Argos Therapeutics announced that it has initiated dosing of patients in a phase I clinical trial of its monoclonal antibody-based therapy, AGS-009, for the treatment of Systemic Lupus Erythematosus (SLE). AGS-009 is a humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with the ability to bind and neutralize human interferon alpha (IFN-a).

This phase I a trial is a double-blind, placebo-controlled, single dose escalation study in patients with mild to moderate SLE with six planned single dose levels. For each cohort of the single dose intravenous administration, three subjects will be randomized to receive AGS-009 and one subject will receive placebo. Each subject will be administered a single dose level of AGS-009 or placebo and then monitored continuously for safety, pharmacokinetics, pharmaco-dynamics and preliminary indications of bioactivity for 12 weeks. The primary endpoint for safety and tolerability will be dose-limiting toxicities, which will be evaluated to determine further progression of the trial through escalating single dose levels.

“Entering the clinic in a third indication is a major milestone for Argos,” said Jeff Abbey, president and chief executive officer of Argos. “In addition to testing our Arcelis RNA-loaded, dendritic cell-based immunotherapy for renal cell carcinoma and HIV in advanced clinical studies we have leveraged our expertise in the biology of dendritic cells to develop additional novel technologies with applications for lupus and other inflammatory disorders. There is a significant unmet medical need for the effective treatment of lupus, and AGS-009 may address this need.”

A total of 24 patients are expected to be enrolled at six sites in North America. The Phase 1 trial was begun by Novo Nordisk which subsequently returned the rights to the development of AGS-009 to Argos, the original developer of the antibody. Argos is currently dosing the fourth cohort of patients in this Phase 1 study. In February 2005, Argos received a $1 million grant from the Alliance for Lupus Research to develop AGS-009.

Arcelis is Argos proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies for HIV, other infectious diseases, and cancer. This platform is based on optimizing a patients own (autologous) dendritic cells to trigger a pathogen- or tumour-specific immune response. To address the challenge of the unique genetic profile of each patients disease and the genetic mutations of that disease, Argos loads the autologous dendritic cells with a sample of messenger RNA (“mRNA”) isolated from their disease. Through this process, dendritic cells can potentially prime immune responses to the entire antigenic repertoire, resulting in an immunotherapeutic that is customized to the patients specific disease.

Argos is an immunotherapy company developing new treatments for cancer, infectious and autoimmune diseases, and transplantation rejection. The company has generated multiple platform technologies and a diverse pipeline of products based on its expertise in the biology of dendritic cells — the master switch that turns the immune system on or off.