Thymosin Alpha1, 2mg

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Thymosin Alpha 1 Reduces the Mortality of Severe Coronavirus Disease 2019 by Restoration of Lymphocytopenia and Reversion of Exhausted T Cells
Yueping Liu, Yue Pan, Zhenhong Hu, Ming Wu, Chenhui Wang, Zeqing Feng, Congzheng Mao, Yingjun Tan, Ying Liu, Li Chen … Show moreAuthor Notes
Clinical Infectious Diseases, Volume 71, Issue 16, 15 October 2020, Pages 2150–2157,  https://doi.org/10.1093/cid/ciaa630
Published: 22 May 2020 Article history
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Abstract
Background
Thymosin alpha 1 (Tα1) had been used in the treatment of viral infections as an immune response modifier for many years. However, clinical benefits and the mechanism of Tα1 treatment for COVID-19 patients are still unclear.

Methods
We retrospectively reviewed the clinical outcomes of 76 severe COVID-19 cases admitted to 2 hospitals in Wuhan, China, from December 2019 to March 2020. The thymus output in peripheral blood mononuclear cells from COVID-19 patients was measured by T-cell receptor excision circles (TRECs). The levels of T-cell exhaustion markers programmed death-1 (PD-1) and T-cell immunoglobulin and mucin domain protein 3 (Tim-3) on CD8+ T cells were detected by flow cytometry.

Results
Compared with the untreated group, Tα1 treatment significantly reduced the mortality of severe COVID-19 patients (11.11% vs 30.00%, P = .044). Tα1 enhanced blood T-cell numbers in COVID-19 patients with severe lymphocytopenia. Under such conditions, Tα1 also successfully restored CD8+ and CD4+ T-cell numbers in elderly patients. Meanwhile, Tα1 reduced PD-1 and Tim-3 expression on CD8+ T cells from severe COVID-19 patients compared with untreated cases. It is of note that restoration of lymphocytopenia and acute exhaustion of T cells were roughly parallel to the rise of TRECs.

Conclusions
Tα1 treatment significantly reduced mortality of severe COVID-19 patients. COVID-19 patients with counts of CD8+ T cells or CD4+ T cells in circulation less than 400/μL or 650/μL, respectively, gained more benefits from Tα1. Tα1 reversed T-cell exhaustion and recovered immune reconstitution through promoting thymus output during severe acute respiratory syndrome–coronavirus 2 infection.
https://academic.oup.com/cid/article/71/16/2150/5842185
What Are The Benefits of Thymosin Alpha 1?
Immune enhancing peptide

Helps prevent infections such as the common cold or the flu and diseases

Reduces inflammation in the body
Suppresses tumor growth
Aids in the removal of acute or chronic infections
Has antibacterial, antiviral, and antifungal properties.
Supports the eradication of unhealthy cells (including cancer growth).
Protects your cells against oxidative stress and damage.
Inhibits viral replication
Improve symptoms associated with chronic fatigue
Study Description
Go to sections
Brief Summary:
Thymalfasin (thymosin alpha 1 or Ta1), the active pharmaceutical ingredient in ZADAXIN® injection, is a 28-amino acid synthetic peptide, identical to natural Ta1 produced by the thymus gland. Ta1 is a biological response modifier which activates various cells of the immune system, and is therefore expected to have clinical benefits in disorders where immune responses are impaired or ineffective, including acute and chronic viral and bacterial infections, cancers, and vaccine non-responsiveness. Patients with end-stage renal disease (ESRD) on hemodialysis, in addition to their intrinsic kidney disease and frequent burden of comorbidities, also have increased risk of exposure to communicable diseases as they are treated several times each week at hemodialysis centers with several other patients and clinic staff in attendance. The majority of patients are over 60 years of age and many are receiving immunosuppressive medications. Accordingly, ESRD patients are particularly susceptible to COVID-19 infection. Ta1 has been shown to be safely administered to hemodialysis patients. It is our hypothesis that a course of Ta1 administered to individuals with ESRD will reduce the rate and severity of infection with COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19
Drug: Thymalfasin
Phase 2

Detailed Description:
Patients with end-stage renal disease (ESRD) on hemodialysis, in addition to their intrinsic kidney disease and frequent burden of comorbidities, also have increased risk of exposure to communicable diseases as they are treated several times each week at hemodialysis centers with several other patients and clinic staff in attendance. The majority of patients are over 60 years of age and many are receiving immunosuppressive medications. Accordingly, ESRD patients are particularly susceptible to COVID-19 infection.

