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Samaritan to Initiate Phase III Clinical Trial in Europe to Accelerate Development Timeline of Its HIV Oral Entry Inhibitor SP01A

Posted on: Thursday, 15 June 2006, 12:00 CDT

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 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.

Source: Business Wire

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