Development of Immunogene Therapy for B-cell malignancy

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(1) Material Production and Safety IsuueWe have tested followeing examination on our product : Abnormal Toxicity, LAL Test for Endotoxin, Detection of Contaminating DNA, Rabbit Pyrogen Test, Sterility Assay. No abnoramal data was observed on our materials.(2) Developement of New Vaccine Vector.We have constructed a novel DNA expression vector based on Semliki Forest virus (SFV) . A recombinant cDNA genome of SFV, in which the SFV structural genes were replaced by a polylinker cassette to allow for insertion of heterologous DNA, was placed under the control of a cytomegalovirus immediate-early enhancer/promoter with a polyadenylation signal. Transfection of mammalian cells with this SFV-based plasmid vector, pSFV3-CMV-lacZ-pA, resulted in transient high-level expression of a beta-galactosidase reporter gene.(3) Preparation for Clinical Trail.We have collected over hundred smples of leukemia patients for the vaccine production. Protocol for idiotype vaccination including Informed Consent and basic data was prepared for publish.