Report on Flaraxin clinical trial (II extended phase) 
 
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REPORT on the results of clinical trials of new anticancer drug FLARAXIN /2 extended phase of research/ Oncology Department of Crimea State Medical Oncology Department of Crimea State Medical University named after S. I. GeorgievskySimferopol 2000
Research was conducted in the period from May 1998 till September 2000
 
 
 
Executors: Chief of the III Oncological Department (mammary gland cancer) of CSMU d.m.s, professor – A.G.Filenko
Chief of the Radiological Department (cervical cancer) of CSMU d.m.s., professor – N.I.Verizhnikova
Chief of the II Oncological Department (melanoblastoma) of CSMU d.m.s., professor – I.V.Pohvalin
Rector: of the Crimea State Medical University (CSMU) named after S. I. Georgievsky MD, professor - A.A.Babanin
Leader: Chairman of the Oncology Department of the Crimea State Medical University (CSMU)  named after S. I. Georgievsky MD, professor – V.M.Efetov
Responsible Executor: Assistant of the Oncology Department (lungs cancer) of CSMU named after S.I.Georgievsky d.m.s, professor – A.V.Protsenko
 
 
 
Summary

Report about Clinical Trial of comparable treatment efficiency and tolerance of the FLARAXIN drug produced by Scientific and Treatment Center for Cancer Curing PHOENIX Ltd. with base therapy and written on 30 pages of typed document and contains 6 tables and 43 sources of literature.

The drug "FLARAXIN" is a light yellow or brownish-yellow lyophilized powder or porous mass, the following composition (active substance in the vial to 0,15 g): a based substance for FLARAXIN from 0,10 to 0,11 and the other components of 0,03 to 0,05.

According to preclinical studies of the drug was found that "FLARAXIN" is a remedy of plant origin active components of which are plant Polyphenols. The study found that "FLARAXIN" has the ability to stimulate endogenous interferon and tumor necrosis factor contributes to the normalization of the immunological background and equalizes the ratio of immunocompetent cells CD4/CD8 (helper-suppressor) and increases the number of natural killer (NK-cells).

During accomplishment of immuno-biochemical studies has been established the ability of "FLARAXIN" to bound onco-fetal proteins, causing their micro-denaturation damage. Carcinostatic effect is explained by the influence of "FLARAXIN" on the metabolism of tumor cells, causing their death. Based on these preclinical and Phase II clinical trial of the drug "FLARAXIN" we can conclude that it belongs to a group of almost harmless and non-toxic drugs, and does not have allergic and locally irritating effect, except cases of individual hypersensitivity to the drug "FLARAXIN".

The study was conducted on 304 patients - with lung cancer stages III and IV; Breast Cancer II, III and IV stage, cervical cancer I, II, III, IV stage, melanoma.

Accomplished clinical and bacteriological studies have shown that the drug "FLARAXIN, used intravenously, has significant antitumor, immunomodulating, and antioxidant action, thereby significantly affecting the quality and thus increasing life expectancy of cancer patients, especially in the early stages - I, II, III and some cases of IV stages of cancer process.

There was no case of intolerance to the drug “FLARAXIN”.

 

Content of the Report
1. Ethical and legal standards of research; instruction of the patients;
1.1. Researchers and administrative structure of the study (the characteristic of clinical database).
2. Introduction
2.1. Ground of the study.
2.1.1. Theoretical assumptions
2.1.2.      Experimental data and preliminary clinical study of the drug.
2.2.        The Aim and objectives of the study.
 
The overall study design.
3.1.        Type of the study.
3.2.        General description of the study.
3.3.        Stages of the study.
 
The investigated drug:
4.1.        General characteristics of FLARAXIN;
4.2.        Comparison with the basic therapy.
Selection of the patients for the study: rationale formed comparison of groups, criteria for inclusion of patients and control group.
Scheme investigation of the patients.
6.1.        Investigation Methods of patients general status, Criteria for the evaluation of Cancer process flow
 
Methods of treatment.
7.1.        Data on previous treatment of patients
7.2.        The main treatment by the investigated drug;
7.3.        Concomitant therapy.
Criteria for evaluation of the treatment efficiency and tolerability of the drug.

8.1.        Clinical and laboratory parameters of the Cancer process changes
8.2.        Criteria for the evaluation of patient general state in dynamics.
Evaluation of the treatment efficiency.

9.1.        General characteristics of patients in groups;
9.2.        Evaluation of the direction flow for the Cancer process
9.3.        Dynamics of the patient’s general condition index in experimental and control groups.
10. Evaluation of the experimental drug Flaraxin on tolerability, on allergic and local irritating action, on   general and side (toxic) reactions.
Discussion of the results and main conclusions.
The list of literature.
 
