Date: 2016-05-19
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Amgen (USA - CA)
Product: talimogene laherparepvec
Action
mechanism: oncolytic virus/immunotherapy product. Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. The rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.
Disease: breast cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The purpose of this phase 1-2 study is to determine if an oncolytic virus called talimogene laherparepvec injected directly into the tumor during chemotherapy prior to surgery can enhance the elimination of triple negative breast cancer tumors. The natural herpes simplex 1 virus typically causes cold sores around the mouth, but the talimogene laherparepvec version of the herpes virus has been changed to prevent it from reproducing in normal tissue. However, it can still attack and break open cancer tissue which is why it is used as a treatment for cancer. It is thought that this virus can also help recruit the participant's immune system to attack the cancer cells during their treatment and possibly destroy the tumor tissue more effectively than chemotherapy alone. (NCT02779855)
Latest
news: * On May 19, 2016, a Phase I trial sponsored by Amgen was published on the NIH website ClinicalTrials.gov for talimogene laherparepvec.
