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PubMed1998

Isothermal and nonisothermal decomposition of thymopentin and its analogs in aqueous solution.

PURPOSE: The degradation kinetics of thymopentin (RKDVY) and its analogs (RKDVW and RPDVY) in aqueous solution was studied by isothermal and nonisothermal methods. METHODS: The isothermal decomposition of thymopentin and its analogs was investigated as a function of pH (2-10), temperature (37, 57, and 80 degrees C) and ionic strength (micro = 0.02 to 1). Nonisothermal decomposition studies were performed using a linear temperature programmer. The temperature increasing rate was set to 0.25 degrees C per hour and the temperature interval varied from 40 to 88 degrees C. RESULTS: The decomposition of thymopentin and its analogs followed first order kinetics. The dependence of the rate constant on temperature followed a linear Arrhenius plot. This indicated that the degradation mechanism of thymopentin and its analogs might be the same within the temperature range studied. The energies of activation were found to be in close agreement for the isothermal and nonisothermal studies, suggesting that the nonisothermal studies may save considerable amount of time in the early stages of drug development. The logK-pH profile of thymopentin suggests that maximum stability is achieved in the pH range of 6-8. CONCLUSIONS: These results indicate that the nonisothermal methodology provides an attractive alternative to isothermal methods, as it requires a much lower amount of both material and time, to determine the peptide stability and to estimate the shelf-life for peptide pharmaceutical preparations.

Drug Stability↗
PubMed1988

[Immunomodulating therapy in chronic polyarthritis with thymopentin. A multicenter placebo-controlled study of 119 patients].

In a multicenter, placebo-controlled and randomized double-blind trial 119 patients with rheumatoid arthritis were treated with thymopentin, an immunoregulating drug. The data of 107 patients were complete enough to be evaluated: 51 were given intravenous injections over ten minutes of 50 mg thymopentin three times weekly, 56 were similarly treated with a placebo solution. Significant improvement of five among nine clinical criteria were obtained with thymopentin after the third week of treatment. The response rate (improvement of a clinical parameter by at least 40%) was significantly greater for all clinical parameters in the thymopentin group. Regression to a functionally more favourable class (Steinbrocker's classification) occurred in seven thymopentin-treated, but in none of the placebo-treated patients. The improvement gradually subsided over four weeks after the end of treatment. There were no changes during the trial with respect to immunological, biochemical or haematological findings. Except for one systemic allergic reaction there were no side effects.

Adjuvants, Immunologic↗
PubMed1996

The prognostic significance of serum viral load, codon 215 reverse transcriptase mutation and CD4+ T cells on progression of HIV disease in a double-blind study of thymopentin.

OBJECTIVE: To determine in asymptomatic HIV-infected subjects the prognostic value of virion reverse transcriptase (RT) codon 215 mutation, serum HIV RNA level, CD4+ T-cell count and immune complex dissociated (ICD) p24 level. The retrospective evaluation of thymopentin treatment effect on subjects in high risk groups for progression was a secondary objective. PARTICIPANTS: Zidovudine (ZDV)-experienced asymptomatic HIV-infected subjects (n = 352) who had been enrolled in a 48-week placebo-controlled double-blind trial of thymopentin treatment were studied. METHODS: Post hoc analyses were conducted to determine which subjects at study entry were at greater risk for progression to AIDS-related complex (ARC), AIDS or death, and to determine the effect of treatment on these subjects. Four potential prognostic variables (virion RT codon 215 mutation, circulating HIV virion RNA copies, CD4+ T-cell count, and ICD p24) were evaluated by dichotomizing subjects for each variable based on the median of the observed values. CD4+ T-cell count was evaluated prospectively, whereas frozen samples were evaluated under blinded conditions for the other variables after the study was completed. RESULTS: The presence of the codon 215 mutation [P = 0.044; relative hazard (RH), 2.6], > or = 20,000 HIV RNA copies/ml (P = 0.002; RH, 5.5), and < 350 CD4+ cells 10(6)/l (P = 0.042; RH, 2.2) were prognostic factors, and > or = 30 pg/ml ICD p24 level (P = 0.52; RH, 1.4) was not a prognostic factor in predicting progression. Subjects were prestratified by previous ZDV use (< or = 6 or > 6 months). Across both strata thymopentin delayed treatment progression to ARC, AIDS, or death (P = 0.015; RH, 3.0). This effect was magnified in the ZDV-experienced subjects at greater risk, where thymopentin delayed progression compared to placebo in the presence of the codon 215 mutation (P = 0.007; RH, 10.1), > or = 20,000 RNA copies/ml (P = 0.012; RH, 8.9), and CD4+ T-cell count < 350 x 10(6)/l (P = 0.005; RH, 10.4). CONCLUSIONS: Codon 215 mutation, serum HIV RNA and CD4 T-cell count are independent predictors of progression in ZDV-experienced asymptomatic subjects. Furthermore, thymopentin delays HIV disease progression in the presence of a key ZDV resistance mutation as well as high viral load and low CD4+ T-cell counts.