 1. Ethical and legal standards of research; instruction of the patients.
This clinical trial was conducted in accordance with the Law of Ukraine "On Medicines", p.7, 8, and the principles of the Helsinki Declaration.
This study was initiated after the approval of the clinical trial protocol by the Commission on the Ethics of the Pharmacological Committee of Health Ministry of Ukraine.
Patients who are potential participants in the trial were informed about the character of clinical trials, investigated drug, as well as the possible risk associated with drug intake by "information sheet for the patients".
All patients included in the study signed a written agreement with aim to participate in clinical trial.
All documentation related to the study, as well as information concerning the patients who participated in the clinical trial are strictly confidential.
1.1.   Researchers and administrative structure of the study (the characteristic of clinical database).

The General Executor - Crimea State Medical University named after S. I. Georgievsky, Simferopol (Rector - prof. Academician Babanin A.A.)
Address: 5/7 Boulevard Lenin, 95006-Simferopol, Crimea, Ukraine.
Phone: +38-067-6433202
Fax:     +38-064-2504908
 
Department of Oncology - (Chairman of the Oncology Department - MD, Professor Efetov V.M.) on the basis of the Crimean Republican Clinical Oncology Dispensary
Address: 49a Bespalova st., Simferopol, Crimea, Ukraine.
Tel: +38 0652 23-23-78 - Department
      +38 0652 23-23-72 - office
      +38 0652 25-57-35 - home
 
Crimean Republican Clinical Cancer Center presented many oncology departments:
I-Gynecological Department,
II-Surgery,
III-Chemotherapeutic Department
IV-Proctologic Department
V-Thoracic Department
VI-Radiology Department
VII-Hematological Department
 
The clinic has cabinets’ ultrasound, gastroscopy, bronchoscopy, radiological investigations and laboratory - clinical, biochemical, bacteriological, histological and pathologic-morphological.
2. Introduction.

2.1. Ground of the study.
At the present level of medical science development still remain topical issues of cancer treatment. Statistics in recent years shows that in developed countries the diagnosis of cancer "or" malignant neoplasm" is placed around one in three people over their lifetime, and about one in four dying because of cancer.
As a result of the Chernobyl disaster that happened 26 April 1986 in extended territories of Ukraine, Belarus and Russia was created conditions of permanent contamination of the environment with wide range of radionuclides, that are continuing to came, till this days, to the human body with food, water and breathable air.
The most serious of all consequences of radiation exposure on the human organism is cancer. Based on years of experience, using the available observations over large continents (about a hundred thousand people), survivors of the atomic bombings of Hiroshima and Nagasaki in 1945, showed that cancer was the sole cause of mortality in this population. Domestic authors note that patients with chronic, primarily domestic and short-term external exposure is increased the number of leukemia and stomach cancer, to a lesser extent - a tumor of urinary tract, brain, esophagus, cervix. The duration of a clear manifestation of the radiation effect of the tumor was found to be approximately 25-30 years. Note that ionizing radiation can also have influence on the potential tumor cells, i.e., on those cells that can be a source for malignant tumors, contributing to the degeneration of these cells and the development of cancer diseases.
 
2.1.1. The theoretical assumptions.
It is known that treatment of tumors, despite to the enormous long-term efforts of scientists around the world, still remains largely unsolved problem. The Used methods, among which are essential, along with surgery is chemotherapy, alone or in combination with radiotherapy and radiotherapy, are often not sufficiently effective. In addition, all these effects by themselves cause immunosuppression, which leads to suppression of the medullary hematopoiesis and infectious complications, as well as the development of intestinal dysbiosis. As a result of tumor development the immune system is going down and radiation is another extra stroke that suppressing its activity. It follows thence that successful treatment of tumors may depend on the balance between antitumor efficiency of chemotherapeutic drugs and the potential of the immune system, adequate (or inadequate) to cope with the remaining amount of tumor cells that stays after the treatment.
The foregoing leaves no doubt that the immune system is in the Centrum of the ongoing attempts to improve the efficiency of anticancer therapy, and main task is to activate the antitumor potential of the immune system and this is the most important task in modern oncology. Therefore, any attempt to weaken the side (immunosuppressive) effects of chemotherapy and Radiotherapy are unquestionably valid.
 
2.1.2. Experimental data and preliminary clinical study of the drug.
Taking into account information on STCCC "Phoenix", Flaraxin drug was developed, which is a remedy of plant origin with active components of plant Polyphenols. The ability of FLARAXIN to stimulate endogenous interferon and tumor necrosis factor was proved, also FLARAXIN contributes to the normalization of the immunological background and equalizes the ratio of immunocompetent cells CD4/CD8 (helper-suppressor) and increases the number of natural killer (NK-cells).
After FLARAXIN injection by the immuno-bio-chemical research has been find out that drug has ability to bind with onco-fetal proteins, causing their micro denaturation damage. Carcinostatic effect is explained by the FLARAXIN influence on the metabolism of tumor cells, causing their death.
 
