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PubMed1985

In vitro influence of thymopentin on proliferative responses and phytohemagglutinin-induced interleukin 2 production in normal human lymphocyte cultures.

Peripheral human blood lymphocytes from healthy blood donors were investigated in vitro to observe the influence of different doses of thymopentin on nonstimulated proliferation, candidin-stimulated proliferation, and phytohemagglutinin (PHA)-induced interleukin 2 (IL2) production. Concentrations of thymopentin ranging from 0.01 to 10,000 ng/ml were used. The proliferation response in non-stimulated cultures was significantly higher in the presence of 0.01, 1, 10, 1,000, and 10,000 ng/ml of thymopentin. There was no significant increase with 0.1 or 100 ng/ml of thymopentin. Thus, three separate peaks were present in these unstimulated cultures: at a concentration of 0.01 ng/ml; between 1 and 10 ng/ml, and between 1,000 and 10,000 ng/ml. These peaks possibly represent three different subpopulations with different sensitivities to different concentrations of thymopentin. Candidin-induced proliferation was significantly higher only at concentrations of 1 and 10 ng/ml of thymopentin, corresponding to the second peak in the unstimulated culture. No other thymopentin concentrations induced significant increase in the candidin-stimulated cultures. No IL2 production was observed in the unstimulated cultures, even in the presence of thymopentin. On the contrary, preincubation with different concentrations of thymopentin influenced PHA-induced IL2 production. A significant increase in the IL2 level was observed in the supernatant of the cultures if 1,000 ng/ml of thymopentin was used in the preculture period. This concentration corresponds to the third peak in the unstimulated cultures. No significant changes were observed with other concentrations of thymopentin. As the measured value of IL2 is a result of a balance between IL2 production and utilization, the above-mentioned findings need further investigation.(ABSTRACT TRUNCATED AT 250 WORDS)

Adjuvants, Immunologic↗

PubMed1992

Maintenance of CD4+ cells by thymopentin in asymptomatic HIV-infected subjects: results of a double-blind, placebo-controlled study.

OBJECTIVE: To assess the efficacy and safety of thymopentin in HIV-infected patients who had not yet developed AIDS. DESIGN: Patients were stratified into asymptomatic or symptomatic groups and randomized to receive either thymopentin (50 mg) or placebo, subcutaneously, double-blind for 24 or 52 weeks, three times a week. SETTING: Patients were enrolled at three sites (two hospital clinics and one private practice). PATIENTS: Of 91 HIV-seropositive patients (52 asymptomatic and 39 symptomatic) from whom HIV could be isolated from peripheral blood, 45 were enrolled for 24 weeks and 46 for 52 weeks of double-blind evaluation. MAIN OUTCOME MEASURES: Virological, immunological and clinical evaluations were performed before and during treatment. RESULTS: Thymopentin-treated asymptomatic patients had more CD4+ cells, as demonstrated by a greater area under the percentage CD4+ cells curve (P = 0.03) and a shorter median time to a 20% increase in percentage of CD4+ cells (P = 0.04) in the first 24 weeks, with similar trends in the 52-week study. By 24 weeks no asymptomatic thymopentin-treated and two placebo-treated patients (9.1%, Kaplan-Meier estimate) had progressed to constitutional symptoms (P = 0.12; two-tailed Wilcoxon-Gehan test), with only one further progression in a placebo-treated patient in the subset followed for 52 weeks. Symptomatic patients receiving thymopentin or placebo were similar in both CD4+ cell levels and disease progression (two progressions to AIDS in each group). No serious adverse effects attributable to thymopentin were observed. CONCLUSIONS: These results, if confirmed, indicate that thymopentin, by maintaining CD4+ cells, could slow or arrest immune decline and consequent disease progression at the asymptomatic stage of HIV infection.

Amino Acid Sequence↗

PubMed1990

Influence of thymopentin on antibody response, and monocyte and T cell function in hemodialysis patients who fail to respond to hepatitis B vaccination.

