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Argos Therapeutics Secures $25 million Series D Financing to Commence Phase 3 ADAPT Study in Patients with Metastatic Renal Cell Carcinoma (mRCC) in Mid-2012
Date:4/24/2012

es the need for more effective treatments in metastatic RCC."

The FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs for the treatment of serious or life-threatening diseases with the potential to address unmet medical needs. Fast Track designation allows for the review timeline to be truncated to six months compared to the traditional 12 months.

The Phase 3 ADAPT study is a randomized, multicenter, open-label study of AGS-003 in combination with sunitinib compared to sunitinib plus placebo. Argos plans to enroll approximately 450 mRCC patients at approximately 100 clinical sites in North America and Europe. The primary endpoint for the ADAPT study is overall survival. Additional endpoints include overall response, immune response, progression-free survival and safety.

Regarding the Phase 2 clinical study, 21 patients with newly diagnosed metastatic clear cell RCC were enrolled. Treatment consisted of six-week cycles of sunitinib, four weeks on and two weeks off, plus AGS-003, which was administered as an intradermal injection every three weeks for five doses, and then every 12 weeks until progression in combination with sunitinib. Results presented during the 2012 ASCO Genitourinary Cancers Symposium indicated that the median progression-free survival in patients with newly diagnosed, unfavorable risk mRCC was 11.2 months and estimated Kaplan-Meier median overall survival was 29.3 months in this study, based upon follow-up through January 2012. In addition, AGS-003 was well tolerated in combination with sunitinib, with no immunotherapy related serious adverse events observed.   

About the Arcelis™ Technology

Arcelis is Argos's proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies. This platform is based on optimizing a patient´s own (autologous) dendritic cells to trigger a tumor- or pathogen-specific immune respon
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SOURCE Argos Therapeutics Inc.
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