The Immune Response Corporation has initiated a new arm of a Phase I/II clinical trial investigating IR103, the Company's newest product candidate for the treatment of HIV.
This new arm will enrol HIV patients who have not yet begun highly active antiretroviral therapy (HAART) and who will receive IR103, Remune, or saline over 28 weeks. The new drug-naïve arm will enrol at two sites in the United Kingdom and one site in Canada. The study, originated in 2004, has already enrolled 45 HIV patients receiving HAART at the three sites in Canada and Britain.
"We believe IR103 will demonstrate similar results to those we've seen in the Remune trials with drug-naïve 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 John N. Bonfiglio, president and CEO of The Immune Response Corporation.
The randomized, single-blind, controlled, multi-centre Phase I/II study began in 2004 and will follow patients for 28 weeks. 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, release from the company said here.
IR103 combines the Company's patented HIV-1 immunogen with Amplivax, an immunostimulatory oligonucleotide adjuvant. Amplivax was developed by Hybridon, Inc. and has been licensed to The Immune Response Corporation.