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Samaritan Kicks Off Second HIV Phase II Monotherapy Trial to Further Study Oral HIV Entry Inhibitor Drug SP-01A

Posted on: Tuesday, 3 January 2006, 06:00 CST

Samaritan Pharmaceuticals Inc. (AMEX:LIV):

Decision to Advance SP-01A Starts Off With:

-- Extensive Preclinicals

-- A PIb/IIa 29-Patient ARA Study

-- And Concluding PIIb 10-Day Monotherapy

Samaritan Pharmaceuticals Inc. (AMEX:LIV), a developer of innovative drugs, announced today it is conducting a second Phase IIb monotherapy trial to further study the effects of SP-01A for 28 days. This 28-day monotherapy study will allow Samaritan to gain longer-term data on SP-01A as an oral entry inhibitor and possible candidate to treat HIV drug resistance patients.

SP-01A In-Vitro Preclinicals

-- Demonstrated efficacy comparable to currently approved anti-HIV drugs;

-- Observed to have minimal toxic effect on human cells; and

-- Demonstrated significant in-vitro efficacy in preventing virus replication of HIV virus strains that may become resistant to currently approved anti-HIV treatments.

FDA Phase I/II

This SP-01A Phase Ib/IIa, eight-week, open-label study with subjects infected with HIV-1, and treated with concomitant triple combination, antiretroviral therapy, was a safety and dose response study conducted at the AIDS Research Alliance, Hollywood, Calif. SP-01A appeared to lower the amount of HIV virus in blood significantly, was well tolerated, had a favorable safety profile and improved quality of life.

http://www.samaritanpharma.com/html/hivspo1a.html

FDA Phase II, 10-Day Monotherapy Trial (32 patients) Concluding Stage

Phase IIb double-blind, placebo-controlled, multidose, 10-day monotherapy study in 32 treatment-experienced HIV patients to assess SP-01A's safety and effect on viral load, in HIV-1 positive individuals with evidence of increasing viral load, despite treatment with antiretroviral therapy.

FDA Phase II, 28-Day Monotherapy Trial (60 patients) Initiating

This study of SP-01A's efficacy is a Phase IIb double-blind, placebo-controlled, multidose, 28-day monotherapy study in 60 treatment-experience HIV patients to assess SP-01A's safety and effect on viral load, in HIV-1 positive individuals with evidence of increasing viral load, despite treatment with antiretroviral therapy.

HIV 28-Day Monotherapy Clinical Trial Highlights:

-- The study will enroll 60 evaluable patients total (4 dose groups with 15 evaluable patients per dose group).

-- The treatment groups are placebo, 200mg SP-01A daily, 400mg SP-01A daily, 800mg SP-01A daily.

-- The study is expected to start shortly and finish enrollment in about four months.

-- There is a two-week washout period followed by 28 days of monotherapy treatment and a two-week observation period.

-- The primary analysis for the study is the reduction in viral load (log10) within each of the four arms, as measured from Baseline to Day 28.

-- Expect initial draft study results to be available mid-year 2006.

Dr. Greeson, CEO of Samaritan Pharmaceuticals, stated, "This is another important milestone in the future development of SP-01A as a promising life-saving drug for HIV patients who are experiencing drug resistance. We believe this additional data will provide us important, and clinically relevant, data to demonstrate SP-01A's efficacy."

Samaritan Pharmaceuticals: "We LIV....to Save Lives."

Samaritan Pharmaceuticals is a drug development company driven to discover, develop and commercialize innovative therapeutics for AIDS, Alzheimer's, cancer and heart disease. Samaritan, in collaboration with Georgetown University, is advancing eight promising compounds out of its rich pipeline of 250 possible drug candidates, all of which have the potential to create revenue-generating opportunities. Additional information is at www.samaritanpharma.com.

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 Web site. 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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