Rapid Dissemination followed by Spontaneous Regression of Metastatic Hepatocellular Carcinoma after Liver Radiofrequency Thermal Ablation: A Case Report with Correlative Immune Assay.

Rapid intrahepatic and distant metastasis of hepatocellular carcinoma (HCC) after locoregional treatment for early stage tumor is very rare. Descriptions of spontaneous regression of HCC exist in case reports, but its true mechanism is unclear. Here, we describe a case of rapid dissemination with lung metastasis shortly after localized RFA treatment of HCC liver lesions, followed by spontaneous, sustained regression of those lung lesions.

Anti-drug Antibody Sample Testing and Reporting Harmonization.

A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of immunogenicity findings and expedient review by industry and health authorities. To address these key bioanalytical reporting gaps and provide a report structure for documenting immunogenicity results, this cross-industry group was formed to establish harmonized recommendations and a develop a submission template to facilitate agency filings. Provided here are recommendations for reporting clinical anti-drug antibody (ADA) assay results using ligand-binding assay technologies.

Safety and Immunogenicity of M2-Deficient, Single Replication, Live Influenza Vaccine (M2SR) in Adults.

M2SR (M2-deficient single replication) is an investigational live intranasal vaccine that protects against multiple influenza A subtypes in influenza-naïve and previously infected ferrets. We conducted a phase 1, first-in-human, randomized, dose-escalation, placebo-controlled study of M2SR safety and immunogenicity. Adult subjects received a single intranasal administration with either placebo or one of three M2SR dose levels (10, 10 or 10 tissue culture infectious dose (TCID)) expressing hemagglutinin and neuraminidase from A/Brisbane/10/2007 (H3N2) (24 subjects per group).