Adjuvants, Immunologic↗
PubMed2003

[Stability evaluation of thymopentin in preparation process].

OBJECTIVE: To observe whether thymopentin is stable in the preparation process. METHODS: Using HPLC method, we investigated the influence of different temperature, sonification time and pH value on thymopentin. RESULTS: The optimum storage condition for preservation of thymopentin was found to be a freezing environment. Thymopentin would not be degraded in the water bath of 60 degrees C for 24 hours or in different phosphate buffer solution (PBS) (pH 2, 5, 5, 7) under 37 degrees C for 24 hours. The sonification time within 15 minutes was determined to be safe for the preparation. CONCLUSION: The experiment result indicates that thymopentin is stable during the whole preparation process.

Chromatography, High Pressure Liquid↗
PubMedDate not supplied

[Variations of the immunological parameters and the clinical response in 25 children treated with thymopentin].

We studied the effects of thymopentin on 25 children aged between 15 months and 11 years, suffering from relapsing herpes, malnutrition and recurrent infections of respiratory tract. None of these children had previously received vaccines or immunostimulating drugs. Our purpose was to test thymopentin efficacy on various pathologies. We carried out a series of blood tests before, during and after drug administration in order to evaluate the variations of immunological parameters (IgA, IgG, IgM, IgAs, C3, C4 and cellular immunity), as well as changes in weight and height. Thymopentin was administered at a dose of 0.5 mg/Kg three times a week for three weeks. Seric IgA (Tab. 2) were also affected by thymopentin. As far as cellular immunity is concerned we observed a progressive increase of CD3 and CD8 during thymopentin treatment. Tolerability was excellent. Only one child had a slight fever that disappeared at the end of treatment. No hematological disorders were reported.

Child↗
PubMed1991

[Evaluation of the use of thymopentin in patients with progressive systemic sclerosis].

Although the exact etiology of progressive systemic sclerosis (SSP) is still unknown, it is felt that immunologic disorders may be implicated in its pathogenesis. On the basis of these considerations, an open study with an immunomodulating drug, thymopentin, was performed in 20 SSP outpatients. These subjects were initially treated with thymopentin three times a week for three consecutive months (phase I); during a second study phase lasting three months, 10 patients continued to receive thymopentin and the remaining 10 placebo (phase II). A significant improvement in various clinical, laboratory and instrumental findings was seen following thymopentin treatment. During phase II, those on placebo regressed to basal conditions, while an added improvement was noted in those who continued with thymopentin.

Female↗
PubMed1987

Influence of thymopentin on postsurgical immune deficiency: a clinical pilot study.

The effect of a single dose (50 mg) of thymopentin, administered subcutaneously, on antigen-induced proliferation of peripheral blood mononuclear cells (PBMCs) was investigated in 25 volunteers (all over 50 years of age) and in nine patients undergoing major surgery. Blood samples from another nine patients having the same type of surgery were used as control in the second trial. A statistically significant increase in the proliferative response was observed in the group of volunteers two hours after thymopentin administration. This increment was not demonstrable as significant 24 h later. In contrast to this observation, the surgical procedure-induced significant decrement in the proliferation of PBMCs observed on the first and third postoperative days did not occur in the thymopentin-treated patients on the first postoperative day. This preventive effect of the single dose of thymopentin administered two hours before surgery was no longer demonstrable on the third postoperative day. Further studies are ongoing in order to establish a treatment regimen with thymopentin for the therapy of trauma-induced immune deficiencies.

