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Argos Therapeutics Announces Globalization of Pivotal Phase 3 ADAPT Study for Personalized Cancer Immunotherapy

More Than 80 Sites Activated and Sites Initiating in Israel, Spain, and Czech Republic

Durham, NC- September 24, 2013 — 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 it has expanded its ADAPT Phase 3 clinical study for AGS-003 beyond North America to include sites in Israel, Spain and Czech Republic. To date, more than 80 sites have been activated and more than 100 patients have been screened globally.

“The continued expansion of the ADAPT study to key centers in Europe and Israel demonstrates the increasing excitement and support throughout the international community in advancing cancer immunotherapy research,” said Doug Plessinger, VP of Clinical and Medical Affairs of Argos Therapeutics. “This progress ensures we will remain on track to complete enrollment of the trial in the second half of 2014. Furthermore, we expect to activate more European sites in the United Kingdom and Italy, as well as 15-20 more in North America later this year.”

The Phase 3 ADAPT clinical study is evaluating AGS-003, an investigational, fully personalized immunotherapy being examined in combination with standard targeted drug therapy to determine its potential to extend the overall survival in newly-diagnosed, unfavorable risk metastatic renal cell carcinoma (mRCC) patients. Secondary endpoints in this study include progression-free survival, safety, overall response and immune response. The ADAPT study is a randomized, multicenter, open-label clinical trial expected to enroll 450 patients in approximately 120 sites, mostly in North America, under an approved Special Protocol Assessment by the Food and Drug Administration.

For more information about AGS-003 and the ADAPT study, visit www.ADAPTkidneycancer.com or follow us on Twitter at @ADAPTkdnycancer.

About the Arcelis™ Technology Platform
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, using only a small tumor or blood sample and the patient´s own dendritic cells, which are derived and 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 intradermal injection to produce the desired patient-specific immune response.

Arcelis technology also overcomes many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. A single manufacturing facility can serve all of North America and automated processes have been developed for cost-effective and scalable commercial manufacturing.

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 pivotal Phase 3 study for the treatment of mRCC, and the Company plans to have data from its Phase 2b study of AGS-004 for the treatment of HIV in the first half of 2014. For more information about Argos Therapeutics, visit www.argostherapeutics.com.

Source: Argos Therapeutics


The Ruth Group
Aaron Estrada (media)
[email protected]
(646) 536-7028

Stephanie Carrington (investors)
[email protected]
(646) 536-7017

Argos Therapeutics
Jeff Abbey (partners)
[email protected]
(919) 287-6308

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