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Argos Therapeutic Arcelis™ Immunotherapy AGS-003 in Combination With Sunitinib Shows Statistically Significant Correlation of Immune System Response to Overall Survival in Phase 2 Study in Patients with Advanced Renal Cell Carcinoma (RCC)
Date:1/31/2012

DURHAM, N.C., Jan. 31, 2012 /PRNewswire/ -- Argos Therapeutics Inc., today announced that it presented a high resolution immune monitoring analysis of AGS-003-006, a Phase 2 study of its Arcelis™ immunotherapy, AGS-003, in combination with sunitinib in patients with advanced renal cell carcinoma (RCC). The results showed a statistically significant correlation between anti-tumor memory T cell responses and overall survival. AGS-003 in combination with sunitinib overcame the immuno-suppressive environment of RCC and induced a tumor-specific multi-functional memory CTL response. The results were presented orally at the Global Technology Community's (GTC) 4th Immunotherapeutics and Immunomonitoring Conference in San Diego.

"We believe that the high resolution immune monitoring analysis of the Phase 2 study of AGS-003 and sunitinib represents the first time that pattern recognition algorithms originally developed for gene microarray datasets have been applied to an immunologic dataset to identify immune correlates to clinical outcome," said Charles Nicolette, Ph.D., Argos' chief scientific officer and vice president of research and development. "The multiparametric flow cytometry data from the study that we analyzed demonstrated that the combination of AGS-003 and sunitinib induced tumor-specific multi-functional memory CTL that were statistically significant correlates to overall survival in the study, thereby supporting the intended mechanism of action of AGS-003."

AGS-003-006 was an open label Phase 2 trial of AGS-003 in combination with sunitinib in patients with newly diagnosed, unfavorable-risk, metastatic clear cell RCC. AGS-003 was designed to stimulate the proliferation and multi-functionality of CTLs targeted directly to the autologous RCC tumor antigens.  In analyzing the data from the trial we sought to detect immune correlates by using multi-parametric flow cytometry to identify 16 unique RCC antigen reactive CTL subsets ba
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