Thymosin Alpha-1 3mg

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Thymosin Alpha-1 3mg

Thymosin Alpha-1 3mg

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Thymosin Alpha-1 3MG 

 

Thymosin Alpha 1 (Tα1) research:

Mice have been studied for response to Tα1 in the setting of cystic fibrosis.  Few medications help CF, and it is a complex disease process with impaired chloride permeability, persistent lung inflammation, and generalized disease progression.  Thymosin alpha 1 displayed two properties spefically helpful to CF patients; reduction of inflammation, and increased cystic fibrosis transmembrane conductance regulator (CFTR) maturation.  The authors believe Tα1 has strong potential to be an efficacious single-molecule-based therapy for CF patients.  [1]

 

Thymosin Alpha 1 is the agent found to restore immune function in mice that have undergone thymectomy.  Tα1 has a variety of actions, activating and stimulating signal pathways and initiating production of immune related cytokines.  Due to its stimulant effects, the agent is expected to show benefit for immunosuppression, due to aging, infection, or cancer.  Studies have demonstrated improvements in immune system cell subsets and prove a range of diseases for which Tα1 may be beneficial.  [2]

 

Blood samples were taken from children with acute lymphoblastic leukemia, cultured, stained, and analyzed in two groups – freeze-thaw antigen loaded dendritic cells with thymosin alpha 1, and another group of the same type of cells without thymosin alpha 1.  Using a variety of chemical assays to evaluate their function, the treated cells showed the killing rate of cytotoxic T-lymphocytes was significantly higher than those in the control group.  The authors suggest Tα1 may be a suitable immunomodulator for treatment of blood cancers.  [3]

 

Thymosin alpha 1 was historically reviewed in Expert Opinions on Biological Therapy in 2015, for specific application in oncology and chemotherapy.  The review specifically covered effects, mechanisms of action, and treatment protocols, with specific focus on metastatic melanoma and lung cancer controlled clinical trials.  They recommend the use of Tα1 in these particular applications.  [4]

 

Tα1 has been evaluated for improving vaccine response in difficult-to-treat populations, such as those immune suppressed due to age or need for hemodialysis.  During the 2009 pandemic H1N1 influenza outbreak, mouse and ferret studies showed that the use of Tα1 allowed for fewer injections of vaccine to reach resistance than in previous clinical studies.  [5]  This was further demonstrated in human hemodialysis patients during the same 2009 influenza outbreak using single-injection doses of 3.2 or 6.4mg; both groups saw improved rates of vaccine response compared to control group with no adverse effects reported. [6]

 

Melatonin is closely linked to the nocturnal increase in serum Tα1 in both rats and humans.  This may be related to why decreased sleep is associated with increased risks of infections and cancers, and may also correlate with immune dysregulation as we age.  [7]

 

Tα1 has been studied for its effects on atherosclerosis.  In a rabbit study with a high cholesterol diet, the rabbits in the experimental group received 25mcg/kg thymosin alpha 1 intraperitoneally every day for 14 days.  The treated rabbits were significantly lower in levels of cholesterol, and most of the lipid plaques were replaced by fibrous tissue.  This suggests that Tα1 may help normalize blood lipid levels and substantially protect endothelial cells against free radical injury.  [8]

 

Tα1 was shown to reduce the growth of human non-small cell lung cancers, both in patients and in lab experiments.  Using 10mcg/day subcutaneously in the experimental mouse group significantly inhibited progression of xenograft formation.  [9]

 

Clinical Studies with Thymosin Alpha 1 (Tα1)

Thymosin Alpha 1 was studied for its potential benefit in severe sepsis.  Severe sepsis is an acute, high-risk condition resulting from infection and the body’s response to it; it is frequently fatal.  Six tertiary care center Intensive Care Units in China were used with a total of 361 patients enrolled.  The primary outcome was all-cause death at 28 days, with secondary outcomes measuring changes in the Sequential Organ Failure Assessment (SOFA) and levels of monocyte human leukocyte antigen-DR on days 0, 3 and 7 in both groups.  The arm treated with Tα1 had 26% fatality by day 28, the group treated with standard methods had 35% fatality.  Otherwise there was no significant difference in days on ventilators, length of ICU stay, and there were no significant reactions to Tα1.  [10]  Highest odds of survivability correlated with highest doses used (>1.6mg/day) [11]

 

