Argos' Arcelis immunotherapy reduces viral load in interim analysis of Phase 2 HIV trial

Argos Therapeutics today announced that, in an interim analysis of a Phase 2 trial, its Arcelis immunotherapy targeted at HIV, AGS-004, demonstrated a significant reduction in viral load and a delay in viral rebound kinetics during a 12-week antiretroviral treatment interruption (ARTI) when compared to pre-ART viral loads. The data will be presented in an oral poster presentation session. ART represents a major breakthrough for the management of HIV-infected patients, but is not without side effects and is a life-long commitment. Therapeutic immunotherapies to enhance immune response and control viral replication are needed to limit exposure to ART.

Data from an analysis of 22 patients who have completed the 12 weeks ARTI in the ongoing, multicenter Phase 2 trial were presented by Jean-Pierre Routy, M.D., principal investigator of the study at the McGill University Health Centre in Montreal, at the International AIDS Conference (AIDS 2010) in Vienna, Austria. The mean reduction in viral load at week 12 of the ARTI for responders.

In a second poster presentation, Charles A. Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development for Argos, presented an analysis of immune responses induced by AGS-004 and their relationship to viral load control. The immune monitoring data demonstrated a correlation between the induction of effector memory CD8+ T cells and viral load control and underscored the importance of avoiding activation of CD4+ T cells, a unique property of AGS-004.  

"The updated results from this study demonstrate that AGS-004 is well tolerated, immunogenic, potentially efficacious and safe," said Dr. Routy. "We are encouraged that the upcoming, double-blind, placebo controlled, randomized Phase 2b study co-funded by the NIH may further show that this personalized immunotherapy is feasible for the treatment of HIV-1 infected patients."

Jeffrey Abbey, President and Chief Executive Officer of Argos, added, "Our unique and broadly applicable approach to personalized immunotherapy  has demonstrated the ability to produce measurable immune responses against HIV and forms of cancer, including renal cell carcinoma as demonstrated by recently presented data from a Phase 2 study of AGS-003. Coupled with the automation of our manufacturing process, we believe that our Arcelis platform can yield promising treatments for patients that can be complimentary adjuncts to current drug therapy."