Clinical Trials

Date: 2011-04-05

Type of information: Presentation of results at a congress

phase: 1-2

Announcement: results

Company: Transgene (France) Jennerex (USA)

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

Action mechanism:

• oncolytic virus/gene therapy/oncolytic immunotherapy. Pexa-Vec (pexastimogene devacirepvec) is an oncolytic immunotherapy that utilizes the vaccinia poxvirus strain as its backbone. This strain has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express the immunogenic GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack.
• Pexa-Vec is designed to attack cancer through three diverse mechanisms of action: 1) the lysis of cancer cells through viral replication, 2) the shutdown of the blood supply to tumors through vascular targeting and destruction, and 3) the stimulation of the body's immune response against cancer cells, i.e., active immunotherapy.

Disease: hepatocellular carcinoma

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news: Transgene and Jennerex have announced that new data from Phase 1 and 2 clinical studies of JX-594 were presented in an oral presentation at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) over the weekend at the Internationales Congress Centrum in Berlin, Germany. This presentation highlighted data from 35 patients with either primary liver cancer, known as hepatocellular carcinoma, or cancer metastases to the liver (including colorectal cancer, melanoma and renal cancer). All patients were given intratumoral injections (up to eight treatments) over the course of JX-594 therapy. Twenty-three patients (66%) exhibited significant tumor necrosis and responses by modified Choi criteria (decreased tumor density). Choi responses have also been documented in non-injected tumors, consistent with prior data on JX-594. Seven patients (20% of evaluable) also exhibited objective response by Response Evaluation Criteria in Solid Tumor (RECIST) criteria, including two complete responses upon long-term follow-up. Twenty patients (57%) had stable disease as defined by RECIST criteria.

Is general: Yes