We investigated the influence of thymopentin as an adjuvant for hepatitis B vaccination on in vitro monocyte and T cell function and in vivo antibody response in a prospective, placebo-controlled double-blind trial in 20 low- and nonresponders to hepatitis B vaccination on chronic hemodialysis. 50 mg thymopentin was given subcutaneously twice per week for 3 weeks, followed by 1 intramuscular injection of 40 micrograms HB-Vax and 3 subsequent injections of thymopentin. After 1 month, the patients were boostered with 40 micrograms HB-Vax. There was no significant difference in T cell and monocyte function after administration of thymopentin, as determined in vitro. After 3 months, 3 patients in the placebo and 2 patients in the thymopentin group had antibody titers greater than 10 U/l. In both groups only patients with normal or slightly impaired monocyte function responded to vaccination. Thus, we were not able to demonstrate a beneficial effect of thymopentin on hepatitis B vaccination in nonresponders on chronic hemodialysis. Furthermore, functional tests were not able to identify a subpopulation of uremic nonresponders who would benefit from thymopentin.

Adjuvants, Immunologic↗

PubMed1992

Acute beta-interferon or thymopentin administration increases plasma growth hormone and cortisol levels in children.

The interaction between the immune and endocrine systems has recently been investigated. Hodgkin's disease represents a model of immune disturbance frequently associated with endocrine impairment. The present study evaluated the effect of the acute administration of beta-interferon or thymopentin on plasma growth hormone, prolactin and cortisol levels in children with Hodgkin's disease (N = 8) and age- and sex-matched healthy controls (N = 8). beta-interferon (1,000,000 IU), thymopentin (50 mg) or placebo (saline) were injected after two basal blood samples (-15 and 0) and further samples were drawn at 15, 30, 45, 60, 90 and 120 min. Plasma growth hormone, prolactin and cortisol levels were measured by specific RIAs. Plasma prolactin levels did not show significant change following beta-interferon or thymopentin injection in either the controls or the patients. In the patients with Hodgkin's disease, beta-interferon injection induced a significant increase in both plasma growth hormone and cortisol levels, while thymopentin was not effective. In controls both thymopentin and beta-interferon administration increased plasma growth hormone and cortisol levels. These results indicate that beta-interferon and thymopentin are immune substances active on the release of growth hormone and cortisol in healthy children. The lack of effect of thymopentin in children with Hodgkin's disease suggests an impairment of the immune-endocrine interaction in these patients.

Adolescent↗

PubMed1985

Prevention of recurrences in frequently relapsing herpes labialis with thymopentin. A randomized double-blind placebo-controlled multicenter study.

The present randomized, placebo-controlled double-blind multicenter study included a population of 36 subjects with frequent recurrences (at least once a month) of herpes labialis. Most of the patients had failed to respond adequately to previous treatment with other therapeutic tools, including acyclovir. Either 50 mg of thymopentin or of placebo was administered 3 times a week, by the subcutaneous route, for 6 weeks. Subsequently, the patients were observed for nearly 6 months on the average. The results achieved with thymopentin for the individual parameters were significantly superior to those obtained with placebo; thus significant improvement was seen in patients on thymopentin in the duration of the longest symptomfree period (prolonged from 2.1 weeks to 20.9 weeks, p = 0.000), in the number of relapses (reduced from 1.6 to 0.4 episodes/month, p = 0.001), and in the total duration of herpes symptoms per month (shortened from 2.0 to 0.3 weeks, p = 0.000). Placebo treatment also resulted in considerable improvement (p less than 0.05 or 0.01), but was significantly inferior to the improvement obtained with thymopentin. The longest symptomfree period in the placebo group was prolonged from 2.4 to 11.2 weeks. The number of relapses per month was reduced from 1.4 to 0.8, and the total duration of herpes symptoms per month from 2 to 0.9 weeks. The results of intergroup analyses, in which the observed parameters and the improvement achieved in either group were compared, significantly favored thymopentin treatment. The effect of thymopentin was in all but one parameters superior to that of placebo and highly significant (p less than 0.01).

