Argos Therapeutics To Present Progress Update On Adapt Phase 3 Trial With AGS-003 At 2014 Genitourinary Cancers Symposium
DURHAM, N.C., Jan. 28, 2014 /PRNewswire/ — 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(TM) technology platform, today announced that the company will present a trial-in-progress update on the company’s ongoing pivotal phase 3 clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC). The update will be presented in a poster presentation entitled “ADAPT: An Ongoing International Phase III Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS 003) Plus Standard Treatment in Advanced Renal Cell Carcinoma (RCC)” on Saturday, February 1, 2014, at 6:45 AM during General Poster Session C at the Genitourinary Cancers Symposium being held in San Francisco.
The ADAPT study is a randomized, multicenter, open-label clinical trial designed to evaluate AGS-003, an investigational, fully personalized immunotherapy, in combination with standard targeted drug therapy, to determine the potential to extend overall survival in newly-diagnosed, intermediate and poor risk mRCC patients. Secondary endpoints in this study include progression-free survival, safety, overall response and immune response. The ADAPT trial is expected to enroll 450 patients in approximately 140 sites in North America, Europe, and Israel under an approved Special Protocol Assessment by the U.S. Food & Drug Administration. As previously announced, Argos remains on track to complete enrollment in the ADAPT trial by the end of 2014.
“With more than 110 sites now active, we are continuing to make great progress in advancing the ADAPT phase 3 trial, and anticipate reaching full enrollment by the end of this year. This patient-specific immunotherapy, combined with targeted drug therapy, has the potential to support improvements in overall survival for these newly diagnosed, intermediate and poor risk mRCC patients, for whom the survival rate is currently only 14-16 months, on average, with approved targeted therapies,” said Robert Figlin, director of the Division of Hematology/Oncology at Cedars-Sinai and co-lead principal investigator for the ADAPT trial.
To create AGS-003, ribonucleic acid (RNA) is isolated from a small tumor sample obtained from standard tumor removal surgery (nephrectomy). The patient’s dendritic cells are obtained from a single leukapheresis procedure. The tumor RNA is used to “program” these further optimized dendritic cells with the entire disease-antigen repertoire to trigger an immune response against the patient´s specific cancer. These antigen-loaded dendritic cells are then formulated into a simple, ready-to-use, intradermal injection.
“In the ADAPT trial, a small tumor sample obtained from routine nephrectomy followed by a single, standard leukapheresis collection are obtained from each patient through simple procedures which support streamlined enrollment. In the overall trial experience to date, AGS-003 has been readily integrated into standard surgical and medical treatment for participating metastatic RCC patients, which has helped to build significant enthusiasm among investigators, as well as the broader oncology research and clinical communities supporting this important research effort,” said Christopher Wood, professor and deputy chairman, Douglas E. Johnson, M.D. Professorship, Department of Urology, MD Anderson Cancer Center.
About the Arcelis(TM) Technology Platform
Arcelis is a fully personalized immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers and infectious diseases and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized immunotherapies.
The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are collected and optimized following a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease antigens. The activated, antigen-loaded dendritic cells are then formulated into the patient’s plasma and administered via intradermal injection.
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(TM) technology platform. Argos´ most advanced product candidate, AGS-003, has initiated a pivotal Phase 3 study for the treatment of mRCC, and the Company recently completed enrollment of its Phase 2b study of AGS-004 for the treatment of HIV. For more information about Argos Therapeutics, visit www.argostherapeutics.com.
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SOURCE Argos Therapeutics Inc.