Argos Therapeutics' Phase 3 ADAPT Study for AGS-003 Highlighted During 11th Annual International Kidney Cancer Symposium
Approximately 70 North American Sites Are in Process and Enrollment Will Commence During Fourth Quarter 2012
DURHAM, N.C., Oct. 8, 2012 (GLOBE NEWSWIRE) -- Argos Therapeutics Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced that the ADAPT study was highlighted in a presentation delivered by Robert Figlin, MD, FACP, during the 11th International Kidney Cancer Symposium in Chicago, Ill. The presentation focused on experimental immunotherapy and vaccine strategies during which Dr. Figlin reviewed the ongoing Phase 3 ADAPT study and progress to date.
Argos Therapeutics, which also exhibited at the Symposium, is currently evaluating AGS-003, an investigational fully personalized, cancer immunotherapy, in the ADAPT pivotal phase 3 clinical trial for the treatment of stage IV kidney cancer, also known as metastatic renal cell carcinoma (mRCC).
Jeff Abbey, President and CEO of Argos Therapeutics, said, "The Kidney Cancer Association has made remarkable efforts to enhance the treatment and care of patients living with kidney cancer, as well as highlight the importance of participation in clinical trials to further educate the patient community about emerging therapies such as AGS-003. We are honored to have the support of the KCA and look forward to continued collaboration with key constituents of the kidney cancer community, as we continue to advance this novel personalized immunotherapy through clinical and regulatory processes."
In previous clinical trials, AGS-003 has been shown to trigger a patient-specific immune response in mRCC and treatment with AGS-003 has been associated with longer survival than expected, particularly in patients with an aggressive form of the disease. Even with current targeted therapies, patients with unfavorable prognosis (intermediate or poor risk disease) have an expected median survival of less than two years.
AGS-003 is being investigated, under an approved Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA), in combination with well-established targeted drug therapies in a clinical trial called ADAPT (The Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma). The study is expected to enroll 450 newly diagnosed mRCC patients. Approximately 70 North American sites are currently in process and enrollment will commence during the fourth quarter of 2012. If the study results are positive, AGS-003 will be considered for approval by the FDA and could be available to mRCC patients as soon as 2016.
About the Arcelis™ Technology
Arcelis is a fully personalized, active immunotherapy technology that captures all antigens, including mutated and variant antigens that are specific to each patient´s disease. It has been shown to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that are associated with toxicity. The technology can be leveraged to manufacture personalized therapies for any cancer or infectious disease.
The Arcelis process integrates readily into many current treatment paradigms by using only a small tumor or blood sample and the patient´s own dendritic cells, which are derived and then optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient sample to program the dendritic cells to target the entire disease-antigen repertoire. The activated, antigen-loaded dendritic cells are then formulated into the patient´s plasma and administered as an injection into the skin to produce the desired patient-specific immune response.
Arcelis technology also overcomes many of the manufacturing and commercialization challenges that have impeded other cancer immunotherapies. Automated processes allow a single facility to serve all of North America and can be used to treat any cancer or infectious disease with the same manufacturing process and equipment.
About Argos Therapeutics
Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform. Argos´ most advanced product candidate AGS-003 has initiated a Phase 3 study for the treatment of mRCC, and the Company plans to have top line data from its Phase 2b study of AGS-004 for the treatment of HIV in the second half of 2013. Argos also recently completed a successful Phase 1a study of AGS-009 in patients with lupus.
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