Methods: Four groups of C57B1/6 HFD fed mice were orally

treated daily for 22 weeks with BY-2 cells expressing PRX-106, equivalent to 0.5μg (1X) or 10μg (20X), for groups A and B, respectively. Mice in control groups C and D were treated with the same orally administered volumes of BY-2(-) plant cells, or saline. The immune modulatory effect of PRX-106 was determined by serum liver enzymes X-396 in vivo and triglycerides levels, liver histology and intrahe-patic and systemic FACS analysis for Tregs and NKT cells. Results: Oral administration of BY-2 cells expressing PRX-106 is biologically active in the gut exerting a systemic immune modulatory effect and alleviating the liver disease. Intrahepatic NKT cells increased to 2.83% and 3.58% in treated mice

in groups A and B, respectively, (p=0.01 for group B vs. control). A positive trend was noted for the intrahepatic/intrasplenic CD4+CD25+FoxP3+ Tregs ratio that decreased to 0.3 and 0.25 in groups A and B, respectively, along with alteration of the CD4/CD8 lymphocyte distribution. The immune modulatory effects were associated with alleviation of several disease parameters. Serum triglycerides levels decreased significantly to 186 and 124 mg/dL as compared with 214 and 260 mg/ dL in control groups (p <0.02 for both treated CHIR99021 groups vs. controls). A positive trend was noted for hepatic triglyceride content that decreased to 26.65 mg in group B, as compared with 32.61 and 32.5 in control groups C and D; and for serum AST levels that decreased to 370 and

296 u/L, respectively, in mice from groups A and B, as compared with 454 and 496 u/L, for untreated controls in groups C and D. Conclusions: Oral administration of plant cells expressing recombinant anti-TNF fusion protein shows biological activity, and exerts an immune modulatory effect alleviating the liver damage in the HFD model. The data suggests that it may serve as a novel and effective mode for oral immune therapy for NASH. Disclosures: Yoseph Shaaltiel – Employment: Protalix biotherapeutics Sveta Gingis-Velitski – Employment: protalix Einat Almon – selleck chemical Employment: Protalix David Aviezer – Management Position: Protalix ; Speaking and Teaching: Bar Ilan U. ; Stock Shareholder: Protalix Yaron Ilan – Board Membership: Exalenz, Plantylight; Consulting: Immuron, Protalix, ENZO, Abbott, Taxon, Teva The following people have nothing to disclose: Yehudit Shabat, Ami Ben Ya’acov Background: The production is free radicals are part of normal host defenses against infectious diseases. The generation of ROS in the respiratory burst is mediated by the multi-component mitochondrion enzyme, NADPH oxidase. Natural Killer (NK) cell impairment leads to fibrosis progression; accompanied with NLG4 over expressions in human Nonalcoholic-Fatty-Liver-Disease (NAFLD) and animal models of liver injury.