Adjuvants, Immunologic↗
PubMed1987

Thymopentine treatment improves clinical and immunological functions in aged subjects with chronic bronchitis.

The effect of in vivo thymopentine treatment (50 mg/subcutaneously every other day for six weeks) on clinical features and in vitro immunological parameters was evaluated in ten aged patients with chronic bronchitis. In vitro immunological studies were performed before and after treatment both on phenotypic (OK monoclonal defined lymphocyte subpopulations) and functional parameters (blastogenic responses to polyclonal mitogens Concanavalin-A and Phytoemagglutinine). Thymopentine did not significantly affect lymphocyte subpopulations, which were reduced before pharmacological treatment, when compared to those of young healthy controls. Peripheral blood lymphocytes blastogenic response to polyclonal mitogens was restored, even though proliferation did not reach the values of young healthy subjects. Thymopentine treatment significantly improved lymphocyte functions, without being able, however, to overcome completely the age-dependent loss of blastogenic responses. Nevertheless the favourable evolution of clinical symptoms we observed in our study may be, at least in part, related to the improvement in vivo of those immunological functions that we studied in vitro. Eight out of ten patients showed an evident improvement of symptoms and signs of chronic bronchitis after thymopentine treatment and four of them arrived to a complete remission from infectious episodes. No side effects were noted. Although still preliminary, these results seem to be encouraging as thymopentine could be used with success as an immunomodulating agent in aged people.

Adjuvants, Immunologic↗
PubMed1993

[The use of thymopentin in the prevention of recurrent infections of the respiratory system. Multicenter study].

Eighty children, between 1-12 years, suffering from recurrent respiratory infections were admitted to a multicentre study and treated with thymopentin, an immunomodulating compound that represents the active site of the natural thymic hormone thymopoietin. Thymopentin efficacy, measured as reduction in the number of infective episodes, and tolerability were assessed and, at the end of the study a global evaluation was made by each investigator. Moreover, the following factors were recorded: clinical course, duration of symptoms/signs, frequency of administration of antipyretic, antibiotic, anti-inflammatory and mucolytic therapy, school attendance and hospitalization. Thymopentin treatment resulted in a statistically significant decrease of infective recurrences. The use of symptomatic and antibiotic drugs was also reduced. Side effects were few and mild. The investigators' overall evaluation of thymopentin's efficacy and tolerability was favourable. In conclusion, thymopentin, administered subcutaneous for 5 weeks in winter, may be useful in the treatment of children with recurrent infections of the respiratory tract.

Child↗
PubMed1985

Thymopoietin to thymopentin: experimental studies.

Thymopoietin is a polypeptide hormone of the thymus consisting of 49 amino acids. The pentapeptide thymopentin (TP-5) Arg-Lys-Asp-Val-Tyr, corresponding to amino acids 32-36 of thymopoietin, appears to represent the active site of thymopoietin in that it has all the biological activities of the native hormone. Thymopoietin is secreted by epithelial cells of the thymus and is pleiotropic in action, affecting neuromuscular transmission, induction of early T cell differentiation and immune regulation. The immuno-regulatory actions of thymopentin on peripheral T cells are mediated by intracellular cyclic GMP elevations in contrast to the intracellular cyclic AMP elevations induced in precursor T cells that trigger their further differentiation to T cells. Thymopoietin and thymopentin have the biological characteristics of being immunonormalizing in a number of animal model systems of immune dysbalance. These include immune dysbalances induced by thymectomy or the thymic involution associated with aging or by other procedures in thymus-intact animals. The normalizing action of thymopentin, whether the immune dysbalance be in the direction of hyper- or hyporesponsiveness, points to its potential utility in human diseases characterized by immune dysbalance.

Animals↗
PubMed1985

Confirmative study of the effectiveness of thymopentin in active rheumatoid arthritis.

