Immune Response initiates HIV treatment

The Immune Response Corporation has initiated a preclinical development program with IR103, a new vaccine candidate for the prevention and treatment of HIV.

The program is based on the promising results obtained from proof-of-concept studies with IR103, and is designed to provide data that would support regulatory filings for Phase I clinical studies. IR103 combines Amplivax, an adjuvant being developed by Hybridon to enhance the immune response to a vaccine antigen, with the HIV-1 Immunogen technology employed in Remune, an immune-based therapeutic vaccine currently being evaluated in Phase II clinical trials by The Immune Response Corporation for the treatment of HIV infected individuals.

'We are very pleased to be moving forward with the IR103 development program,' said Dr Georgia Theofan, vice president of clinical development at The Immune Response Corporation. 'IR103 demonstrated significant HIV- specific cell mediated immune responses in early preclinical studies. These data confirm initial results indicating that the combination of our vaccine antigen and immunomodulatory adjuvants such as Amplivax can have a strong effect on the overall immune response. Based on these results, we believe that the new IR103 vaccine candidate could have broad prophylactic and therapeutic applications that would complement our activities with Remune.'

'IR103 is composed of two agents, the HIV-1 Immunogen from The Immune Response Corporation, and Amplivax, a second generation CpG DNA immunostimulatory adjuvant that we recently licensed from Hybridon,' noted Dr John N. Bonfiglio, chief executive officer of The Immune Response Corporation. 'Both agents are currently in human clinical trials as stand alone therapeutics. Having safety data from human studies for each of the components should facilitate the clinical development of the combined product candidate. We are eager to complete the IR103 preclinical development program as quickly as possible with the goal of starting a Phase I clinical study during the first half of 2004. The Company's recent success at fund raising will allow us to initiate and complete this program according to our plan.'