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.
Source:
Biospace, “Trizell
ltd. announces phase 3 pivotal study of interferon alfa-2b gene therapy in
malignant pleural mesothelioma,” (March 20, 2019). [Link]