Comprehensive Review of the Safety and Efficacy of Thymosin Alpha 1 in Human Clinical Trials
ABSTRACT
Link full publications: http://alternative-therapies.com/oa/pdf/Dinetz.pdf
Pubmed Link: https://pubmed.ncbi.nlm.nih.gov/38308608/
Objective • This study aims to assess the safety and efficacy of Thymosin Alpha 1 (Tα1) through a comprehensive narrative review of clinical studies involving over 11 000 human subjects in more than 30 trials. The focus was on Tα1’s application in COVID-19, autoimmune conditions, and cancer treatment, with implications for future considerations. Methods • We systematically searched articles relevant to critical studies on COVID-19, infectious diseases, cancer, and autoimmune diseases indexed on Pubmed, Google Scholar, and Cochrane Library. Our focus was on evaluating the safety and efficacy of Tα1 in human subjects. Clinical trials conducted worldwide involving diverse populations were analyzed to assess the safety and effectiveness of Tα1. The review examines explicit outcomes in over 11 000 human subjects, emphasizing its role in addressing COVID-19, autoimmune conditions, and cancer treatment.
Results • Contrary to the FDA’s restriction on Tα1 and 21 additional peptides in 2023, our analysis reveals consistent evidence of Tα1’s safety and efficacy. The peptide has demonstrated significant effectiveness in treating various conditions, including COVID-19, autoimmune disorders, and cancer. This review summarizes conclusions drawn from a comprehensive examination of clinical trials worldwide.
Conclusions • Based on substantial evidence from clinical trials, Tα1 emerges as a well-tolerated and effective immune modulator.
The FDAs restriction appears unfounded, as Tα1 has shown safety and efficacy beyond the initially specified conditions. Urgent attention and intervention are warranted to ensure the continued availability of this life-saving peptide through prescription. Therefore, it is recommended that the FDA permits 503A compounding pharmacies to compound Tα1, considering its potential to treat a variety of conditions effectively. (Altern Ther Health Med. 2024;30(1):6-12).
Elliot Dinetz, MD, Voluntary Associate Professor, Department of Family Medicine, Miller School of Medicine University of Miami, Timeless Health Medical Center, Miami, Florida, United States. Edwin Lee, MD, Assistant Professor of Internal Medicine at the University of Central Florida College of Medicine, FACE Institute for Hormonal Balance, Orlando, Florida, United States.
INTRODUCTION
Thymosin Alpha 1 (Tα1) is a 28-amino acid peptide derived from calf thymus tissue by Dr. Allan L. Goldstein in the 1970s.1 The synthetic form of this peptide, known as thymalfasin, has received approval in more than 35 countries for treating hepatitis B and C and as an immune enhancer in various diseases.2 Despite being unapproved by the FDA in the USA, Tα1 gained FDA orphan drug approval from 1991 to 2006, allowing compassionate use in four clinical trials addressing conditions such as hepatitis B, thymus gland absence in children, DiGeorge Syndrome, hepatocellular carcinoma, and malignant melanoma.3 Tα1 plays a crucial role in immune system regulation, exerting influence over various immune cell subsets, including dendritic cells, T cells, and natural killer cells, integral to both innate and adaptive immunity.4 Tα1 has been studied extensively for decades, showing its immunomodulatory effects, and is typically administered via subcutaneous injection, though intravenous administration is also possible. It has demonstrated a promising impact in enhancing T cell function and improving immune responses in both animal and human studies, and these findings hold significance for the treatment of diverse medical conditions, especially those associated with immune dysfunction. Human clinical trials have demonstrated that Tα1 possesses antiviral, autoimmune-mitigating, and anti-cancer properties, thereby suggesting its role in contributing to the treatment of widespread medical conditions. This study specifically investigated the therapeutic domains of Tα1, examining its antiviral, autoimmune mitigating, and anti-cancer properties. The objective was to assess the contribution of Tα1 to the treatment of prevalent.
SAFETY AND FUTURE PROMISE of Tα1
in Addressing Immune Dysregulation Tα1 emerges as a beacon of hope, highlighting its substantial benefits and flawless safety record. Notably, no documented concerns for harm or drug-drug interactions have been identified, positioning Tα1 as a promising solution for patients grappling with challenging medical conditions rooted in immune dysregulation. However, the disconcerting FDA scrutiny of Tα1, along with other proven peptides, raises significant apprehensions. Unlike many medications, Tα1 has navigated preclinical development, large phase 3 clinical studies, and current medical practice seamlessly, with no reported instances of misuse or harm in the extensive literature review. The recent FDA ban on peptides, including Tα1, raises concerns about potential implications. If the ban persists, the public may turn to online sources that claim to provide peptides “for research purposes only,” introducing uncertainty about their quality. This situation poses a significant risk to patient safety. Instead, ensuring a stable supply for healthcare providers by allowing regulated compounding pharmacies to continue their operations is a more prudent approach. These pharmacies adhere to rigorous quality control standards and accreditation requirements established by the FDA. Regular site visits, compliance with quality control measures, and specialty certifications are integral parts of their practice. Protecting the existence of 503A compounding pharmacies is crucial to ensure the continued production of safe and sterile Tα1 in accordance with the FDA’s stringent standards.
CONCLUSION
In conclusion, Tα1 has demonstrated its safety with over 11 000 subjects enrolled and clinically evaluated in highquality studies, with no significant harm ever reported. Tα1 has proven lifesaving when used to treat various conditions without resulting in long-term complications or interactions seen with other medications. Studies of Tα1 have increased exponentially, as reflected in the literature, supporting its continued use and exploration for additional treatment options. Post-marketing surveillance, based on the experience of more than 600 000 treated patients with this peptide, affirms Tα1’s excellent tolerability. Discontinuing its compounding would likely cause more harm than good. Therefore, clinicians should retain access to such treatment options and have the authority to prescribe them based on evidence-based medicine, free from undue influence. Unless there is a substantiated case against a therapy, the removal of the ability to compound or produce a substance like Tα1 is unwarranted. Numerous pharmaceuticals have gained approval with far less safety data, only to be withdrawn from the market later due to harmful effects. Disallowing this drug would create a double standard and raise ethical concerns. Tα1 should be permitted for compounding by a 503A compounding pharmacy because it holds treatment implications across multiple medical specialties and has established a long-term safety profile to meet patient needs.