2.2. The Aim and objectives of the study.
The aim of this study - a clinical trial on comparative efficiency and tolerability of FLARAXIN, lyophilized powder, the production company of STCCC "Phoenix" for cancer treatment.
 
Tasks of the study:
1.      To evaluate the antitumor effect of the drug "FLARAXIN in patients with breast cancer, cervical cancer, lung cancer and melanoma;
2.      To conduct the comparative evaluation of clinical efficiency of "FLARAXIN" produced by STCCC "Phoenix" and the basic therapy;
3.      To assess the tolerability of "FLARAXIN";
4.      Identify the possible adverse effect of the drug "FLARAXIN" on clinical and laboratory indices.
3. General characteristics of FLARAXIN.
Type of research. General description of research. Stages of research.
An open randomized comparative study of the II extended phase of clinical trial of the drug "FLARAXIN" was carry out. The study was conducted on 300 patients, undergoing at a hospital treatment and the appropriate criteria of inclusion/exclusion was taken in to account and will be listed below.
The relevant criteria for inclusion in the trial (development) patients give written consent to participate after referring and singing "information sheet for patients".
Randomized distribution of patients participated in the clinical trial of the main (210 patients) and control (90 patients) groups performed using the method of random numbers.
Prescription of the drug, timing interval and method of its application, the character of the concurrent therapy, clinical and laboratory data for monitoring the effectiveness and tolerability of the drug were evaluated on the proposed scale, statistically analysed for a comparative evaluation of treatment of investigated and control groups.
4. The investigated drug: general characteristics of FLARAXIN; Comparison with the basic therapy.
The experimental drug is "FLARAXIN" produced by STCCC "Phoenix" Ltd, Kharkov. As a comparative therapy was used radiation therapy and chemotherapeutic drugs therapy.
Content of the drug “Flaraxin”

Base substance of "FLARAXIN"

75%

0,1125 g

Other components of “FLARAXIN”

25%

0, 0375 g

 
The choice of comparative treatment justified: radiation therapy and chemotherapeutic drugs therapy is comparable with investigated drug on the effect on the life quality and life duration of cancer patients.

5. Selection of the patients for the study. Rationale formed comparison of groups, criteria for inclusion of patients and control group.

Selection of the patients accordingly to the requirements of the Protocol on Clinical trials based on inclusion/exclusion criteria in the groups under investigation.

Inclusion criteria

·        Men and women;
·        Age of patients: from 18 till 80 years;
·        Patients with the cancer presence;
·        Patient consent;
·        Adequate patients ability to cooperate during treatment process;
Exclusion criteria
·        Hypersensitivity to various drugs in the anamnesis;
·        Related decompensated diseases or acute condition, the presence of which can significantly affect the results of the trial;
·        Patients inability to refuse from application of alcohol and/or drugs during treatment;
·        Participation in any other clinical trial;
·        Patients inability to adequately cooperate with the doctor in the research process;
Criteria for patient quit
·        Individual intolerance;
·        The appearance of heavy and/or unexpected adverse events of the patient in the study;
·        Significant deterioration in general condition during the study period;
·        Regime failure of the appointed drug;
·        Refusal of a patient from participation in the study;
 

6. Investigation scheme of the patients.

During Trial for the patients included in the test, was conducted a inspection using clinical, laboratory and instrumental methods for the following parameters, in accordance with the diagnosis of the disease:

6.1. Investigation Methods of patients general status, Criteria for the evaluation of Cancer process flow.

Before and after end of the treatment course:

·        An objective examination (examination:  percussion, palpation, auscultation, general weakness, decreased performance, presence and severity of pain);

·        Subjective assessment of well-being of patients;

·        Histological examination of the tumor;

·        X-ray examination;

·        Complete blood analysis (hemoglobin, erythrocytes, leukocytes, platelets, wbc, color index, ESR);

·        Clinical analysis of Urine (amount, pH, specific weight, leukocytes, erythrocytes, cylinders, epithelial cells, salts, mucus).

Additionally, special methods of investigation were: for lung cancer - bronchoscopy, for cervical cancer - colposcopy, for breast cancer - an additional X-rays (mammography), for melanoma - X-ray examination was carried out.

7. Methods of treatment, data on previous treatment of patients, the main treatment by the investigated drug, concomitant therapy.

Prior treatment of cancer was evaluated with account on characteristics of the methods and forms used drugs and timing periods of their application, as well as the effectiveness of treatment.
 
Drug under investigation
Patients of all experimental groups received the investigational drug "FLARAXIN" by simultaneous injection 1 times a day, in a dose of 2 mg/kg patient's weight, the contents of the vial (150 mg powder FLARAXIN) was dissolved by physiological solution during 16 days - 1 course of treatment, maximum was recommended - III courses of "Flaraxin". The interval between courses was 30 days.
 
Comparative base therapy
Patients of the control group received basic anticancer therapy in accordance with their diagnoses (chemotherapy or radiation therapy for individual indications).
 