A study looking at Thymosin Alpha 1 levels was undertaken in a rheumatology clinic in Italy in 2016.  The study showed that the Healthy Control comparison group had substantially higher levels of Tα1 than the study patients.  Those with rheumatoid arthritis and psoriatic arthritis had markedly lower levels of Tα1 than the control group.  The patients who were being treated with disease-modifying anti-rheumatic drugs (DMARDs) and steroids had higher levels than DMARD-only or no-treatment patients, suggesting both anti-inflammatory properties of Tα1, and that it can be stimulated with certain medications.  [12]

 

Thymosin alpha 1 was studied in the setting of acute exacerbation of chronic obstructive pulmonary disease (AECOPD).  Eighty-four patients were enrolled and split randomly into control and experimental groups.  All received standard COPD treatment, with the control group receiving placebo injections, and the experiment group receiving subcutaneous injections of Tα1.  A variety of measurements were taken, including partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2), and pulmonary function, before and after the study period.  All of them improved, as did CD4, serum interferon, CD8, interleukin-4 and -8, and leukotriene B4 in the study group.  The authors state that Tα1 plus routine treatment could improve the immune and inflammatory responses of COPD patients, reducing recurrent exacerbations.  [13]

 

Patients with bone marrow transplants may be at particular risk of infectious diseases, including hepatitis B, hepatitis C, Aspergillosis, and sepsis from a variety of organisms.  Tα1 was evaluated in historic review of infectious disease, and due to its excellent safety profile, near-complete lack of toxicity, and response, is considered an ideal agent in many respects.  [14]

 

A clinical trial is currently underway evaluating Tα1 combined with entecavir for the treatment of hepatitis B related cirrhosis.  This was based on prior studies which showed Tα1 monotherapy to be effective in suppressing viral replication when compared with untreated control patients or those treated conventionally with interferon.  Most of the combination therapy with Tα1 plus lamivudine or interferon showed better effects on hepatitis b DNA suppression than standard medications alone.  [15]

 

Tα1 has been studied in patients with severe acute pancreatitis.  A total of 24 patients were enrolled, half received conventional therapy, half received immunomodulatory therapy using Tα1 3.2mg injected twice daily for 7 days.  The experimental group had labs drawn on admission (day 0), and days 8 and 28.  Labs were improved in the experimental group, which also had shorter ICU length of stay.  [16]

 

A historic review of Tα1 use was completed in 2009, and discussed benefits found in a variety of disease including sepsis, acute cytomegalovirus infection, tuberculosis, acute respiratory distress syndrome (ARDS), severe acute respiratory syndrome (SARS), hepatitis B and C, stage IV melanoma, pneumonias in critical patients.  [17]

 

Application of Tα1 was considered for avulsed (traumatically extracted) teeth.  The study had two groups, one reimplanted with Tα1, one with saline.  The treated group showed improved interferon, tumor necrosis factor alpha, and white blood cell levels compared to the control group, and also demonstrated greater periodontal healing with less tooth movement and greater lifetime of the reimplanted teeth.  [18]

 

Cytomegalovirus (CMV) is a common viral agent which does little to most people, but is a potentially lethal infection in an immune suppressed host, eg., following organ transplant.  Tα1 was studied in patients with renal transplant who suffered acute respiratory distress syndrome (ARDS) due to CMV.  The group treated with Tα1 1.6mg subcutaneously every day, or every other day, had substantial improvement clinically over the control group, with a more successful rescue rate (78.1% vs 50%), and markedly reduced fatality (21.9% vs 50%).  CD4 and CD8 cell counts were also much higher on days 7, 14, and 21 in the treatment group than the control group.  [19]

 

A cost-benefit analysis of Hepatitis C treatment was conducted to evaluate cost of no treatment, cost of dual-agent treatment (peginterferon with ribavirin), or triple-agent treatment (peginterfereon, ribavirin, and Tα1).  The Tα1 group saved 23% compared to the dual-agent group, and had the highest efficacy of the treatments evaluated.  [20]

 

A Croatian study published in 2000 discusses a variety of issues related to the complexities of wound treatment and healing, including method of wound closure, antibiotics, malnutrition, blood sugar, steroid use, etc.  Various agents are also discussed which can assist wound healing, specifically that of Tα1 which is shown to accelerate angiogenesis and wound healing.  [21]

 

Immunosuppressed mice with systemic Candida Albicans infection were evaluated for response with fluconazole (an antifungal drug), or fluconazole plus Tα1.  The experimental Tα1 group showed additive effect compared to the control-treatment group, due to a direct antifungal action and activation of immunocompetence.  [22]

 

