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Clinical researches

The OYOX study, conducted by DANDA Pharma under the supervision of PhD Wolfgang Shatton, was initiated by the Institute of Theoretical and Experimental Biophysics (Russian Academy of Sciences) and monitored by the Biological Systems Energy Laboratory.
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Preliminary research phase

Purpose

The study of telomere length as a genetic indicator of age-related disorders.

General information

Number of examined: 1780 people; Average age: 59 years; Observation period: 28 months;

Conclusions

In leukocytes of peripheral blood in patients with a short long telomere corresponding to the lower 7 percent of the distribution, the probability of cancer is 27% higher than in other patients with longer telomeres. Values of aging markers were noted 62% higher in the group with short telomeres corresponding to the lower 12 percent of the distribution than in patients with longer telomeres.

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Multicenter open randomized trial of the efficacy and reliability of clinical effects, safety, immunogenicity of OYOX in humans according to the protocol of voluntary trials. Natural activator SIRT1; SIRT3; SIRT6 as part of a health program.

Purpose

To evaluate the clinical effects of OYOX

General information

The length of telomeres and other biological indicators of the aging process were determined (blood test with a leukocyte formula, the condition and functioning of the immune system, the condition of the kidneys, liver, endocrine system, cholesterol, glucose metabolism, the state of the cardiovascular system, bones, skin, eyesight)

52% of participants took OYOX, 48% took placebo

The initial evaluation of the obtained clinical data was carried out by experts, the final data analysis was additionally processed using artificial intelligence - the ATECH neural network- in order to identify the deep relationships of the monitored parameters.

Evaluation was performed before the start of the study and after 1, 3, 6, and 12 months after taking OYOX

980 people, age range 30-87 years; 58% men, 42% women

Before taking After 2 months
Row 1 Row 2 Row 3 Row 4
m f m f sex
42-68 40-53 42-68 40-53 age
5,4 5,3 9,2 8,9 telomere length measurement, kb
7,7 7,7 9,4 11,2 RTL Index
4,8 4,5 4,1 3,8 CRP, mg /l
6,23 5,9 4,8 5 Total cholesterol, mmol/l
3,3 2,8 2,2 1,7 LDL, mmol/l
0,7 0,9 1,5 1,8 HDL, mmol/l
5,6 5,4 4,9 5 glycosylated hemoglobin (HbA1c,%)
94 94 88 76 creatinine (NKF, 2001), μmol/L
9,3 12 7,9 9 total bilirubin, mmol/l
22 19 18 17 ALT Unit/L
19 19 16 18 AST Unit/L
Average values are given
OYOX Placebo
Before taking After 3 months Before taking After 3 months
Row 1 Row 2 Row 3 Row 4 Row 5 Row 6 Row 7 Row 8
m f m f m f m f sex
45-67 42-59 45-67 42-59 46-66 43-54 46-66 43-54 age
4,4 5,4 10,1 9,4 4,8 4,7 4,8 4,5 telomere length measurement, kb
7,3 8,4 12 11,8 7,9 8,2 6,2 7,9 RTL Index
4,3 4,8 3 2,9 4,4 4,9 4,5 4,8 CRP, mg /l
5,2 5 4,8 4,6 5 4,6 5,3 4,9 Total cholesterol, mmol/l
2,8 3,1 2 2,2 2 2,4 2 2,3 LDL, mmol/l
0,7 1 1,5 1,7 0,9 1,9 1 1,9 HDL, mmol/l
5,8 5,7 4,6 5,1 5,9 5,6 5,8 5,8 glycosylated hemoglobin (HbA1c,%)
98 96 80 77 98 105 100 101 creatinine (NKF, 2001), μmol/L
10,8 12,2 9,6 9,8 11,3 11,9 11,2 11,5 total bilirubin, mmol/l
23 26 20 19,2 28 31 28 31 ALT Unit/L
29 30 28 20 23 28 24 27 AST Unit/L
Average values are given
OYOX Placebo
Before taking After 6 months Before taking After 6 months
Row 1 Row 2 Row 3 Row 4 Row 5 Row 6 Row 7 Row 8
m f m f m f m f sex
45-67 42-59 45-67 42-59 46-66 43-54 46-66 43-54 age
7,9 8,1 12,3 10,4 7,3 7,9 7,5 7,2 telomere length measurement, kb
10,4 11,5 15,4 13,3 8,2 9,4 9 8,3 RTL Index
4,2 4,1 2,5 2,9 4,3 3,8 5,4 2,6 CRP, mg /l
5,4 5,8 4,8 5 5,9 4,9 6 5,4 Total cholesterol, mmol/l
2,8 2,6 2 1,8 2,8 1,9 3 1,8 LDL, mmol/l
1,3 1,4 2 1,8 1,5 1,6 1,4 1,3 HDL, mmol/l
5,8 5,6 4,9 5 5,3 5,9 5,5 5,4 glycosylated hemoglobin (HbA1c,%)
100 98 90 85 112 99 111 102 creatinine (NKF, 2001), μmol/L
12,8 10,7 10,2 9,4 11,6 10,9 11,8 10,2 total bilirubin, mmol/l
25 19 22 16 22 28 23 27 ALT Unit/L
22 21 19,5 20 25 26,7 25,2 27,1 AST Unit/L
Average values are given

