Date: 2012-03-20
Type of
information: Treatment of the first patient
phase: 1-2
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: metastatic colorectal cancer
Therapeutic
area: Cancer Oncology
Country: USA, Canada, Europe
Trial
details:
- The two-arm, dose-escalation study will evaluate JX594/TG6006 as a monotherapy and in combination with irinotecan. The multicenter study is conducted in the United States, Canada and Europe and is designed to enroll up to 42 patients. Patients will be enrolled in consecutive dose-escalation cohorts testing two types of administration of JX594/TG6006: either JX594/TG6006 as a monotherapy or JX594/TG6006 in combination with standard dose irinotecan. Patients in both groups will receive five weekly intravenous infusions of JX594/TG6006 followed, at the investigator’s option, by up to three intratumoral injections or JX594/TG6006 into metastases to the liver. The combination group will receive concomitant administrations of irinotecan. Once the maximum tolerated dose is determined for each treatment group, additional patients will be enrolled at that dose level. The endpoints of the trial include safety, dose optimization, and tumor responses as measured by RECIST and Choi criteria.
Latest
news:
- Transgene and Jennerex have announced that the first patient has been treated in a Phase 1/2 clinical trial of JX594 in patients with whose metastatic colorectal cancer has become refractory to chemotherapy and who are either refractory to or ineligible for a treatment with cetuximab.
The two partners have recently initiated enrollment and randomization of patients in a Phase IIb clinical trial called TRAVERSE. The trial is evaluating the use of JX594/TG6006 to treat patients with hepatocellular carcinoma.
Is
general: Yes