Thymalfasin (thymosin alpha 1, Ta1) is a naturally occurring peptide that has been evaluated for its immunomodulatory activities and related therapeutic potential in several conditions and diseases, including infectious disease and cancer. ZADAXIN, a synthetic form of Ta1, been has been used clinically in pilot studies for treatment of severe acute respiratory syndrome (SARS) and other lung infections including acute respiratory distress syndromeARDS) and chronic obstructive pulmonary disorder (COPD), as well as infections after bone marrow transplant]. Larger clinical trials have shown significant efficacy for treatment of severe sepsis and hepatitis B, along with certain cancers such as melanoma, hepatocellular, and lung cancer. Ta1 has also demonstrated improvement in response to vaccines in the elderly and in patients immunocompromised by renal disease. The beneficial clinical effects of Ta1 result from activation of toll-like receptor (TLR) 9 in dendritic and other immune system cells, resulting in augmentation of T helper (Th1) function, natural killer (NK) cell activity, and increased antibody responses to T-cell dependent antigens. Importantly, Ta1 also leads to an increase in IL-10 producing regulatory T cells, which create feedback inhibition of cytokine production, hence dampening immune response and preventing a pro-inflammatory cytokine storm.

It is our hypothesis that a course of Ta1 administered to individuals at high risk for COVID-19 infection (hemodialysis patients 60 years and older) will reduce the rate of COVID-19 infection and severity of infection with COVID-19, compared to untreated individuals in the same hemodialysis units with comparable risk. The study will also evaluate the need for hospitalization in those patients who do not become infected with COVID-19.

Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be centrally randomized to receive either study treatment drug (Ta1) or no Ta1. Randomization will be stratified by site.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Trial of Thymalfasin (Ta1) to Prevent COVID-19 Infection in Elderly Renal Dialysis Patients
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2021
Resource links provided by the National Library of Medicine
MedlinePlus related topics: Dialysis
U.S. FDA Resources
https://clinicaltrials.gov/ct2/show/NCT04428008

 

Thymosin A1 info

Thymosin Alpha-1 is a peptide, or small protein, produced naturally by the thymus gland. The thymus is where immune cells known as T cells mature and are released when prompted to do so by the T α 1 peptide. Specifically, T α 1 has been shown to enhance the function of certain immune cells, these white blood cells play pivotal roles in the body’s defense process to anyone with a depleted immune system or suffering from an infection.

Thymosin Alpha-1 is a protein that consists of 28 amino acids. Thymosin Alpha-1 is a significant component of Thymosin Fraction 5 which is responsible for the activity in repairing immune function. Thymosin Alpha-1 plays a vital role in the control of immunity, tolerance, and inflammation. It manages immune response via an initial action on the cells of the innate immune system and thus acts as an endogenous regulator of both inflammatory and adaptive immune responses.

 

Thymosin Alpha-1 Benefits

  • Enhances the function of certain immune cells
  • Effective for acute and chronic infections
  • Help eradicate the unhealthy cells and stop the infection
  • Exhibits antibacterial, antiviral and antifungal properties
  • Increases vaccine effectiveness
  • Protects against oxidative damage
  • Reduces scar tissue
  • May improve hair regrowth
  • Significant repair and regenerative properties
  • Improve muscular stamina

WHAT IS THYMOSIN ALPHA-1?