Forty-one patients with active rheumatoid arthritis entered a controlled double-blind randomized study. Of these patients, 21 received prolonged intravenous injections (10 min) of thymopentin 50 mg three times a week for 3 consecutive weeks, whereas 20 received placebo. Both groups were comparable with regard to clinical parameters. No immunological tests were performed. Analysis of the results after 3 weeks showed that the improvement in the thymopentin group was statistically significant (p less than 0.05 or p less than 0.01) for all clinical parameters, except for the left-hand grip strength. On the other hand, no significant improvement was observed for any parameter, except morning stiffness, in the patients on placebo. The intergroup comparison showed statistically significant differences, favoring thymopentin over placebo treatment, in the Ritchie index, the scores of swollen joints, the assessment of severity of pain, and the scores for changes in the activity of the disease. The present placebo-controlled double blind study thus confirms the positive results generated in a similar open study, i.e., the beneficial therapeutic effect of prolonged intravenous injections of thymopentin in patients with severe rheumatoid arthritis. The drug appears to be safe at the dose regimen used.

Adjuvants, Immunologic↗
PubMed1985

Thymopentin as adjuvant therapy to hepatitis B vaccination in formerly non-or hyporesponding hemodialysis patients.

Thirteen patients who were on chronic hemodialysis for renal failure received booster vaccination with 40 micrograms HB-Vax while receiving thymopentin as adjuvant therapy. A 50-mg dose of thymopentin was administered subcutaneously 3 times weekly for 3 weeks and vaccination was given after the first week's treatment. Seven of the 13 patients had never developed any measurable anti-HBs titers in spite of 4-5 previous vaccinations, although 6 out of these 7 had used interferon as adjuvants to their last vaccination. The remaining 6 patients were hyporesponders, but the antibodies had vanished in all before the study was started. Twelve out of the 13 patients developed anti-HBs after revaccination while on thymopentin adjuvant therapy. The antibody production started in most cases within 2 weeks after the booster HB-Vax and showed an increasing trend for up to 6 weeks. Protective titers persisted in the responder cases for the duration of the study (2-3 months). Thus thymopentin may represent a valuable tool to achieve a successful hepatitis B vaccination in hemodialysis patients.

Adjuvants, Immunologic↗
PubMed1985

Thymopentin treatment of selective IgA deficiency.

Thymic hormones have been shown to modulate immunoglobulin production in a number of experiments and it is generally agreed that this action is mediated by modulation of helper and/or suppressor T cell activities. The possibility of upregulating the immunoglobulins is of particular relevance in patients with hypogammaglobulinemias and this paper reports on the results of thymopentin treatment in 9 patients with selective IgA deficiency. Two out of 4 patients responded positively in an open-label trial; in one the serum IgA values remained stable up to 8 weeks after discontinuation of treatment whereas there was a rapid fall in the other. Both responders had consistently normal T4/T8 ratios during the treatment, whereas the nonresponders revealed high ratios with large fluctuations of the T4/T8 ratio. In a subsequent (still ongoing) double-blind trial in 5 patients (3 thymopentin, 2 placebo) no significant change of serum or secretory IgA levels has been observed. Taken together, the data suggest that the tested dose regimen of thymopentin (i.e. daily i.m. injections of 1 mg/kg for 2 weeks, then same dose 3 time weekly for 10 weeks) may only work in a subset of patients with selective IgA deficiency. In the present study we did not attempt to distinguish to which of the three known subgroups the 9 patients belonged, nor did we try alternative dose regimens of thymopentin.

Adjuvants, Immunologic↗
PubMed1985

Thymopentin: safety overview.

This paper reviews all available data on thymopentin derived from the extensive preclinical safety program; most of those studies have been concluded, only the carcinogenicity studies are nearing completion. The overview also compiles the safety parameters generated from patients treated with thymopentin for different clinical conditions; in some cases treatment lasted for 12-24 months (56 patients). Different doses and modes of administration were used. The percentage of patients with side effects was comparable to the incidences in the placebo groups. Thymopentin was also well tolerated when administered concomitantly with a long list of drugs given for other reasons. The overall conclusion in that thymopentin is a safe compound.

Animals↗
PubMed1993

Modulation of nicotinic acetylcholine receptor function in bovine adrenal chromaffin cells by thymopentin.

