Samaritan Reports Positive Preliminary Results with ''Oral'' HIV Entry Inhibitor in Phase II 10-Day HIV Monotherapy Trial
30 Mai 2006 - 2:59PM
Business Wire
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.
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