The Immune Response Corporation, a biopharmaceutical company involved in immune-based therapy for HIV and multiple sclerosis, announced the first patients have been enrolled at the Canadian site in its initial clinical trial investigating IR103, the Company's newest product candidate in development for the treatment of HIV.
This trial, with active sites in the United Kingdom and Canada, will represent the first human experience with IR103, which combines the Company's patented HIV-1 Immunogen with Amplivax, an immunostimulatory oligonucleotide adjuvant.
The two-part, nine-arm, randomized, single-blind, controlled, multi-centre phase I/II study began this summer and will run for approximately 28 weeks with 80 patients enrolled. The primary objective of this study is to evaluate safety and bioactivity or the ability to generate HIV-specific immune responses to IR103, with or without Incomplete Freund's Adjuvant (IFA), in HIV patients on HAART (highly active anti-retroviral therapy). Ability to generate HIV-1 specific immune responses is thought to be an important indicator of clinical utility, the company release says.
"Our preclinical research has shown results that suggest the combination of HIV-1 Immunogen with Amplivax in IR103 elicits a strong immune response. We believe this type of response will be replicated in human subjects by IR103. We are delighted to advance IR103 into its first clinical study formally initiating a development plan designed to carefully examine this important product candidate," John N. Bonfiglio, CEO of The Immune Response Corporation said adding, "Further, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has cleared our protocol and we plan to be enrolling patients in the UK shortly."
Amplivax was developed by Hybridon, Inc and has been licensed to The Immune Response Corporation.
The Immune Response Corporation is a biopharmaceutical company dedicated to becoming a leading immune-based therapy (IBT) company in HIV and multiple sclerosis (MS). Remune, currently in Phase II clinical trials, is being developed as a first-line treatment for people with early-stage HIV. The Company has initiated development of a new IBT, IR103, which incorporates a second-generation immunostimulatory oligonucleotide adjuvant.