The Thymus Regeneration, Immunorestoration, and Insulin Mitigation (TRIIM) clinical trial was formally launched at a kickoff event in Northern California on October 1-2, 2015. The aim of the study is to demonstrate thymus regeneration in 10 healthy 50-65 year-old men, and in the process to preliminarily define and refine the specific methodologies needed for optimal thymus regeneration. The trial is one year in duration, with magnetic resonance imaging of the thymus before and after the one year course of treatment to demonstrate and quantify thymic morphological regeneration. In addition, detailed immunological and physiological tests will be used to evaluate the success of the trial. Baseline blood samples were collected for later analysis on October 1st and 2nd, and baseline thymus scans were completed on October 2nd. Treatment with study medications then began on October 7th.
The trial involves two cohorts, the second of which is expected to begin treatment in February of 2016. As a result, the trial as a whole is expected to conclude in 2017. The trial is being conducted with the help of several collaborators at Stanford University.
A major objective of the trial is to not only demonstrate reconstitution of thymic structure and function, with restoration of the production of new T cells, but to also do so using methods that have minimal toxicity. So far, three months into the trial for the first cohort, we are seeing little toxicity, and no concerning risk factor responses, which we believe is due to the unique methodology we are applying. We are also learning a great deal about other aspects of the human physiological response to our trial protocol, including a number of things that bode well for the application of our treatment to many aspects of aging beyond the prevention of immune system aging.
Our trial may be the first FDA-approved clinical trial that specifically targets a core aspect of human aging, being approved and launched prior to the well-publicized and also path-breaking TAME study of Dr. Nir Barzilai, which aims to show anti-aging benefits of metformin.
So far, we are excited by the progress we have been able to make, and we are looking forward to the completion of this, our company’s first clinical trial, which we believe could be the beginning of some remarkably beneficial advances in human medicine.
Note: We are conducting our trial on a very low budget. This means that some potentially interesting tests cannot be run because they are presently beyond our financial reach. If you would like to contribute to the scope and power of the TRIIM trial, please send us a contribution for this project. All of us at Intervene Immune are carrying out this trial pro bono, so 100% of your contribution will be spent on improving the knowledge we will be able to derive from this effort, which might allow us to help more people in the future — and conceivably, someday, maybe even you!