When Cortene contacted BHC with an idea, and an early draft protocol designed to test CT38 as a treatment for ME/CFS, Dr. Suzanne Vernon and I agreed to help them refine the protocol and
conduct the trial. The Cortene-funded trial was an FDA and IRB-approved protocol, and BHC carried out the protocol with detailed precision. We had a routine contract with Cortene to carry out the trial. It was challenging, because CT38 is a novel substance that has previously been tested only in healthy controls, as there is no animal model for ME/CFS.
Cortene has a vision that CT38 will be curative for people with ME/CFS based on the known mechanisms and their hypotheses. Before CT38 was tested in ME/CFS, I had no clinical data to form an opinion about efficacy, but I was willing to put the drug to the test. The phase 1/2 trial was meticulously carried out at BHC, with courageous volunteers. We learned that even the lowest starting dose, an estimate based on responses previously in healthy controls, resulted in a strong physiologic response in the first two ME/CFS subjects. Revisions were made to the protocol to revise the dosing regimen, with full disclosure to and oversight by the IRB and FDA. Once the study was complete, the contracted role of BHC ended; it then became Cortene’s responsibility to analyze the data. I have stayed on as a medical advisor to the company as the data were analyzed, the paper published, and next steps determined. Cortene is optimistic about the results, and I am pleasantly surprised by the results and hope the next phases of research can move forward.
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