The additional treatment. Interaction with other drugs.
During the investigation permitted the appointment of medicines used to treat primary and related diseases, based on the etiology of the disease and condition of the patient, doctor could appointed additionally metabolic, vitamin and other medicines. All drugs used for concomitant therapy, were marked, including name, dose, method of admission, frequency of admission, date of commencement and completion of therapy, in the history of the disease and the individual registration form (Annex 1).

8. Criteria for evaluation of the treatment efficiency and tolerability of the drug.

Evaluation of the treatment efficiency was based on the dynamics of the cancer process, as well as directional changes in the general condition of patients during treatment.

Antitumor effect of Flaraxin was indicated by the disappearance or reduction of the severity of clinical indications of tumor process: reduction of the pain, improvement of general well-being, improved appetite, visual or palpation examination - a reduction or cessation of tumor growth, x-ray evidence of regression or stabilization of cancer process.

Table 1. The examination scheme of patients major groups.
 

Investigated indexes

Examination period

Before treatment

After
I course

Before
II course

After
II course

Before
III course

After
III course

1

2

3

4

5

6

7

Patients conformity evaluation by the criteria for patient inclusion in the trial

 

٭

 

 

 

 

 

Obtaining written informed consent from patient

 

٭

 

 

 

 

 

Anamnesis

٭

 

 

 

 

 

Objective examination

٭

٭

٭

٭

٭

٭

Registration of subjective patient complaints

٭

٭

٭

٭

٭

٭

Histologic examination

٭

 

 

 

 

 

X-ray examination

٭

٭

٭

٭

٭

٭

Complete blood analysis

٭

٭

٭

٭

٭

٭

Clinical analysis of urine

٭

٭

٭

٭

٭

٭

Registration of side effects

 

٭

 

٭

 

٭

Control for compliance with treatment

 

٭

٭

٭

٭

٭

Evaluation of efficiency

 

٭

 

٭

 

٭

Evaluation of tolerability

 

٭

 

٭

 

٭

 
Table 2. Distribution of patients by age.

 

 

Groups

Age, years

21-30

31-40

41-50

51-60

61-70

71-80

Absp.

%

Absp.

%

Absp.

%

Absp.

%

Absp.

%

Absp.

%

Lung Cancer

Experimental group (n=50)

3

6,0

5

10,0

18

36,0

24

48,0

Control group (n=20)

1

5,0

2

10,0

13

65,0

4

20,0

Mammary Gland Cancer

Experimental group (n=40)

2

5,0

10

25,0

12

30,0

16

40,0

Control group (n=20)

1

5,0

8

40,0

7

35,0

4

20,0

Cervical Cancer

Experimental group (n=60)

5

8,3

7

11,7

11

18,3

24

40,0

13

21,7

Control group (n=25)

3

12,0

2

8,0

8

32,0

7

28,0

5

20,0

Melanoma

Experimental group (n=60)

2

3,3

3

5,0

13

21,7

7

11,7

21

35,0

14

23,3

Control group (n=25)

2

8,0

1

4,0

4

16,0

11

44,0

5

20,0

2

8,0

 
Table 3. Distribution of patients by sex.

 

Groups

Sex

Men

Women

Abs. persons

%

Abs. persons

%

Lung Cancer

Experimental group (n=50)

38

76

12

24

Control group (n=20)

11

55

9

45

Melanoma

Experimental group (n=60)

14

23,3

46

76,7

Control group (n=25)

12

48

13

52

8.1. Clinical and laboratory parameters of the Cancer process changes.

Criteria for evaluating the efficiency of the drug Flaraxin in the treatment of lung cancer:

1. Clinical data:

–The disappearance or reduction of the severity of subjective symptoms of antitumor process: improvement of general health, the appearance of appetite, normalization of mental and emotional status.

– The disappearance or reduction of the severity of objective indexes of antitumor process: Cough, sputum production, decrease of pain, and normalization of respiratory function.

2. Laboratory data:

– The positive dynamics of laboratory parameters: X-ray of the lungs - with stabilization or reduction the tumor progression, improvement of laboratory parameters during bronchoscopy.

Criteria for evaluating the efficiency of the drug Flaraxin in the treatment of cervical cancer:

1. Clinical data:

– The disappearance or reduction of the severity of subjective symptoms of antitumor process: improvement of general health, the appearance of appetite, normalization of mental and emotional status.

– The disappearance or reduction of the severity of objective indexes of antitumor process: reduction of excrements from the genital tracts (watery or blood character), reduction of pain syndrome, normalization of physiological functions of urination, defecation.

2. Laboratory data:

– The positive dynamics of laboratory parameters: pelvic radiographs - stabilization or reduction of tumor progression, improvement of laboratory dynamics during colposcopy.