Results

In the group of people taking OYOX, it was reliably noted:

- Statistically significant decrease in the percentage of short telomeres (p = 0.029).

- Decrease in the percentage of aging cytotoxic (CD8+/CD28-) T-cells (1.5%; 4.4%; 8.6% and 7.5% after 1, 3.6 and 12 months).

- Improvement of lipid and carbohydrate metabolism, glycosylated hemoglobin (HbA 1%) 4.9% (p = 0.01), total cholesterol 5.7 mmol / l (p = 0.003) low density lipoproteins (LCL-C) - 3, 82 mmol / L (p = 0.0021) homocysteine-3.4 mmol / L (p = 0.001) For the reduced systolic and diastolic blood pressure, the dynamics was 17.1-4.2 mm Hg. (p = 0.006 and 0.002, respectively).

- After 8 months, bone mineral density increased by 2% (p=0.002).

- OYOX was not associated with the development of side effects.

Conclusions

Participants in the study taking OYOX also reported other beneficial effects, such as improved vision, sexual function, increased energy and stamina, flexibility, mental acuity, and normalization of weight. In addition, they reported a decrease in the appearance of age-related age spots and an improvement in the general condition of the skin, hair, and nails, which requires additional research.

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A laboratory research to study the increase in the antiviral function of human CD8 + T-lymphocytes as a result of a pharmacological increase in the level of sirtuins

Purpose

To study the effect of the CYC-8 molecule (a key component of OYOX) on mononuclear peripheral cells (MNPC) and CD8 T lymphocytes.

General information

Selected cells MNPK and CD8 T-lymphocytes of patients of the age group from 30-92 years old were exposed to the drug based on CYC-8 molecule. 72 hours after the initial stimulation, sirtuin activity in the samples was measured. As a second stimulation, this process was repeated after 18 days.

Results

1. The “CYC-8” stimulated effect of increased activity of sirtuins in MNPKs of donors of the age group of 30-35 years was relatively moderate in the range from 1.5 to 2.5 times. "CYC-8" significantly increased the activity of sirtuins in MNPKs of the age group 36-55 years from 3.5 to 7 times. In the age group of 57-87 years, the activity of sirtuins increased from 2.5 times -14 times.

2. Within a few minutes after contact with CYC-8, the MAPK/ERK pathway is activated, followed by an increase in the production of SIRT1 gene sirtuins; 3; 6 (with a maximum of 12 hours) of activation reaches a maximum after 16-48 hours.

3. A short 7-day exposure of “CYC-8” to CD4 + CD8 + T-lymphocytes led to a small, but statistically significant increase in the number of doubling of the population compared to control untreated cells.

4. As a result of the work, no evidence was obtained that the use of “CYC-8” contributed to the loss of growth control and transformation in the culture of the studied cells. Moreover, “CYC-8” does not lead to any significant increase in the constitutive activity of sirtuins in a healthy young age group of 22-28 years.

