Samaritan Achieves Concluding Stages of 10-Day HIV Monotherapy Trial
Posted on: Friday, 16 December 2005, 06:00 CST
Samaritan Pharmaceuticals Inc. (AMEX:LIV):
-- Pre-clinical and Clinical Studies Suggest SP-01A Prevents HIV Virus from Entering Human Cell
-- "Drug Resistance" is the Most Common Cause of Treatment Failure with Current Antiretroviral Therapy Regimes
-- With Encouraging Clinical Data SP-01A Could Be Life Saving Solution for HIV "Drug Resistant" Patients Running Out of Treatment Options
Samaritan Pharmaceuticals Inc. (AMEX:LIV) a developer of innovative drugs, announced today it has nearly completed enrollment in its Phase II double-blind, placebo controlled, multi-dose, 10-Day Monotherapy study. The trial assessed the safety and effect of Monotherapy with SP01A, on viral load in HIV- positive individuals with evidence of increasing viral load, despite treatment with other antiretroviral therapy.
Dr. Greeson, CEO of Samaritan Pharmaceuticals stated, "We are very excited about nearing the conclusion of this trial. Finding the patients was the most difficult but that was expected. I don't know what we would have done without CROfessionals, they have gone way above and beyond to do everything they can to expedite this trial and it wasn't easy." Dr. Greeson further stated, "We now feel completely optimistic about SP-01A moving forward and conducting additional studies to further explore the clinical antiviral activity of SP01A."
HIV 10-Day Monotherapy Clinical Trial Highlights:
-- Thirty-Two (32) evaluable patients total (four dose groups with eight evaluable patients per dose group).
-- The treatment groups consisted of placebo, 200mg SP01A daily, 400mg SP01A daily, 800mg SP01A daily.
-- There was a 4-week washout period followed by 10 days of Monotherapy treatment and a 2-week observation period.
-- The primary analysis for the study is the reduction of viral load (log10) within each of the four arms, as measured from Baseline to Day 10.
-- Expect to finish study shortly.
-- Expect initial draft study results to submit to the FDA to be available in the first quarter 2006.
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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