Immune Response enrolls clinical trial for IR103
The Immune Response Corporation has enrolled the first patients at the Canadian site in its initial clinical trial investigating IR103, the company's newest product candidate in development for the treatment of HIV.
The Immune Response Corporation has enrolled the first patients 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.
'Our preclinical research has shown results that suggest the combination of our 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,' said Dr John Bonfiglio, chief executive officer of the company. '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.'
The two-part, nine-arm, randomised, 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.