 

Serum thymosin α 1 levels in patients with chronic inflammatory autoimmune diseases

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5011367/

 

Thymosin Alpha 1 Reduces the Mortality of Severe Corona virus 2019 by Restoration of Lymphocytopenia and Reversion of Exhausted T Cells

 

https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa630/5842185

Peptide Therapy Handbook

For Healthcare Professionals

Thymosin alpha-1

Powered by Metabolic Code

2 THE AMERICAN ACADEMY OF ANTI-AGING MEDICINE

Thymosin alpha-1

Indications/Uses

Used for clinical conditions where immune support is necessary, including:

  • Hepatitis B & C
  • HIV/AIDS
  • Cancer – non-small cell lung (NSCLC), hepatocellular, malignant melanoma
  • Chemotherapy adjunct
  • Chronic inflammatory conditions; autoimmunity
  • Cystic fibrosis
  • Lyme disease
  • Blocks steroid-induced apoptosis of thymocytes
  • Depressed response to vaccinations; adjunct to flu vaccine o Geriatric immune support
  • DiGeorge’s syndrome
  • Other conditions requiring immune response modulation

Dosage:

SubQ General Dosage:

  • 3mg/ml 5ml vial
  • 1.5 mg SubQ every 3r d day
  • Treatment from 2 weeks for viral infection and 3 months or longer for HIV/ cancer / Hepatitis B, C or

complicated immune suppression or over-activation

  • Multiple over-lap of usage

ZadaxinTM Dosage:

  • 1.6 mg, injected SubQ, 2 times weekly for 6-12 months
  • Patients weighing < 40 kg, dosage adjusted to 40 mcg/kg, 2 times weekly.
  • May be used together with conventional antiretroviral regimens
  • Individual dosage requirements may vary based on clinical presentation

Warnings and Cautions

  • Thymosin alpha 1 peptide is reported safe in recommended dosages.
  • Since 1979, thymosin alpha-1 is well tolerated. Tα1 has demonstrated a very favorable toxicity profile

in more than 3,000 individuals treated to date, including patients with hepatocellular carcinoma, non–

small-cell lung cancer, melanoma, and hepatitis B and C. ,,,

  • Thymosin alpha 1 has been reported to be well tolerated even in patients with decompensated liver

disease, renal disease requiring hemodialysis and primary immunodeficient individuals.

  • As with all injections, redness and pain at the site of injection may be present.
  • Rare adverse reactions include erythema, transient muscle atrophy, polyarthralgia combined with hand

edema, and rash.

  • A transient increase in ALT to more than twice baseline value can occur during thymosin alpha 1

therapy. When ALT flare occurs, thymosin alpha 1 should generally be continued unless signs and

symptoms of liver failure are observed.

  • Use caution if administering to pregnant or nursing women.
  • Do not use in individuals being deliberately immunosuppressed.
  • Safety in pediatrics has not been established.

Summary

  • Thymosin alpha-1 is a synthetic thymic peptide used to improve immune responses in times of need.
  • Studies report thymosin alpha-1 : ,,,,,
  • Modulates innate immunity (pleiotropic)
  • Improves Th1 immune responses and helps balance Th1/Th2 o Promotes T cell (Tregs) differentiation

and maturation

  • Decreases T-cell apoptosis

THE AMERICAN ACADEMY OF ANTI-AGING MEDICINE 3

Thymosin alpha-1

  • Improves CD3+, CD4+ and CD8+
  • Improves production of IL-1 beta, IFN-γ, IL-2, IL-3, IL-6, IL-10 o Improves NK cell activity and TNF-alpha
  • Improves macrophages and B cells
  • Up regulates MHC Class I expression in antigen expressing cell
  • Tumor specific antigens; anti-tumor properties
  • Inhibits viral replication
  • Activates indoleamine 2,3-dioxygenase enzyme – dampens immunity
  • Improves dendritic cell tryptophan catabolism
  • Antioxidant properties – improves intracellular glutathione

Thymosin alpha 1 has been used to support immunity in over 3,000 patients and in over 70 clinical studies,

either as monotherapy or in conjunction with current allopathic medicines., The lack of significant side

effects with thymosin alpha 1 is in sharp contrast to other major immune response modulators such as

IFN and IL-2, which can lead to flu-like symptoms including malaise, fever, headache, chills and pulmonary

edema (with IL-2).

