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Clinical Trial FC-US-001

Updated: Jun 21

June 21, 2024 The last subjects for the clinical trial using FC-12738, affectionally called TVALA, had their final follow up visit on June 14. All is going well and the data will be exhaustively examined. I'm happy to say that there were no adverse events or concerns. The humans mirrored the animals studies, consistency is always good in science! The final study report will issue in a few months and we can move the studies into ALS patients. The protocol for the next study is ready, we'd like to accelerate the work so we are asking FDA to grant us the ability to go into a larger study in ALS patients, multiple dose, rather than the single dose that they approved. Fingers crossed!

May 24, 2024 The two sentinel subjects for cohort 3 were dosed and released. All went well! We are looking forward to dosing the remaining subjects in this last cohort. We are thankful to these people, we are learning the human pK levels and that in humans the drug has a half-life of over 2.5 hours. These data help us prepare to dose patients with ALS.

May 22, 2024 We are pleased to announce that the clinical trial is going well! The second of three cohorts were dosed, evaluated, and released. The results of the safety review committee were positive, the third group of normal subjects will begin screening and entry into the study. After analysis and if all goes as we expect we will move to the Phase 1a or a Phase 2 study in ALS patients. We got some preliminary pharmacokinetic data from the first cohort that confirms our plasma half-life of 2.41 hours. Thymopentin has a half-life of 23 seconds. We will know more, soon, stay tuned!

June 6, 2024 The final six Subjects are entering the clinical trial site today. They will be dosed, stay three days and then be released. Day 8 will be the final check and this study will begin the lengthy process of data evaluation, study writing, study submission to FDA, and FDA review. We are anxious to get on the the next phase and that is giving our drug to ALS patients. We consider that a win!

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