LAS VEGAS--(BUSINESS WIRE)--May 30, 2006--Samaritan Pharmaceuticals Inc. (AMEX:LIV - News): 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 - News) 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.
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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.
Contact: Samaritan Pharmaceuticals, Inc. Gene Boyle, 702-735-7001 GeneBoyle@SamaritanPharma.com
Source: Samaritan Pharmaceuticals, Inc.
