AIDSWEEKLY Plus; Monday, July 21, 2003
Staff Medical Writers

Patients in this study treated with IMMUNITIN (HE2000), the company's lead investigational compound for infectious disease, experienced a statistically significant reduction in the total number of all opportunistic infections (OIs) over the 13-month study period when compared to patients receiving placebo.

There were 25 evaluable patients in the study who were dosed once a day with either IMMUNITIN or placebo for 5 days and then observed for 5 weeks before receiving an additional 5-day treatment course.

This schedule was repeated for up to a total of seven courses and patients were monitored for approximately 400 days.

Over this treatment course, patients in the placebo group experienced 67% more opportunistic infections than those treated with IMMUNITIN (p=0.03). Patients treated with IMMUNITIN also experienced a statistical trend towards reduced circulating C - reactive protein (CRP) compared to placebo-treated patients (p=0.10). C - reactive protein is a well-known marker for inflammation.

Published reports in the medical literature indicate inflammation is closely associated with disease progression in HIV/AIDS. IMMUNITIN therapy was generally well-tolerated in this study, with transient pain and inflammation at the injection site being the most common drug related adverse event. The study was a feasibility study to aid in the design of a larger study powered to show statistical differences in delaying time to opportunistic infections in HIV patients.

"This result is what you would hope to see from an immune therapy for AIDS patients," stated Dr. James Frincke, chief scientific officer for Hollis-Eden. "In addition, it's exciting to see a statistically significant result in late stage patients where opportunistic infections are expected. We believe this is the first time an immune modulator has shown significant benefit against a hard clinical endpoint like the cumulative number of opportunistic infections in late-stage AIDS patients."

This article was prepared by AIDS Weekly editors from staff and other reports.

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