Immune Response begins trial

IMNR and partner Agouron (La Jolla, Calif.), a subsidiary of Warner-Lambert (WLA), began a Phase III trial of IMNR's Remune HIV-1 immunogen to treat HIV infection and AIDS using a surrogate end point instead of clinical end points, with which the product has previously not shown significant Phase III efficacy. The 472-patient U.S. Phase III trial will assess the durability of viral load suppression when Remune is added to current antiretroviral treatment regimens in patients who have achieved less than 500 copies/mL of HIV-1 RNA and greater than 300 CD4 T cells/mm3. The 96-week, adjuvant controlled trial will have a primary end point of delay in time to virologic relapse, defined as a predetermined plasma level of HIV-1 RNA. An interim analysis will be conducted after 48 weeks. ...