5. An increase in the cytobiochemical marker of the number and activity of mitochondria in peripheral blood lymphocytes was found, which confirms the realization of increased activity of sirtuins 1,3,6 at the level of mitochondriogenesis.

Conclusions

OYOX represents a new class of prophylactic and therapeutic agents that improve the condition of the immune system by affecting various levels of organization from the cellular and tissue to the neuro-endocrine-immune megasystem of the body, slowing aging, thereby prolonging active healthy longevity.

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First experience with OYOX in patients with COVID-19 complicated by pneumonia for the prevention of interstitial pulmonary fibrosis and long-term effects

Relevance of the problem

One of the key factors in the development of COVID-19 disease caused by the SARS-CoV-2 virus is a change in the cytokine profile in virus-induced pneumonia, which is significantly superior to bacterial community-acquired pneumonia. The most pronounced overproduction of anti-inflammatory cytokines (IFNy, TNFa), tissue factor inhibitor (TFPI) and pathological activation marker of endothelium (sICAM-1) indicate an unbalanced immune response of the body and, as a result, this threatens the development of interstitial pulmonary fibrosis in moderate to severe scenarios course of the disease. The potential therapeutic effect for a balanced and effective response of the body during the convalescence of patients with COVID-19 allowed the inclusion of OYOX to eliminate sirtuin deficiency and protect DNA during transcription from damage. These two key mechanisms of action of OYOX enable the correct molecular synthesis and restoration of self-regulatory systems of the body as a whole.

Purpose

To study the effect of OYOX in preventing the development of interstitial pulmonary fibrosis and the long-term effects of viral pneumonia with changes in the cytokine profile in patients with COVID-19. To evaluate the dynamics and timing of lung tissue recovery after a previous COVID-19 infection while taking OYOX.

General information

Patients during the epidemic rise of COVID-19 in the clinical recovery phase. Design of a clinical study of the effectiveness of OYOX in the rehabilitation of patients undergoing COVID-19 complicated by pneumonia and changes in the cytokine profile: prospective, open, comparative. The control group was not formed for ethical reasons. In order to compare groups according to the main criteria of effectiveness, the case histories of 30 patients not receiving OYOX during the convalescence period were analyzed. All patients underwent symptomatic therapy. The study was carried out in accordance with the ethical standards provided for by the Declaration of the XVIII World Medical Assembly (Helsinki June1964).

The group that took the OYOX course during the convalescence period included the following participants:
- with a confirmed diagnosis of COVID-19;
- with CT criteria of the bilateral pneumonia with focuses of lung tissue compaction and involvement of the parenchyma in the pathological process;
- with determination of the concentration of immunoglobulins (IgA, IgM, IgG and IgG subclasses), cytokines (IL-1b, IL-8, IL-10) in the bloodserum.

Results

An analysis of the obtained objective data and dynamic monitoring of the general well-being of the patients suggest that OYOX is highly effective in the rehabilitation of patients with COVID-19.

After 30 days of taking OYOX:
- biochemical blood parameters within the age norm;
- restoration of tissue respiration - saturation 98-99;
- when conducting computer tomography of the chest, focal changes and compaction of the lung tissue are absent.

Conclusions

Evaluation of the effectiveness of OYOX was established when the pulmonary pattern was completely restored after the virus-induced pneumonia, and the absence of pathological compaction of the lung tissue (confirmed by a CT scan of the chest organs) positive dynamics and normalization of biochemical laboratory parameters of blood and immune status significant improvement in well-being and disability recovery.

The use of OYOX in the rehabilitation of patients undergoing COVID-19 complicated by pneumonia and changes in the cytokine profile has convincingly shown a reduction in rehabilitation time. Participants taking OYOX noted a significant improvement in well-being, normalization of sleep, the absence of signs of fatigue already at 7-10 days from the start of treatment. Positive dynamics of the restoration of pulmonary pattern during CT-scan was observed on the 12th day after taking OYOX.