A 1994 study on HIV treatment with Tα1, interferon alpha, and zidovudine, showed that combination therapy maintained CD4 counts of 200-500/mm3, and that the effect persisted.  This effect was not seen in patients treated with zidovudine alone, or associated with other single agents.  These data resulted in the Italian Ministry of Health initiating a controlled double-blind clinical trial.  [23]

 

The Wilms tumor is a solid cancer that forms in children, with a nominal fatality rate of 8 in one million.  A case report in Korea combined inhaled, orally ingested, and rectally placed plant-derived medicines, with hyperthermia, and Tα1.  Her metastatic liver tumor was gone in approximately 8 months, and the lung tumor was stable without any progression.  [24]

 

References

1 - Thymosin α1 represents a potential potent single-molecule-based therapy for cystic fibrosis.  Romani L, Oikonomou V, Moretti S, Iannitti RG, D'Adamo MC, Villella VR, Pariano M, Sforna L, Borghi M, Bellet MM, Fallarino F, Pallotta MT, Servillo G, Ferrari E, Puccetti P, Kroemer G, Pessia M, Maiuri L, Goldstein AL, Garaci E.  Nat Med. 2017 May;23(5):590-600. doi: 10.1038/nm.4305. Epub 2017 Apr 10.  PMID: 28394330

 

2 - Immune Modulation with Thymosin Alpha 1 Treatment.  King R, Tuthill C.

Vitam Horm. 2016;102:151-78. doi: 10.1016/bs.vh.2016.04.003. Epub 2016 May 24. Review.  PMID:  27450734

 

3 - Effect of thymosin α₁ on the phenotypic and functional maturation of dendritic cells from children with acute lymphoblastic leukemia.  Li X, Liu X, Zhao Y, Zhong R, Song A, Sun L.  Mol Med Rep. 2015 Oct;12(4):6093-7. doi: 10.3892/mmr.2015.4153. Epub 2015 Jul 30.  PMID:  26239360

 

4 - Historical review on thymosin α1 in oncology: preclinical and clinical experiences.

Garaci E, Pica F, Matteucci C, Gaziano R, D'Agostini C, Miele MT, Camerini R, Palamara AT, Favalli C, Mastino A, Serafino A, Sinibaldi Vallebona P.  Expert Opin Biol Ther. 2015;15 Suppl 1:S31-9. doi: 10.1517/14712598.2015.1017466. Epub 2015 Jun 22. Review.  PMID:  26096345

 

5 - Thymosin α1 continues to show promise as an enhancer for vaccine response.

Tuthill C, Rios I, De Rosa A, Camerini R.  Ann N Y Acad Sci. 2012 Oct;1270:21-7. doi: 10.1111/j.1749-6632.2012.06680.x.  PMID:  23050813

 

6 - Thymosin-alpha 1 (Zadaxin) enhances the immunogenicity of an adjuvated pandemic H1N1v influenza vaccine (Focetria) in hemodialyzed patients: a pilot study.

Carraro G, Naso A, Montomoli E, Gasparini R, Camerini R, Panatto D, Tineo MC, De Giorgi L, Piccirella S, Khadang B, Ceracchi M, De Rosa A.  Vaccine. 2012 Feb 1;30(6):1170-80. doi: 10.1016/j.vaccine.2011.12.014. Epub 2011 Dec 14.  PMID:  22178096

 

7 - Melatonin is responsible for the nocturnal increase observed in serum and thymus of alpha1-thymosin and thymulin concentrations: observations in rats and humans.

Batmanabane M.  J Neuroimmunol. 2007 Feb;183(1-2):239; author reply 240. Epub 2006 Nov 22. No abstract available.   PMID:  17125848

 

8 - Thymosin alpha-1: evidence for an antiatherogenic effect.  Ademoglu E, Gökkuşu C, Oz B.  Ann Nutr Metab. 1998;42(5):283-9.  PMID:  9812019

 

9 - Thymosin alpha 1 down-regulates the growth of human non-small cell lung cancer cells in vitro and in vivo.  Moody TW, Fagarasan M, Zia F, Cesnjaj M, Goldstein AL.

Cancer Res. 1993 Nov 1;53(21):5214-8.  PMID:  8221658

 

10 - The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial.  Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X.  Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.

