Clinical Trials

Date: 2011-04-06

Type of information: Interim results

phase: 1

Announcement: results

Company: Transgene (France) Jennerex (USA)

Product: JX-594/TG6006 (Pexa-Vec)

Action mechanism:

oncolytic virus/gene therapy/oncolytic immunotherapy. This engineered oncolytic virus is designed to attack cancer through three diverse mechanisms of action: the lysis of cancer cells through viral replication, the ablation of the blood supply to tumors through vascular targeting and destruction, and the stimulation of the body's immune response against cancer cells (ie active immunotherapy).

Disease: refractory solid tumors

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Twenty three patients were enrolled in the Phase 1 dose-escalation clinical study using intravenous JX-594 to treat advanced, treatment refractory solid tumors. Tumor biopsies, evaluated through immunohistochemical analysis, showed that JX-594 given intravenously infected the vasculature of tumors causing the blood supply to the tumor to be disrupted. In addition, in another trial of patients with primary liver cancer who received intratumoral injections of JX-594, magnetic resonance imaging was used to assess for acute reduction in tumor perfusion.

Latest news:

Jennerex and Transgene reported interim results from Phase 1 dose-escalation clinical trials demonstrating that administration of JX-594 targets tumor vasculature. By directly targeting and replicating within tumor vasculature, JX-594 disrupts the blood supply to the solid tumors contributing to destruction of the cancer. Data were reported in a poster presentation at the 102nd Annual Meeting of the American Association for Cancer Research (AACR) in Orlando, Florida. Within just five days following treatment with JX-594, a significant decrease in tumor perfusion was observed resulting in acute tumor destruction. Vascular shutdown was restricted to tumor tissue, and no significant changes in perfusion were noted in normal tissue. At later timepoints, Choi (necrotic) responses were reported in these same patients.