Thymopentin is a five amino acid peptide which corresponds to amino acids 32-36 of the thymic polypeptide thymopoietin. Previous work had shown that TP-5 could modulate responsiveness at the muscle-type nicotinic receptor. The present studies show that neuronal nicotinic receptor function, measured as radiolabelled noradrenaline release from bovine adrenal medullary cells, was attenuated by thymopentin. The pentapeptide exhibited specificity for nicotinic receptor evoked release, since thymopentin did not affect potassium-stimulated secretion of [3H]noradrenaline. It appears, therefore, that thymopentin antagonizes catecholamine release by specifically modulating nicotinic receptor responsiveness.

Acetylcholine↗
PubMed1983

Comparative efficacy of various routes of administration of thymopentin (TP-5) with consideration of degradative mechanisms.

Thymopoietin (originally termed TP-5 and now called thymopentin) is a synthetic pentapeptide that can reproduce the biological activity of the 49 amino acid thymic hormone thymopoietin. The efficacy of various routes of administration of thymopentin was studied in mice and guinea pigs using an electromyographic assay as an end point to determine biological activity. In mice, the threshold dose necessary for a significant response when compared to controls was 0.03 mg/kg (mpk) for i.v. (intravenous) injection and 0.3 mpk for both i.p. (intraperitoneal) and s.c. (subcutaneous) injection. For the guinea pig, 0.03 mpk produced a significant response when compared to controls when injected either i.v. or s.c.; 0.3 mpk was required for a significant response for i.n. (intranasal) administration and 0.6 mpk for i.p. injection. When saline or plasma was injected, it produced no change in the electromyographic response. In plasma the pentapeptide is rapidly degraded by proteolytic enzymes. Treatment of plasma with specific enzyme inhibitors followed by incubation with thymopentin or thymopoietin confirmed that serine protease and aminopeptidase M-like enzymes are responsible for the rapid inactivation of thymopentin in plasma, as measured by the electromyographic response.

Animals↗
PubMed1992

[Perioperative administration of thymopentin for the prevention of infections in oncologic surgery].

The efficacy of thymopentin in reducing postoperative infections (PI) was prospectively evaluated in 138 patients with abdominal cancer, who underwent major surgery. Comparable subsets of patients were obtained according to age (cutpoint 65 years) and nutritional status (patients with serum albumin less than 30 g/l or weight loss greater than or equal to 10% with respect to their usual body weight were considered as malnourished). Patients were then at random attributed to a control group and to a thymopentin receiving (Thy) group, in the latter thymopentin (50 mg) was given three times before surgery and three times after operation. All patients received perioperative short term antibiotic prophylaxis and postoperative parenteral nutrition. The severity of Pl was expressed by the sepsis score which was calculated on all those patients developing Pl. Overall complication rate was 26.3% in the control group and 20.3% in the Thy group (p ns). Surgical-related infections occurred in 14 (20.3%) control group patients and in 10 (14.5%) Thy group patients (p ns). The average sepsis score was 10.11 +/- 6.69 in control group (2 patients died) and 6.85 +/- 3.80 in the Thy group (all patients survived) (p less than 0.05). By considering the elderly patients, a reduction in both Pl rate and the average sepsis score was observed in Thy group. Otherwise, no difference was observed in the young patients. Our data suggest that Thymopentin is useful in reducing both the incidence and the severity of Pl in elderly patients.

Adult↗
PubMed1988

Thymopentin treatment in genital warts of long duration.

The immunomodulatory effect of thymopentin as therapy in genital warts of long duration and the proliferative responses of the patient's peripheral blood mononuclear cells were investigated in this pilot study. The observations in 6 patients suggest that subcutaneous injections of thymopentin (50 mg) beneficially influence the systems of therapy-resistant genital warts. The small number of patients and controls used in the assessment of the proliferation responses allows only a descriptive analysis of the results, but definitive trends can be observed in the Con A- and PHA-induced proliferation tests. These clinical observations, the theoretical considerations, and the low rate of side effects of thymopentin reported also by other investigators all emphasize the importance of further well-controlled double-blind studies on the treatment of genital warts with thymopentin.

Adult↗