Date: 2011-12-21
Type of
information: Treatment of the first patient
phase: 2a
Announcement: treatment of the first patient
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: colorectal cancer
Therapeutic
area: Cancer Oncology
Country: Canada
Trial
details:
- This Phase 2a clinical trial will enroll approximately 20 patients with colorectal cancer metastases to theliver. Patients will receive a single injection of JX594/TG6006 intravenously or intratumorally two weeks prior to surgical resection. Tumors will be evaluated for evidence of JX594/TG6006 replication andpathologic response. Patients will subsequently be followed for progression-free survival and overall survival.
Latest
news:
- Transgene and Jennerex have announced that the first patient has been treated in a Phase 2a clinical trial of JX594/TG6006 as a neoadjuvant therapy in patients who are undergoing surgery to treat colorectal cancer that has spread to the liver. The study is being led by Rebecca Auer, M.D., surgical oncologist at The Ottawa Hospital, associate scientist at the Ottawa Hospital Research Institute and assistant professor of surgery at the University of Ottawa in Ottawa, Canada. The clinical trial is being supported by funding from the Ontario Institute for Cancer Research.
Is
general: Yes
