Date: 2012-07-25
Type of
information: Treatment of the first patient
phase: 2b
Announcement: treatment of the first patient
Company: Transgene (France) Jennerex (USA)
Product: JX594/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: South Korea, USA, Europe
Trial
details:
- The new Phase 2 trial is a multinational, single-arm, open-label study of JX594/TG6006 administered weekly by intravenous infusions in sorafenib-naïve patients with advanced hepatocellular carcinoma. The primary objective of the study is to determine the radiographic response rate based on modified RECIST and modified Choi criteria. Patients will subsequently be followed for progression-free survival and overall survival. The trial is being conducted at sites in South Korea, the United States, and Europe.
Latest
news:
- Jennerex Biotherapeutics, a private clinical-stage biotherapeutics company focused on the design, development and commercialization of first-in-class targeted oncolytic products for cancer, and Transgene have announced that the first patient has been treated in a Phase 2 clinical trial of intravenous treatment with JX594/TG6006 for patients with advanced hepatocellular carcinoma (HCC), or liver cancer, who have not received treatment with sorafenib—the current standard of care for this patient population.
This trial expands the clinical program of JX594/TG6006 in HCC, which is currently being evaluated in a multi-national Phase 2b trial (TRAVERSE NCT01387555 ) in patients with advanced HCC who have failed prior sorafenib.
Is
general: Yes