Thymosin alpha 1 helps the body induce effective host-derived immune effectors and balance the Th1

/ Th2 arms of immunity. These effector cells improve various immunomodulatory properties that lead

to augmentation of T lymphocyte function, including modulation of interleukin-2 (IL-2), stimulation of

interferon-g (IFN-g) production, induction of T lymphocyte and natural killer (NK) cells and stimulation of

thymopoiesis. Ta1 has also been reported to up-regulate MHC Class I expression in antigen-presenting

cells. Additionally, Ta1 down-regulates the activity of terminal deoxynucleotide transferase (TdT) in TdT1

thymocytes, suggesting a role for Ta1 in thymocyte maturation. Ta1 has also been found to antagonize both

activation induced (anti-CD3) and glucocorticoid-induced thymocyte apoptosis. It has also been reported

that Ta1 stimulates activity of Indoleamine-2,3-Dioxygenase (IDO), leading to an increase in FoxP3 IL10 producing regulatory T cells. This increase leads to feedback inhibition of cytokine production, hence

dampening immune response to prevent a pro-inflammatory cytokine storm and possibly autoimmune

phenomena.

Immune senescence, considered an aging process, has been related to a gradual decline in thymus

function and thymic hormone production. The lack of thymic hormones may contribute to the decline in

immune function, particularly the T cell component. In the elderly, antibody response after vaccination

is compromised when compared to response in young. A similar diminished antibody response has been

reported in patients with end-stage renal disease (ESRD) and in hemodialysis patients. In hemodialysis

patients, this has been attributed to incompetence in T cell-mediated immune responses.

Since thymosin alpha-1 can enhance T-cell-dependent specific antibody production, Ta1 can help augment

specific vaccine responses both in the elderly or in younger subjects in situations in which there are

suboptimal quantities of immunizing antigen available.

Zadaxin™

Zadaxin (thymalfasin, SciClone Pharmaceuticals, China) is a thymosin alpha-1 peptide that has

been evaluated for its immunomodulatory activities and related therapeutic potential in several

diseases, including chronic hepatitis B and C, acquired immunodeficiency syndrome (AIDS), primary

immunodeficiency diseases, depressed response to vaccination, and cancer. Zadaxin is currently in Phase III

trials for the treatment of hepatitis C and in Phase II trials for hepatitis B in the US.

DISCLAIMER: Statements made are for educational purposes and have not been evaluated by the US Food and Drug Administration

(FDA). They are not intended to diagnose, treat, cure, or prevent any disease. Most peptides are not regulated by the FDA. Always use a

licensed Compounding Pharmacy to prepare peptide products.

https://www.a4m.com/assets/pdf/covid-19-resources/Thymosin%20alpha%201%20prof%20monograph.pdf

4 THE AMERICAN ACADEMY OF ANTI-AGING MEDICINE

Thymosin alpha-1

1 GF Stefanini, FG Foschi, E Castelli , etal: Alpha-1-thymosin and transcatheter arterial chemoembolization in hepatocellular carcinoma

patients: A preliminary experience Hepatogastroenterology 45: 209– 215,1998

2 F Salvati, G Rasi, L Portalone , etal: Combined treatment with thymosin-alpha1 and low-dose interferon-alpha after ifosfamide in nonsmall cell lung cancer: A phase-II controlled trial Anticancer Res 16: 1001– 1004,1996

3 G Rasi, E Terzoli, F Izzo , etal: Combined treatment with thymosin-alpha1 and low dose interferon-alpha after dacarbazine in advanced

melanoma Melanoma Res 10: 189– 192,2000

4 Zadaxin prescribing information SciClone Pharmaceuticals. www.scicloneinternational.com 5 Goldstein AL. History of the discovery of the thymosins Ann N Y Acad Sci. 2007;1112: 1– 13.

6 Garaco E, Pica F, Serafino A, et al. Thymosin alpha-1 and cancer: action on immune effector and tumor target cells. Ann NY Acad Sci.

2012;1269:26-33.

