NorthWest Biotherapeutics Inc (NWBO)

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The following tertiary endpoints can provide evidence to support the primary
endpoint....

....ENDPOINT: Immunostimulatory response (yes or no). A patient will be
considered a responder if one of the following conditions holds at least one time
point in the study: a) T cell proliferative response to DCVax-L shows a stimulation
index of 2 or greater, b) a greater than 3-fold increase in CD8+ cells staining with
tumor antigen tetramers. -- RK citing old DCVax-L Phase III protocol

Vaccination with tumor lysate-pulsed dendritic cells was safe, and no evidence of autoimmune disease was noted. Ten patients were tested for the development of cytotoxicity through a quanti- tative PCR-based assay. Five of ten patients demonstrated robust systemic cytotoxicity as demonstrated by IFN- release by PBMC in response to tumor lysate after vaccination. Using HLA restricted tetramer staining, we identified a significant expansion in CD8+ antigen-specific T-cell clones following DC vaccination in 4 patients, all of whom also demonstrated strong post- treatment antitumor cytotoxicity, as determined by qPCR measurement of IFN message in restimulated PBMC. -- 2004, (Yu, Wheeler) Study IM-20. VACCINATION OF PATIENTS WITH MALIGNANT GLIOMA WITH TUMOR LYSATE-PULSED DENDRITIC CELLS ELICITS ANTIGEN-SPECIFIC CYTOTOXICITY