 

11 - Thymosin alpha1 based immunomodulatory therapy for sepsis: a systematic review and meta-analysis.  Li C, Bo L, Liu Q, Jin F.  Int J Infect Dis. 2015 Apr;33:90-6. doi: 10.1016/j.ijid.2014.12.032. Epub 2014 Dec 19. Review.  PMID:  25532482

 

12 - Serum thymosin α 1 levels in patients with chronic inflammatory autoimmune diseases.  Pica F, Chimenti MS, Gaziano R, Buè C, Casalinuovo IA, Triggianese P, Conigliaro P, Di Carlo D, Cordero V, Adorno G, Volpi A, Perricone R, Garaci E.

Clin Exp Immunol. 2016 Oct;186(1):39-45. doi: 10.1111/cei.12833. Epub 2016 Aug 1.

PMID:  27350088

 

13 - Thymosin α1 plus routine treatment inhibit inflammatory reaction and improve the quality of life in AECOPD patients.  Jia Z, Feng Z, Tian R, Wang Q, Wang L.

Immunopharmacol Immunotoxicol. 2015;37(4):388-92.  PMID:  26250523

 

14 - Historical review of thymosin α 1 in infectious diseases.  Camerini R, Garaci E.

Expert Opin Biol Ther. 2015;15 Suppl 1:S117-27. doi: 10.1517/14712598.2015.1033393. Epub 2015 Jun 22. Review.  PMID:  26098768

 

15 - Thymosin alpha-1 treatment in chronic hepatitis B.  Wu X, Jia J, You H.  Expert Opin Biol Ther. 2015;15 Suppl 1:S129-32. doi: 10.1517/14712598.2015.1007948. Epub 2015 Feb 1.  PMID:  25640173

 

16 -  Thymosin alpha 1 is associated with improved cellular immunity and reduced infection rate in severe acute pancreatitis patients in a double-blind randomized control study.  Wang X, Li W, Niu C, Pan L, Li N, Li J.  Inflammation. 2011 Jun;34(3):198-202. doi: 10.1007/s10753-010-9224-1. Erratum in: Inflammation. 2011 Jun;34(3):222-3.

PMID: 20549321

 

17 - From lab to bedside: emerging clinical applications of thymosin alpha 1.

Goldstein AL, Goldstein AL.  Expert Opin Biol Ther. 2009 May;9(5):593-608. doi: 10.1517/14712590902911412 . Review.  PMID:  19392576

 

18 - Thymosin alpha 1 provides short-term and long-term benefits in the reimplantation of avulsed teeth: a double-blind randomized control pilot study.  Loo WT, Dou YD, Chou WK, Wang M.  Am J Emerg Med. 2008 Jun;26(5):574-7. doi: 10.1016/j.ajem.2007.09.007.  PMID:  18534287

 

19 - Immunoregulation of thymosin alpha 1 treatment of cytomegalovirus infection accompanied with acute respiratory distress syndrome after renal transplantation.

Ji SM, Li LS, Sun QQ, Chen JS, Sha GZ, Liu ZH.  Transplant Proc. 2007 Jan-Feb;39(1):115-9.  PMID:  17275486

 

20 - Cost-effectiveness of chronic hepatitis C treatment with thymosin alpha-1.

García-Contreras F, Nevárez-Sida A, Constantino-Casas P, Abud-Bastida F, Garduño-Espinosa J.  Arch Med Res. 2006 Jul;37(5):663-73.  PMID:  16740439

 

21 - [The modern approach to wound treatment].  Komarcević A.  Med Pregl. 2000 Jul-Aug;53(7-8):363-8. Review. Croatian.  PMID:  11214479

 

22 - Combined effect of fluconazole and thymosin alpha 1 on systemic candidiasis in mice immunosuppressed by morphine treatments.  di Francesco P, Gaziano R, Casalinuovo IA, Belogi L, Palamara AT, Favalli C, Garaci E.  Clin Exp Immunol. 1994 Sep;97(3):347-52.  PMID:  8082290

 

23 - Combination treatment with zidovudine, thymosin alpha 1 and interferon-alpha in human immunodeficiency virus infection.  Garaci E, Rocchi G, Perroni L, D'Agostini C, Soscia F, Grelli S, Mastino A, Favalli C.  Int J Clin Lab Res. 1994;24(1):23-8.  PMID: 7910053

 

24 - Case Rep Oncol. 2016 Feb 20;9(1):119-25. doi: 10.1159/000443724. eCollection 2016 Jan-Apr.  Stage IV Wilms Tumor Treated by Korean Medicine, Hyperthermia and Thymosin-α1: A Case Report.  Lee D1, Kim SS1, Seong S1, Cho W2, Yu H2.