B-Cell Chronic Lymphocytic Leukemia Clinical Trial Initiated with Argos Therapeutics' AGS-005 Personalized Immunotherapy.

DURHAM, N.C. -- Argos Therapeutics today announced that dosing has been initiated in a Phase 1/2 clinical trial to test the activity and safety of AGS-005 in B-cell chronic lymphocytic leukemia (CLL). AGS-005 is a personalized dendritic cell-based immunotherapy, with optimized immune response characteristics, that is designed to stimulate the patient's immune system to target and destroy the patient's cancer cells.

"B-cell chronic lymphocytic leukemia is the most common adult leukemia in the Western hemisphere, yet there is no broadly applicable standard treatment with the promise to cure for this condition. Therefore, it is important to evaluate new treatment modalities designed to improve survival and quality of life for CLL patients," stated Dr. Graeme Fraser of McMaster University (Hamilton, Ontario), principle investigator and sponsor of the study. "CLL is well suited for a dendritic cell-based immunotherapy approach because tumor cells are readily available through a blood draw. This allows for exploitation of both known and unknown tumor antigens to stimulate immune responses. I feel that the use of Argos' RNA-loaded dendritic cell technology represents a potentially important development in CLL treatment."

"A Phase 1 study with a version of this product for the treatment of kidney cancer demonstrated immunopotency and a favorable safety profile; therefore, we look forward to the outcome of the Phase 1/2 trial in CLL," said Lothar H. Finke, M.D., Chief Medical Officer and Vice President of Regulatory Affairs for Argos. "Advancing into clinical trials in this second cancer indication is a significant achievement for Argos and demonstrates the applicability of our autologous dendritic cell-based immunotherapies to multiple indications."

About the AGS-005 Phase 1/2 Trial in CLL

Up to 22 patients with previously treated B-cell chronic lymphocytic leukemia will be enrolled in the Phase 1/2 trial. The primary objective of the trial is to measure patient-specific anti-tumor response of the AGS-005 immunotherapeutic following treatment with one low dose of intravenous cyclophosphamide. Secondary trial objectives include clinical response, safety assessments, measurement of additional immune induction profiles, and confirmation of the feasibility of large-scale production of AGS-005 in a timely manner.

The development of AGS-005 is part of Argos' broad collaboration covering dendritic cell-based immunotherapies with Kirin Brewery's Pharmaceutical Division. Costs associated with the Phase 1/2 trial in CLL are partially funded through a peer-reviewed grant from the Ontario Cancer Research Network.

RNA-loaded Dendritic Cell Technology

Argos's proprietary approach to personalized cancer immunotherapy is based on optimizing a patient's own (autologous) dendritic cells to trigger a tumor-specific immune response. To address the challenge of the unique genetic profile of each patient's cancer and the genetic mutations of that cancer, Argos loads the autologous dendritic cells with a patient's total tumor RNA. Through this process, dendritic cells are enabled to recognize the complete antigenic repertoire of a particular patient's tumor, resulting in an immunotherapy personalized for a patient's specific disease.

About Argos Therapeutics, Inc.

Argos Therapeutics is developing breakthrough immunotherapies that target the unique features of a patient's disease. This new generation of personalized cancer and infectious disease therapeutics trains the immune system to recognize and attack the disease. Argos' scientific leadership in RNA-loaded dendritic cells and advanced manufacturing processes provide a platform to tackle virtually all forms of cancers and infectious diseases. www.argostherapeutics.com

Argos is a private biotechnology company headquartered in Research Triangle Park, NC. The Company has clinical trial programs in cancer and human immunodeficiency virus (HIV) and has an ongoing co-development and commercialization alliance with the Pharmaceutical Division of Kirin Brewery Company , Limited.