Criteria for evaluating the efficiency of the drug Flaraxin in the treatment of mammary gland cancer:

1. Clinical data:

– The disappearance or reduction of the severity of subjective symptoms of antitumor process: improvement of general health, the appearance of appetite, normalization of mental and emotional status.

– The disappearance or reduction of the severity of objective symptoms of antitumor process: reduction of edema and reduction of breast cancer infiltration, stabilization or reduction of the tumor size by the palpation examination, straightening and change in a positive direction of pathological form of the nipple, decrease of a pain syndrome.

2. Laboratory data:

– The positive dynamics of laboratory parameters: X-rays - with stabilization or reduction of the tumor progression, improvement of laboratory dynamics during mammography.

Criteria for evaluating the efficiency of the drug Flaraxin in the treatment of melanoma:

1. Clinical data:

– The disappearance or reduction of the severity of subjective symptoms of antitumor process: improvement of general health, the appearance of appetite, normalization of mental and emotional status.

– The disappearance or reduction of the severity of objective indexes of antitumor process: reduction of edema and reduction of infiltrative lesion of skin surface, reduction of pain syndrome.

2. Laboratory data:

– The positive dynamics of laboratory parameters: a histological study of tumors - stabilization or decrease in the progression of neoplastic process.

8.2. Criteria for the evaluation of patient general state in dynamics.

Evaluation of the efficiency under experimental drug Flaraxin.

Effectiveness of experimental drug was held by the researcher and the patient on the basis of above mentioned criteria in points on the following scale:

5 points - significant improvement;

4 points - improvement;

3 points - no changes;

2 points - slight deterioration;

1 point - significant deterioration.

Tolerability criteria of the drug Flaraxin.

Tolerability of experimental drug was assessed on the basis of subjective symptoms and sensations reported by the patient, and objective data obtained by the researcher in the treatment process. The dynamics of laboratory parameters, as well as the frequency of occurrence and character of adverse reactions were investigated. Tolerance of drug was estimated by the researcher in points (scores) on the following scale:

4 – Very good

Side reactions are absent, there is no deterioration of the laboratory parameters

3 – Good

Observed minor side effects that does not cause serious problems to the patient and do not require discontinuation of the drug application

2 – Satisfactory

Observed side effects that affect the patient's condition, but do not require discontinuation of the drug application

1 – Unsatisfactory

Side reactions have a negative impact on the patient's condition and its require discontinuation of the drug application

0 – Very unsatisfactory

Side effects are danger to life or health, and require additional medical interventions

Statistical data processing was performed by parametric Fisher-Student method with the calculation criteria of validity.

All Side effects encountered during the testing of the drug and marked by the patient or doctor were registered in the individual registration form and medical history.

9. Evaluation of the treatment efficiency.

During clinical study was find out an increase in life expectancy of patients in experimental group in comparison with control group, and depending on the stage of the tumor, histological type of the tumor, the localization of metastases and the number of treatment courses. Findings are presented in tables.

9.1. General characteristics of patients in groups.

For the realization of clinical trial on drug FLARAXIN were selected two groups of patients within each diagnosis:

·        With the diagnosis of lung cancer, aged from 31 till 70 years with stages III and IV stage of the tumor (experimental group - 50 people, 38 men and 12 women, and a control group - 20 people, 11 men and 9 women) in the experimental group on histological structure: the structure of squamous cell cancer was observed in 23 cases,  in 18 cases -     adenocarcinoma, in 6 cases - small-cell carcinoma, 3 patients experienced carcinoma simplex; in the Control group: in 7 cases with structure of squamous cell carcinoma, 4 - adenocarcinoma, 3 - small-cell carcinoma in 6 patients had carcinoma simplex.

·        With the diagnosis of breast (mammary gland) cancer, women aged from 31 till 70 years on II, III and IV stage of the tumor (experimental group - 40 people and a control group - 20 people)

·        With the diagnosis of cervical cancer, women aged from 31 till 80 years with I, II, III and IV stage of the tumor (experimental group - 60 people and a control group - 25 people) in the experimental group on the histological structure: in 46 cases was squamous cell carcinoma in 11 - adenocarcinoma, 3 patients experienced clear-cell carcinoma, and in the control group on the histological structure: in 16 cases was squamous cell carcinoma, 4 - adenocarcinoma, in 5 patients had clear-cell carcinoma.

·        With the diagnosis of melanoma, aged from 20 till 70 years with I, II, III and IV stage of the tumor (experimental group - 60 people, 46 women and 14 men, and a control group - 25 people, 13 women and 12 men).

Patients of all experimental groups received experimental drug "FLARAXIN", produced by Scientific and Treatment Center for Cancer Curing "PHOENIX" Ltd (Kharkov, Ukraine), as follows: the drug was injected intravenously in doses of 1-2 mg/kg 1 time a day, during 16 days on a daily basis - I course of Flaraxin treatment, the interval between courses was 30 days, only maximum III courses was recommended during patients treatment, patients of the control group received the recommended standard therapy.

