Samaritan to Initiate Phase III Clinical Trial in Europe to Accelerate Development Timeline of Its HIV Oral Entry Inhibitor SP0
16 June 2006 - 12:09AM
Business Wire
Samaritan Pharmaceuticals Inc. (AMEX:LIV): -- Trial Designed to
Tackle HIV Drug Resistance (One or More of a Patient's Current HIV
Drug Regime Stops Working Leading to a Lack of Treatment Options)
-- Pre-clinical Studies Suggest SP01A Prevents HIV Virus Entry Into
Healthy Cells -- Human Clinical Studies Suggest SP01A's Inhibitory
Effect on the HIV Virus (10 Day Monotherapy study found 0.4 log10
difference between high dose and placebo control group.) Samaritan
Pharmaceuticals Inc. (AMEX:LIV) a developer of innovative drugs,
announced today, its subsidiary Samaritan Europe is accelerating
SP01A's, its lead HIV drug candidate, drug development timeline by
initiating a late-stage Phase III trial in Europe before the end of
its ongoing Phase II 28 day monotherapy study of SP-01A. This Phase
III clinical study will be a double-blind, placebo controlled
study, which will assess the safety and efficacy of SP01A on viral
load in HIV-positive treatment experienced patients. Dr. Greeson,
CEO of Samaritan Pharmaceuticals stated, "We believe there is a
critical need and urgency for new drugs to tackle drug resistance,
as the HIV virus mutates to render current drugs ineffective,
leaving patients without very many treatment options. SP01A appears
to have cytoprotective properties with a new mechanism of action.
In addition, since the drug works within the cellular membrane, and
not directly on the HIV virus, early preclinical studies, indicate
drug resistance does not seem to develop. We hope to accelerate and
confirm our previous studies in this large, well-controlled
clinical trial." HIV Phase III Clinical Study Highlights: -- The
study plans to enroll 411 patients (137 placebo and 274 active dose
group). -- For a total of 48 weeks, patients will be randomly
assigned to receive placebo or SP01A, the placebo group will
receive placebo, plus optimized background of approved
antiretroviral therapy; and the SP01A active dose group, will
receive 800 mg of SP01A (400 mg bid) plus optimized background of
approved antiretroviral therapy. -- The primary endpoint will be
the mean change in HIV RNA viral load (log10) after 24 weeks in the
active arm compared to the placebo arm. SP01A is currently being
studied in a Phase IIb stage 2 (28-day) monotherapy study. So far,
the study has enrolled 21 subjects out of the projected 62 and is
expected to conclude the study in October of this year. Samaritan
Pharmaceuticals: "We LIV....to Save Lives." Samaritan is a
small-cap Biotech, driven to discover, develop and commercialize
innovative therapeutics' to alleviate an individuals greatest
health fears, heart attacks, cancer, stroke, memory loss and AIDS.
Look at www.samaritanpharma.com. Please register on Website so we
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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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