Adjuvants, Immunologic↗

PubMed1990

Thymopentin therapy reduces the clinical severity of atopic dermatitis.

One hundred patients with moderate to severe atopic dermatitis were entered into a two-center, double-blind trial. Patients were randomized to receive either thymopentin (Timunox, n = 48) or placebo (n = 52), administered as daily subcutaneous injections for 6 weeks. Clinical extent of disease and severity parameters were measured at baseline and at regular time intervals during the study. Both the placebo- and thymopentin-treated groups demonstrated a progressive and statistically significant (p less than 0.001) decline in the overall severity of their disease, but reduction in the clinical severity score was higher in the thymopentin-treated group and statistically significant (p = 0.04) in comparison with the placebo-treated group after 6 weeks of treatment. Of the individual symptoms comprising the total severity score, pruritus (p = 0.02) and erythema (p = 0.04) were reduced significantly when thymopentin therapy was compared to placebo therapy. In addition, both the extent of body involvement and severity index (a combined severity/extent index) were significantly reduced after 6 weeks in the thymopentin-treated group in comparison to the placebo-treated group (p = 0.04). There were no serious adverse experiences in either treatment group. We conclude that treatment with thymopentin is safe and offers significant therapeutic promise for atopic dermatitis.

Adolescent↗

PubMed1990

Thymopentin antagonizes stress-induced changes of GABA/benzodiazepine receptor complex.

Intraperitoneal administration of thymopentin, a thymopentin II-derived pentapeptide, had no stable and evident effect in the two anxiety models (elevated plus-maze and licking-conflict test) studied. However, in the elevated plus-maze test thymopentin antagonized the behavioral effects of DMCM, a beta-carboline derivative with anxiogenic properties. Further, it was demonstrated that the licking-conflict test procedure itself produced a significant elevation of plasma corticosterone levels, increased the number of [3H]flunitrazepam and decreased the number of [3H]muscimol binding sites in rat hippocampus. The forced-swimming stress similarly to the licking-conflict test also caused an increase in hippocampal [3H]flunitrazepam binding sites. Although ineffective behaviorally in the tests for anxiety, thymopentin pretreatment effectively reversed the changes in corticosterone levels caused by the licking-conflict test. Moreover, it normalized the changed number of benzodiazepine and GABA receptors after stressful stimuli. It is well known that not all anxiolytic drugs (i.e. buspirone) are equally active in behavioral tests for anxiety. According to our data we propose that thymopentin has stress-protective activity. As in vivo and in vitro thymopentin did not change [3H]-flunitrazepam and [3H]muscimol binding, the direct effect of this peptide on the GABA-benzodiazepine-Cl- ionophore receptor complex is unlikely. The action of this peptide on GABA release and/or metabolism can be suggested.

Animals↗

PubMed1992

Thymopentin treatment in severe atopic dermatitis--clinical and immunological evaluations.

An open clinical trial of thymopentin was conducted on 16 children with severe atopic dermatitis. The patients were treated with injections three times a week of 50 mg thymopentin for six weeks. They were then divided randomly into two groups: group A continued thymopentin for an additional six weeks, and group B were treated with normal saline. Clinical parameters and immunological function were evaluated serially. The total severity score started to decline from baseline significantly three weeks after treatment, and continued throughout the study period in group A but began to flare up in group B two weeks after stopping thymopentin. All the eight patients in group A completed the trial but three out of eight in group B dropped out because of flaring up of skin lesion. In vitro production of interleukin-4 tended to decrease and that of interferon gamma tended to increase, but total serum IgE, in vitro IgE synthesis, and abnormally low CD8+ CD11b+ suppressor T cells remained unchanged. Histamine releasing factor (HRF), plasma histamine, and respiratory burst activities of polymorphonuclear leucocytes were appreciably decreased after thymopentin treatment. It is concluded that the clinical efficacy of short term thymopentin treatment very possibly results from the decreased production of HRF and decreased release of polymorphonuclear leucocyte derived inflammatory mediators and may have no relation with antigen-IgE immune reaction.