9.2. Evaluation of the direction flow for the Cancer process.

During the trial for all patients included in the study were conducted examination using clinical, laboratory and instrumental methods with the following parameters: physical examination (inspection, survey), the subjective evaluation of well-being of patients, radiological and histological examination of the tumor, the clinical blood analysis, clinical analysis of urine before start of the treatment and after end of the treatment course. Also in the examination were included special methods depending on the nosology of the tumor: lung cancer - bronchoscopy, cervical cancer - colposcopy, melanoma - X-ray examination was not carried out.

9.3. Dynamics of the patient’s general condition indexes in experimental and control groups.

Clinical observation and laboratory studies were conducted in dynamics - before treatment, after the end and at the beginning of the next course of treatment, at 17, 47, 65, 95, 113 days since the start of the study.

During the study we found out a statistically significant increase in life expectancy of patients in the experimental group compared with the control group, depending on the stage of tumor, the distribution was as follows / Table 4/:

Table 4. Comparison of resultant estimation of life expectancy in patients receiving the drug "FLARAXIN" (experimental group) and receiving standard therapy (control group), depending on the stage of the tumor.

Stage of cancer process

I stage

II stage

III stage

IV stage

Life duration, мonths

Exp

group

Control group

Exp

group

Control group

Exp

group

Control group

Exp

group

Control group

Lung cancer

-

-

-

-

9,7±0,5

٭

5,1±0,3

6,4±0,8

3,6±0,4

Breast cancer

-

-

11,8±0,5

٭

6,3±0,4

9,3±0,9

٭

6,5±0,3

7,2±0,8

4,6±0,6

Cervical cancer

12,8±0,8

٭

3,1±0,6

10,9±0,6

٭

4,4±0,3

8,7±1,2

3,4±0,7

5,8±0,3

3,1±0,2

Melanoma

12,5±0,9

٭

4,1±0,6

11,8±0,6

٭

5,6±0,4

9,2±0,8

3,5±0,5

6,1±0,4

3,1±0,3

٭р <0,05 in relation to the experimental group

The data in table № 4 shows (p <0,05) significant increase in life expectancy in groups of patients treated with the experimental drug FLARAXIN, especially in the early stages of the disease and compared with control groups of patients.

Similar positive trends in increasing of life expectancy were found in the experimental groups: lung cancer and cervical cancer according to histological tumor type and compared with control groups of patients (Table 5).

Table 5. Dependence of life expectancy in patients receiving the drug "FLARAXIN" (experimental group) and receiving standard therapy (control group), depending on the histologic type of tumor.

Lung Cancer

Small-cell
cancer

* Undifferentiated cancer

* Squamous-cell cancer

* Glandular cancer

Exp

group

Control group

Exp

group

Control group

Exp

group

Control group

Exp

group

Control group

Life duration, month

5,3±0,1

1,1±0,1

6,2±0,3

3,1±0,3

7,8±0,3

4,0±0,2

9,2±0,4

3,8±0,3

 

Cervical cancer

Squamous-cell cancer

٭ Adenocarcinoma

٭ Clear-cell carcinoma

Exp

group

Control group

Exp

group

Control group

Exp

group

Control group

Life duration, month

5,4±0,3

3,1±0,3

7,6±0,6

4,6±0,4

8,2±1,1

3,6±0,4

٭р <0,05 in relation to the source data

The obtained data in Table 5 give a statistically significant rising of life duration (p <0,05) for patients who received the experimental drug FLARAXIN with glandular, squamous-cell, undifferentiated, small cell lung cancer and patients with clear-cell carcinoma, adenocarcinoma and squamous-cell Cervical Cancer in comparison with Control groups of patients.

Also during the study were marked dependence of life duration and the results of treatment with metastases in experimental groups of patients with melanoma, lung cancer and breast (mammary gland) cancer (Table 6.1, 6.2, 6.3).

Table 6.1. Dependence of life expectancy in patients receiving the drug "FLARAXIN" (experimental group) and receiving standard therapy (control group), depending on the localization of metastatic spreading process (Melanoma).

