The results of a complete study with Statistic Thymic Peptides GKL-02 examined on seven patients with cancerous tumors are finished

Summary of the results of the studies carried out

The results of the stimulation of the cytokines on 3 healthy subjects to establish the methodology already showed that an increase in cytokine expression could be found with the agent GKL02 200 µg/ml and 20 µg/ml following prestimulation with ConA/SEB.

These were healthy patients, in this respect an increase in cytokine expression could be found in all the subjects for the cytokines IL-2, IL-10, IFN- and TNF- compared to the patients examined in the study.

In the cases of IL-17 and IL-4 there were already different cytokine inductions, depending on the initial condition. This shows the different individual reactability of the immune response to the stimulation of differently acting cytokines even in healthy patients (see text p. 8, Fig. p. 9 and p. 10).

The reactions of the cytokines following prestimulation in 10 oncological patients with metastasising cancers or high-risk illnesses, and a patient with fibromyalgia syndrome were then studied in accordance with step 2, p. 6.

Individual trends of the measurement results for the individual patients are shown, which are reproduced in detail on pp. 13-20.

In summary, the trend shows that the agent GKL02 200 µg/ml effects a regulation of excessive cytokine concentrations and a stimulation of lower concentrations.

The figures showing the individual results for TNF-, IFN-, IL-10 and IL-17 show that although the reactions of the cytokine secretion after incubation with 200 µg/ml and 20 µg/ml of the agent are very different, they can be interpreted well individually with the clinical situation of the patients.

Characteristically, in a patient who was overstimulated both in the cytokine pattern and in the T-cell immune response (F.E.), all cytokines are downregulated by GKL02 (see pp. 13-20, trend graphs in Fig. 2-7 and cytokine tables 4-5).

In contrast, in one patient with a cellular immunodeficiency which could not be therapeutically influenced for years, the stimulation of all the cytokines occurred with GKL02 at a low dose.

In summary, a change in the cytokine profile which is differentiated depending on the individually immunologically existing initial situation and clinical status of the patient takes place for the agent GKL02 200µg/ml, in some cases also 20 µg/ml. Overstimulation of TNF-, IFN-, IL-2, IL-10 and IL-17 is downregulated, deficient cytokine levels are stimulated.

The very different results of the stimulation or suppression of the measured cytokines can be seen in overview in the bar charts of pp. 21-26.

In the subsequent detailed evaluations on pp.27-101 of the results of the patients, 4 of the treated patients (A.G., B.H., E.V., W.H.) showed a very differentiated response to the cytokine stimulation. In the measurement of the cellular immune parameters, the cellular immune response was improved. Regulatory effects could in particular be found, which are described in detail in the analyses of the individual patients. The results corresponded with the clinical situation of the patients in that deficient situations could be improved but also overstimulation could be downregulated.

The improvement of the cellular immune parameters in patient G.A., who was however in an exceptionally favourable immunological initial situation owing to previous immunotherapies for his metastasising cancer, was noticeable.

Patient B.H., who had suffered from an untreatable leucopoenia and lymphocytopoenia for many years, showed an impressive improvement in his overall T-cell situation.

In Patient E.V., a chronic inflammatory situation due to an interference field was very positively affected in the end, but with inclusion of other measures necessary for treating the interference field. A continuous impressive improvement in his PSA situation (see Fig. 8, p. 69) and a clinical improvement in his interference field symptoms then occurred without tumour-destructive measures.

In B.H. and F.E. overstimulation of the cellular immune response was downregulated. Both patients are symptom-free after almost one year of follow-up checks.

In summary, the study showed that the tested agent GKL02 200 µg/ml, but also 20µg/ml, is a potent immunomodulator which is suitable for modulating T-cell function disorders with corresponding cytokine and immune diagnostics.

It should now be shown in clinical studies how quality of life and survival time can be improved by corresponding correction of the T-cell defence, in particular modulation of excessive immune responses, influencing chronic inflammation, but also stimulation of NK cells and cytotoxic lymphocytes.

Summary and assessment

In the present analysis, it was possible to show that a defined statistic thymic peptide library has regulatory effects on cytokine patterns and consequently on T-cell defence functions. An adapted modulation of the T-cell immune response occurs depending on the individual immune situation and the clinical symptoms, which also depends on the genetic predisposition of each individual patient (“low” vs. “high” responder).

Corresponding effects can be found both in vitro and after treatment in accordance with the individual initial situation.

As a result, the immune situation of oncological patients is improved. Overall, the result for the agent was a modulating effect on both cytokine patterns and phenotypic index markers for the cellular immune function