Jennerex, Inc. announced Phase 2 clinical data of JX-594, delivered intravenously and subsequently through an intra-tumoral route, demonstrating safety as well as disease control and tumor responses in patients with hepatocellular carcinoma (HCC). 

Twenty five Asian patients with advanced HCC, 20 of whom were refractory to sorafenib (Nexavar; Bayer and Onyx), were treated with an initial intravenous dose of JX-594, and the majority of patients then received sequential intratumoral doses of JX-594 at Week One and Week Three. The majority of patients subsequently received treatment with sorafenib.

Following treatment with JX-594 alone at four weeks, 62% of patients had disease control as measured by modified RECIST.  Tumor biopsies of four patients following intravenous infusion showed four of four patients had local infection of JX-594 in tumor tissue while normal liver tissue was not affected.  Furthermore, after six or 12 weeks, 59% of patients had disease control as measured by modified RECIST and 75% of patients had objective responses by Choi criteria. Eighty-five percent of patients had disease control by mRECIST and/or Choi response. 

JX-594 is an engineered oncolytic immunotherapy designed to selectively target and destroy cancer cells through three mechanisms of action: 1) the lysis of cancer cells 2) the stimulation of an immune response against cancer cells, (ie, active immunotherapy), and 3) the shutdown of the blood supply to tumors. JX-594 takes advantage of the natural attributes of poxviruses and was engineered to target and destroy solid tumors both systemically and locally. The strain naturally targets cancer cells due to common genetic abnormalities in cancer cells. JX-594 was engineered to enhance this cancer-selectivity by inactivating its thymidine kinase (TK) gene and encode the immunogenic GM-CSF gene, to enhance the immune response against cancer cells.

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