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Samaritan Pharmaceuticals Inc. (AMEX:LIV):
-- Data Shows 0.4 log10 Difference Between the High-Dose and the
Placebo Control Group
-- Dose dependent relationship in the number of subjects who had
a reduction in viral load with the high dose group showing the
most difference as compared to placebo (55% SP-01A vs. 0%
placebo)
Samaritan Pharmaceuticals Inc. (AMEX:LIV) a developer of
innovative drugs, announced today, its preliminary results showing
antiviral activity in only 10 days with its Phase II 10-Day
Monotherapy study where SP-01A, an oral entry inhibitor, was tested
"alone" in patients experiencing HIV drug resistance.
The study, a Phase II double-blind, placebo controlled, multi-dose
study in treatment-experience HIV patients, assessed SP01A's safety
and effect on viral load in HIV-1 positive individuals, with evidence
of increasing viral load, despite treatment with antiretroviral
therapy.
In the preliminary finding, SP-01A was found to have a 0.4 log10
difference between the high dose group (800mg/day) and the placebo
control group. In addition, there was a dose dependent relationship in
the number of subjects who had a reduction in viral load with the high
dose group (800mg/day) showing the most difference as compared to
placebo (55% vs. 0%, respectively).
Dr. Greeson, CEO of Samaritan Pharmaceuticals stated, "Clinically
SP-01A has always been tested in concert with other antiretroviral
drugs, this is the first time it was tested alone. We are very
encouraged with the results and look forward to developing SP-01A to
hopefully be the first orally administered entry cell inhibitor drug
with a 'firewall' mechanism of action." Dr. Greeson went on to say,
"We started our Phase II 28-day monotherapy study and we are
continuing to enroll patients. Hopefully, the second stage study will
confirm the 10-day and possibly be more encouraging since we believe
SP-01A takes a little time to work."
HIV 10-day Monotherapy Clinical Trial Highlights:
The study enrolled 32 evaluable patients in four SP-01A daily dose
groups of placebo, 200mg, 400mg, and 800mg. Mean change in viral load
for the placebo and active arms, as measured from baseline to Day 11,
showed an increase of 0.4 log10 copies/ml for the placebo group, 0.1
log10 copies/ml for the 200mg/day dose group, 0.1 log10 copies/ml for
the 400mg/day dose group, and no change for the 800mg/day copies/ml.
The percentage of subjects having a reduction in viral load over the
10 day monotherapy treatment period were 0% for the Placebo group, 14%
for the 200mg/day group, 25% for the 400mg/day group, and 55% for the
800mg/day group.
Samaritan Pharmaceuticals: "We LIV....to Save Lives."
Samaritan is a small-cap Biotech, driven to discover, develop and
commercialize innovative therapeutics' for AIDS, Alzheimer's, Cancer
and Heart disease patients. Look at www.samaritanpharma.com. Please
register on Website so we can notify you of upcoming conference calls,
news and events.
Disclaimer
The company disclaims any information that is created by an
outside party and endorses only information that is communicated by
its press releases, filings and Website. This news release contains
forward-looking statements that reflect management's current beliefs
about the potential for its drug candidates, science and technology.
However, as with any biopharmaceutical under development, there are
significant risks and uncertainties in the process of development and
regulatory review. There are no guarantees that products will prove to
be commercially successful. For additional information about the
factors that affect the company's business, please read the company's
latest Form 10-K filed April 15, 2005. The company undertakes no duty
to update forward-looking statements.