Localization of metastases

Quantity of patients

Subjective effect

Without effect

Stabilization of the process

Partial regression

Complete regression

Life duration, month

1

Skin and soft tissue

11

10 (91%)

1 (9,1%)

3 (27,3%)

6 (54,6%)

2 (18,2%)

٭9,1±0,8

2

Trema

4

3 (75%)

1 (25%)

-

3 (75%)

1 (25%)

٭8,6±0,6

3

Lymph nodes

13

9 (69%)

4 (31%)

3 (31%)

9 (69%)

1 (7,7%)

٭7,2±0,4

4

Visceral organs

6

6 (100%)

2,5±0,3

5

Bones

4

4 (100%)

2,8±0,2

6

Brain

3

2 (67%)

1 (33%)

2 (66,6%)

1 (33%)

5,8±0,2

7

Multiple organs

19

13 (68,4%)

6 (31,6%)

5 (26,3%)

10 (52,6%)

1(5,3%)

4,1±0,4

٭р <0,05 in relation to the source data

Statistically significant results (p <0,05) presented in Table 6.1 indicates that the application of the experimentaldrug FLARAXIN for patients diagnosed with melanoma, had a positive impact on significantly increasing life duration and improves general health (reduces pain, general weakness, dizziness, increasing work abilities) in patients with metastases in the skin and soft tissue, lymph nodes, vulva, and multiple organ metastasis in comparinson with metastasis to visceral organs, bones, as a result of drug treatment FLARAXIN has most positive influence for patients with metastases in skin and soft tissue, on the second place - metastases in lymph nodes, on third place were patients with multiple metastases, on a fourth place  - metastases in vulva and has no influence on a patients with metastases in bones and metastases in the visceral organs.

Table 6.2. Dependence of life expectancy in patients receiving the drug "FLARAXIN" (experimental group) and receiving standard therapy (control group), depending on the localization of metastatic spreading process (Lung cancer).

Localization of metastases

Quantity of patients

Subjective effect

Without effect

Stabilization of the process

Partial regression

Complete regression

Life duration, month

1

Pleura

10

2 (20%)

8(80%)

2 (20%)

6(60%)

٭7,7±0,6

2

Lymph nodes

17

13 (76,4%)

4(23,6%)

8 (58,8%)

4(23,5%)

2(11,8%)

٭7,4±0,5

3

Lungs

6

5 (83,3%)

1(16,7%)

3 (50%)

2(33,4%)

1(16,7%)

8,2±0,3

4

Bones

4

4(100%)

2,3±0,3

5

Liver

5

5(100%)

5 (100%)

2,1±0,2

6

Multiple organs

5

5(100%)

3 (60%)

5,0±0,1

7

Brain

3

2(66,6%)

1(33,4%)

1(33,4%)

1(33,4%)

1(33,4%)

5,7±0,1

٭р <0,05 in relation to the source data

The results presented in Table 6.2 show that the application of experimental drug FLARAXIN for patients diagnosed with lung cancer, has a positive impact on increasing life duration and improves general health (reduces pain, general weakness, dizziness, increased working efficiency), in patients with metastases in pleura, lymph nodes, lungs, multiple organs and brain in comparison to patients with metastases in bones and liver (p <0,05). Positive results of the treatment with FLARAXIN were for patients with metastases: On the first place - in lymph nodes, on second place - pleura, on a third - in lungs and on fourth - metastases in brain and on fifth - in multiple organs, much worse were results for patients with metastases in the liver and in bones.

Table 6.3. Dependence of life expectancy in patients receiving the drug "FLARAXIN" (experimental group) and receiving standard therapy (control group), depending on the localization of metastatic spreading process ((Mammary gland) Breast cancer).

Localization of metastases

Quantity of patients

Subjective effect

Without effect

Stabilization of the process

Partial regression

Complete regression

Life duration, month

1

Lymph nodes

8

7(87,5%)

1(12,5%)

 

4(50%)

4(50%)

٭13±1,2

2

Lungs

4

2(50%)

2(50%)

1(25%)

2(50%)

1(25%)

٭10,2±0,8

3

Bones

2

2(100%)

 

2(100%)

 

 

7,2±0,5

4

Pleura

2

2(100%)

-

 

2(100%)

 

8,1±0,4

5

Liver

2

-

2(100%)

-

-

-

5,6±0,5

5

Skin

2

2(100%)

-

2(100%)

-

-

4,6±0,3

6

Multiple organs

17

13(76,4%)

4(23,6%)

8(47%)

6(35,3%)

 

6,2±0,4

٭р <0,05 in relation to the source data

The obtained data in Table 6.3 indicate that the application of experimental drug FLARAXIN for patients diagnosed with breast cancer (p <0.05) significantly have positive impact on increasing of life duration and improve general health (reduces pain, general weakness, dizziness, increases working efficiency), for patients with metastases in lymph nodes and in lungs, in multiple organs, in pleura, skin metastases in comparison to metastasis: in the liver and bones. Positive results of the treatment with FLARAXIN were for patients with metastases: On the first place - lymph nodes, on second place - lungs, on a third - multiple organs and on fourth - metastases in pleura, then with skin metastases. Much worse situation were for patients with metastases in bones and liver.

It was also revealed a positive trend in life duration depending on the number of Flaraxin courses applied in the experimental groups of patients (Table 7).

Table 7. The total evaluation of life duration for patients receiving the drug "FLARAXIN" (experimental group) dependent on the number of Flaraxin treatment courses.

