Phase II trial of thymosin fraction 5 and thymosin alpha 1.
Dillman. R O RO; Beauregard. J J; Royston. I I; Zavanelli. M I MI
Key Findings
- Thymosin‑alpha‑1 and thymosin fraction 5 were well‑tolerated at the tested doses
- No tumor shrinkage was seen in colon, lung or kidney cancer patients
- The drugs did not produce measurable or lasting immune enhancement
Practical Outcomes
- For biohackers looking for longevity or performance gains, this trial suggests thymosin‑alpha‑1 offers no clear benefit and isn’t worth adding to a regimen based on current evidence.
Summary
In a small Phase II cancer study, thymosin‑alpha‑1 (and a related mix called thymosin fraction 5) didn’t shrink tumors or boost the immune system, even though earlier Phase I work showed they were safe.
Abstract
Previous Phase I trials have established the safety of administering thymosin fraction 5 and thymosin alpha 1 to patients with advanced cancer. These same trials also suggested potential immune-enhancing doses of these agents. In this study, 12 patients with colon cancer were treated with thrice weekly thymosin fraction 5 at a dose of 120 mg/m2, and 10 patients with non-small-cell lung cancer received thymosin alpha 1 at 1.2 mg/m2 thrice weekly. Five patients with hypernephroma also received one or both agents by a thrice weekly schedule. There were no tumor responses observed in any of these patients, and immune enhancement was neither obtained nor sustained. We conclude that at these doses and schedules, these hormones have very limited, if any, antitumor properties and that they are incapable of producing immune augmentation as defined by the assays used in this study.
Study Information
pubmed
1987