on its favorable in-vitro inhibition data, Samaritan
is developing a Phase I clinical study protocol for SP-30
as a potential adjuvant therapeutic in the treatment of
HCV infected individuals.
SP-30:
A NOVEL TREATMENT FOR HEPATITIS C
Hepatitis is a disease characterized by inflammation of
the liver, usually producing swelling and, in many cases,
permanent damage to liver tissues. Viral hepatitis refers
to a set of at least six viruses that are known to cause
hepatitis. Hepatitis C (HCV) is one of the most common types
of viral hepatitis and it can lead to long-term, persistent
infections, chronic liver disease, and in many cases, death.
In contrast to most other types of hepatitis, more than
80% of HCV infections become chronic and lead to liver disease.
Hepatitis C, in combination with hepatitis B, now accounts
for 75% of all cases of liver disease around the world.
Liver failure due to hepatitis C is the leading cause of
liver transplants in the United States.
It
is suspected that there are, at present, more than 4.5 million
people in the United States that are infected with the hepatitis
C virus (HCV), and more than 200 million around the world
- making it one of the greatest public health threats faced
in this century, and perhaps one of the greatest threats
to be faced in the next century. A vaccine against hepatitis
C may not be available for many years and there are already
many times more people infected with HCV as have HIV. Although
increased public awareness has led to a dramatic decrease
in the number of new cases of acute HCV (from 230,000 a
year in 1980 to 36,000 per year)i[i], without prompt intervention
to treat infected populations and prevent the spread of
disease, the death rate from hepatitis C will surpass that
from AIDS.
In addition SP-30 demonstrated a very low
toxicity profile in vitro.
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