Quantity of treatment courses

Quantity of patients

Average
Life duration, months

Melanoma

I treatment course

23 (38,3%)

٭ 3,9 ± 0,5

II treatment courses

10 (16,7%)

٭ 6,2 ± 0,7

III treatment courses

27 (45%)

٭ 10,4 ± 1,1

Lung cancer

I treatment course

29 (58%)

٭ 2,4 ± 0,3

II treatment courses

15 (30%)

٭ 6,6 ± 0,6

III treatment courses

6 (12%)

٭ 8,9 ± 0,8

Cervical cancer

I treatment course

26 (43,3%)

٭ 2,6± 0,2

II treatment courses

11 (18,3%)

٭ 3,6± 0,3

III treatment courses

23 (38,4%)

٭ 7,7± 0,6

(Mammary gland) Breast cancer

I treatment course

11 (27,5%)

٭ 5,2 ± 0,4

II treatment courses

12 (30%)

٭ 9,4 ± 0,9

III treatment courses

17 (42,5%)

٭ 17,4 ± 1,4

٭р <0,05 in relation to the source data

Thus, life duration in the experimental groups of patients in all nosological forms of cancer have significant improvement (p <0,05) and were directly proportional to the number of Flaraxin treatment courses.

During clinical trial for all patients included in the research were carried out the clinical blood analysis (hemoglobin, erythrocytes, leukocytes, platelets, leukocyte counts, color index, ESR) and clinical analysis of urine (amount, pH, specific gravity, leukocytes, erythrocytes, cylinders, epithelial cells, salts, mucus) before treatment and after completion of the course. During this process no abnormalities in blood and urine in the experimental groups before, during and after treatment were identified, all indicators of laboratory analysis also were in norm.

10. Evaluation of the experimental drug Flaraxin on tolerability, on allergic and local irritating action, on general and side (toxic) reactions.

Only two cases with side effects were registered during all process of clinical trial were reported on patients with cervical cancer diagnosis and on 1 patient with melanoma. Side reactions were observed in the form of nausea and vomiting after injection of experimental drug “FLARAXIN” and this reaction was possible related with previously carried out chemotherapeutic treatment. Later, after 3-4 days of “FLARAXIN” treatment, all allergic reactions disappeared in these patients. Such cases were exceptional and were not considered as side effects due to low intensity, but, nevertheless, have been identified as satisfactory tolerability of experimental drug.

In a group of patients with breast cancer was one patient had allergic reaction in the form of urticaria, which was cupped by standard anti-allergic therapy, and was evaluated as individual intolerance to the iodine containing drugs.

Based on subjective data and objective results of clinical and laboratory studies of patients in the treatment cancer process by experimental drug "FLARAXIN" were found that the tolerability of the experimental drug was "Good", except cases with individual intolerance to drug.

The laboratory data on patients conditions during treatment are testifying that no significant difference were observed in the investigated indices before and after treatment, which indicates that drug “FLARAXIN” does not have general toxicity and sensitizing effect on the patients.

11. Discussion of the results and main conclusions.

Clinical trial of therapeutic effectiveness and endurability of the drug “FLARAXIN” showed:

 

1.      Drug “FLARAXIN” produced by “Scientific and Treatment Center for Cancer Curing PHOENIX” (Kharkov, Ukraine) has a high anti-tumoral activity and good endurability, which gives the ground to recommend FLARAXIN for wide clinical application in practice of oncologic diseases treatment, especially on primary stages of tumoral process and in combination with traditional methods of treatment as a carcinostatic drug.

 

2.      Drug “FLARAXIN” also should be recommended between the courses of the traditional treatment (chemotherapy and radio-therapy) and after the end of the treatment, as a remedy of adjuvant and non-adjuvant therapy, because it can prevent relapse of the cancer and metastasis (Mts) spreading of oncologic process in the body of patient.

 

3.      In the case of obtaining objective effect (tumor regression or stabilization) the treatment should have prolongation until the positive effect will remain.

 

4.      Drug “FLARAXIN” has a good endurability and does not have allergic reactions, besides the cases of individual intolerance to iodine containing drugs.
 
 

 

Executors:

Chief of the III Oncological Department (mammary gland cancer) of CSMU
d.m.s, professor – A.G.Filenko
Chief of the Radiological Department (cervical cancer) of CSMU
d.m.s., professor – N.I.Verizhnikova
Chief of the II Oncological Department (melanoblastoma) of CSMU
d.m.s., professor – I.V.Pohvalin
Rector:
of the Crimea State Medical University (CSMU) named after S. I. Georgievsky
MD, professor - A.A.Babanin
Leader:
Chairman of the Oncology Department of the Crimea State Medical University (CSMU)
named after S. I. Georgievsky
MD, professor – V.M.Efetov
Responsible Executor:
Assistant of the Oncology Department (lungs cancer) of CSMU
named after S.I.Georgievsky
d.m.s, professor – A.V.ProtsenkoExecutors:
 
 


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