A Phase III clinical trial is now underway in the pivotal study of interferon alfa-2b gene therapy in pleural mesothelioma. After promising results from the Phase II clinical trial, scientists and researchers are hopeful they are just one step away from FDA approval for this cancer treatment that is over 20 years in the making. Europe-based gene therapy company Trizell, is sponsoring the trial.
This study involves TR002 – which is a gene therapy drug, used in an immunotherapy setting. The goal of gene therapy is to get at the root cause of a disease. Since genes hold the instructions for making proteins and other building blocks necessary for cell function, if a gene’s instructions are incorrect or missing, the “ingredients” for a healthy cell and person may be lacking. Instead of dealing with the errant effects of faulty genes after the fact, gene therapy attempts to deliver the proper instructions to cells, avoiding the negative affects altogether. Immunotherapy treatments attempt to work with the body’s own immune system, repairing it so the body can fight off cancer naturally, and without all the negative side effects associated with other traditional cancer treatments.
TR002 is a modified virus that triggers the production of interferon, a protein that kills cancer cells. Since it is genetically engineered, it is unable to reproduce like a virus does, but is still able to provide the protein necessary for terminating cancer cells. This treatment will be used in combination with chemotherapy. Phase II trials used the standard chemotherapy treatment pemetrexed , but this study will use gemcitabine chemotherapy.
This Phase III trial will look at 300 patients across the United States, Canada, Russia, UK and Australia. TR002 will be administered one time by catheter directly to the pleural cavity. Two weeks later, the patient will then begin rounds of gemcitabine chemotherapy. This trial has already begun at The University of Toledo Eleanor Dana Cancer Center in Ohio. The New York University School of Medicine, the University of Pennsylvania are next to follow. In the end, over 50 locations worldwide are to begin the trial this month. This Phase III trial is especially for mesothelioma patients whose standard treatment has stopped working.
The promising results from the Phase II trial showed an 87.5 percent disease control rate and an average survival rate of 17 months and have scientists and researchers hopeful for even better results with the Phase III trial.
Phase III trials compare promising new drugs or procedures with the current standard treatment. Large numbers of people from across the nation usually participate in Phase III trials and receive either the new treatment or the standard treatment. In order to be sure the study results are accurate, trial participants in all phases must fit a certain profile. Eligibility for mesothelioma trials are often specific as to age, how long it has been since therapy, stage of disease, and other characteristics. To find our more information, visit our Clinical Trails page.
Biospace, “Trizell ltd. announces phase 3 pivotal study of interferon alfa-2b gene therapy in malignant pleural mesothelioma,” (March 20, 2019). [Link]