Adolescent↗

PubMed1985

Effect of thymopentin on the mortality and immune response after an experimental herpes simplex infection in mice.

The effect of thymopentin on the mortality rate of mice treated with lethal doses (LD90) of herpes virus 2 and on the cytotoxic T cell activity after sublethal doses (LD10) of herpes virus was investigated in two series of experiments. Doses of 1, 0.1 or 0.01 ng of thymopentin per g/mouse were administered i.p. in each experiment, either 3 days before, 3 days (66 h) after, or 3 and 6 days after the herpes virus infection. The cumulative mortality rate was evaluated 10 days after the infection. Cytotoxic T cell activity was measured 3, 7 and 14 days after the infection. The 0.1-ng dose of thymopentin reduced the mortality rate to less than 50% (p = 0.0000) if it was administered 3 days before the infection. A single injection of any dose after infection did not reduce the mortality at all, while two injections of 0.1 ng reduced it by about 25% (p = 0.0038). A 1-ng dose showed a mild but significant reduction (p = 0.0313) if it was applied 3 days before the infection. The cytotoxic T cell activity was either not influenced or significantly modified (p less than 0.05), i.e. increased or decreased as compared to the control, depending on the dose and timing of thymopentin. A correlation between increased cytotoxic T cell activity and protection against mortality can be demonstrated, while no protection was observed in dose regimens where the cytotoxic T cell activity became reduced. The results are discussed in connection with earlier clinical studies in which the beneficial effect of thymopentin has been demonstrated in frequently relapsing herpes labialis and herpes genitalis patients.

Adjuvants, Immunologic↗

PubMed1985

Thymopentin treatment in AIDS and pre-AIDS patients.

Three pilot studies testing thymopentin in AIDS patients are presented. One study included 5 patients with the full-blown syndrome, all treated with 50 mg thymopentin 3 times a week by intravenous slow infusion; no immunologically nor clinically positive results were observed, indicating that the T cell pool in such patients is severely depleted. Six other patients with the prodromal stage of AIDS were treated 1 month with 50 mg thymopentin administered as an intravenous bolus injection 3 times weekly and thereafter for another month with same dose regimen as intravenous slow infusions. The patients on infusion therapy experienced statistically significant immunological improvements; these positive findings were paralleled with an improvement of the patients' clinical condition. These positive responses persisted for an average of 8 months. In another group of 5 pre-AIDS patients thymopentin was administered via the subcutaneous route using 15 mg 3 times weekly; only 1 patient revealed immunological and clinical improvement. In summary, only patients with the pre-AIDS syndrome are likely to benefit from immunomodulation therapy with thymopentin, and the mode of administration seems to be crucial.

Acquired Immunodeficiency Syndrome↗

PubMed1990

An aminoboronic acid derivative inhibits thymopentin metabolism by mucosal membrane aminopeptidases.

Thymopentin is a pentapeptide with immunomodulatory activity. Transmucosal delivery may offer advantages over other routes, but published data have shown relatively poor efficacy when dosed nasally. Metabolism of thymopentin by the rat nasal mucosa and the effects of an aminoboronic acid aminopeptidase inhibitor, boroleucine, were evaluated. Thymopentin concentrations in a solution perfused through the isolated nasal cavity decayed with a first-order half-life of 12 minutes. Thymopentin was metabolized primarily by aminopeptidases, based on the amount of tetrapeptide metabolite formed. In the presence of boroleucine, at an inhibitor/substrate molar concentration ratio of 0.015/1, the degradation half-life was prolonged to 37 minutes. Appearance of the tetrapeptide metabolite of aminopeptidases was delayed. Boroleucine and other aminoboronic acid peptidase inhibitors may be useful for improving thymopentin delivery.

Amino Acid Sequence↗

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↗

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↗

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↗