Immune Response Corp drug to be studied in drug-naive HIV patients

This new arm will enroll HIV patients who have not yet begun highly active antiretroviral therapy (HAART) and who will receive IR103, Remune, or saline over 28 weeks. It will enroll at two sites in the UK and one site in Canada.

The study, originated in 2004, has already enrolled 45 HIV patients receiving HAART at three sites in Canada and UK. The primary objective of this study is to evaluate safety and bioactivity, or the ability to generate HIV-specific immune responses to IR103, in HIV patients with and without HAART. Ability to generate HIV-specific immune responses is thought to be an important indicator of clinical utility.

“We believe IR103 will demonstrate similar results to those we’ve seen in the Remune trials with drug-naive HIV patients, such as the one recently completed in Italy. Current guidelines recommend delaying HAART treatment in newly diagnosed HIV patients, in part because current treatments are so toxic,” said Dr John Bonfiglio, president and CEO of The Immune Response Corporation. “IR103 and Remune may fill this gap by providing an efficacious and safe therapy in these early stages of the disease.”

IR103 combines the company’s patented HIV-1 immunogen with Amplivax, an immunostimulatory oligonucleotide adjuvant. Amplivax was developed by Hybridon, and has been licensed to The Immune Response Corporation.