7 Romani L, MorettiS, Fallarino F, et al. Jack of all trades: thymosin alpha-1 and its pleiotropy. Ann NY Acad Sci. 2012;1269:1-6.

8 Romani L, Bistoni F, Perruccio K, et al. Thymosin alpha 1 activates dendritic cell tryptophan catabolism and estraclishes a regulatory

environment for balance of inflammation and tolerance. Blood. 2006;108(7):2265-74.

9

Naylor PH. Zadaxin (thymosin alpha 1 ) for the treatment of viral hepatitis. Expert Opin Investig Drugs. 1999;8(3):281-7.

10 Billich A. Thymosin alpha 21. SciClone Pharmaceuticals. Curr Opin Investig Drugs. 2002;3(5):698-707.

11 HE C, Peng W, Li C, et al. Thymalfasin, a promising adjuvant therapy in small hepatocellular carcinoma after liver resection. Medicine

(Baltimore). 2017;96(16):e6606.

12 Yang X, Qian F, He H, et al. Effect of thymosin alpha-1 on subpopulations of Th1, Th2, Th17 and regulatory T cells (Tregs) in vitrol. Braz

J Med Biol Res. 2012;45(1):25-32.

13 Matteucci C, Grelli S, Balestrieri E, et al. Thymosin alpha 1 and HIV-1: recent advances and future prospectives. Future Microbiol.

2017;12:141-155.

14 Lopez-Alcorocho J, Vartolome J, Cotonat T, Carreno V. Efficacy of prolonged interferonalpha treatment in chronic hepatitis B patients

with HBeAb: comparison between 6 and 12 months of therapy. J Vir Hep. 1997;4(suppl 1):27-32.

15 Yang X, Qian F, He H, et al. Effect of thymosin alpha-1 on subpopulations of Th1, Th2, Th17 and regulatory T cells (Tregs) in vitrol. Braz

J Med Biol Res. 2012;45(1):25-32.

16 Giuliani C, Napolitano G, Mastino A et al. Thymosin-alpha1 regulates MHC class I expression in FRTL-5 cells at transcriptional level.

Eur J Immunol 2000; 30:778–86.

17 Baumann CA, Badamchian M, Goldstein AL. Thymosin alpha 1 is a time and dose-dependent antagonist of dexamethasome-induced

apoptosis of murine thymocytes in vitro. Int J Immunopharmacol. 2000;22(12):1057-66.

18 Palmer DB. The effect of age on thymic function. Front Immunol. 2013;4:316.

19 Ershler WB, Gravenstein S, Geloo ZS. Thymosin alpha 1 as an adjunct to influenza vaccination in the elderly. Ann NY Acad Sci.

kidneys and COVID prevention

https://clinicaltrials.gov/ct2/show/NCT04428008

A Reappraisal of Thymosin Alpha1 in Cancer Therapy

Claudio Costantini1*Marina M. Bellet1Marilena Pariano1Giorgia Renga1Claudia Stincardini1Allan L. Goldstein2Enrico Garaci3 and Luigina Romani1*

  • 1Department of Experimental Medicine, University of Perugia, Perugia, Italy
  • 2Department of Biochemistry and Molecular Medicine, School of Medicine and Health Sciences, The George Washington University, Washington, DC, United States
  • 3University San Raffaele and IRCCS San Raffaele, Rome, Italy

Thymosin alpha1 (Tα1), an endogenous peptide first isolated from the thymic tissue in the mid-sixties, has gained considerable attention for its immunostimulatory activity that led to its application to diverse pathological conditions, including cancer. Studies in animal models and human patients have shown promising results in different types of malignancies, especially when Tα1 was used in combination with other chemo- and immune therapies. For this reason, the advancements in our knowledge on the adjuvant role of Tα1 have moved in parallel with the development of novel cancer therapies in a way that Tα1 was integrated to changing paradigms and protocols, and tested for increased efficacy and safety.

 

https://www.frontiersin.org/articles/10.3389/fonc.2019.00873/full

 

The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and dosage and administration of thymosin alpha-1 (TA1) are reviewed.

https://www.medscape.com/viewarticle/406967

 

 

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