Thus, the results of 1st phase of the clinical trials of domestically produced immunobiological, antitumoral "Normogen" drug showed a series of interesting properties of the drug that had been developed by Kazakhstan researchers.

It is necessary to note that abovementioned properties of the drug were predetermined by absolutely knew approach both at theoretical substantiation of the mechanism of "Normogen" preparation action and at practical creation of drug manufacturing technology and development it to the drug formulation. The great advantage of the "Normogen" preparation is its high safety, absoluty absence of toxicity. All revealed adverse reactions are connected with reaction of the recipient organism to introduction of an alien protein.

The same reactions are observed at use of most protein immunomodulatory preparations and drugs on the base of specific antibodies.

The most unusual property of the new preparation is, most of all, polypotency, that is, its capability to affect on different oncological diseases, which have different localizations. Besides, the preparation turned to be very effective at multiple combined forms of primary cancer. No one of the know immunomodulatory or target preparations, which are used in practical oncology, has the same property of polypotency.

Antitumor activity of the "Normogen" preparation was studied at patients with different kinds of cancer, and, moreover, the positive effect of treatment was registered at patients, who had not been specially selected or had not been immunohistochemically typed for presence of the oncomarkers or other target protein-antigens on cell membrane surfaces of the tumor cells.

It is registered, that the use of the "Normogen" preparation improves hematological parameters, reduce the number of leucocytes-supressors, improve ratio CD4/CD8, in favor of leucocytes helpers with improvement immunological status of the organism.

It is necessary to note that the "Normogen" preparation shows the cytolysing activity in the presence of functionally active complement. This predetermines the necessity of periodical inspection of complement quantity and functional activity in the serum of the patients during the treatment and, if it is necessary, correction of complement parameters by introduction of fresh frozen plasma.

1. The "Normogen" drug is a safe medical preparation. The spectrum of the adverse reactions (fever, temperature rise, tachycardia) is the same as those observed at application of known immunomodulatory preparations and monoclonal antibodies. The intensity of the adverse reactions does not depend on the one-time dose and is the same both at 100 mg dose and at 1000 mg dose;

2. Of the two regimens of the "Normogen" preparation application (daily and 3 times a week), the preferable one is the regimen of daily introduction of the drug with total course dose exceeding 5000 mg;

3. The subjective effect of therapy with the "Normogen" preparation is registered at 66.7% and expressed in better feelings, improvement of appetite, and significant reduction of full disappearance of the aches. The parameters of the vital quality that had 1st degree raised in 1.2 times and, as a result, the number of the patients that had the vital quality of 2 or 3 (in 1.9 and 1.2 times respectively) reduced.

4. The study of the objective effect at monotherapy with the "Normogen" preparation showed that 1 patient (6.67%) had a partial effect (reduction of metastasis and lymphatic nodes more than by 50%) was registered in one case (6.67%) of testicle cancer that was expressed in the reduction of the lymph nodes in a retroperitoneal space. Four patients (26.67%) had a stabilization of the process with positive dynamics (with degree of 30-40%) expressed in reduction of the lymphostasis in limbs, reduction of peritoneal lymphatic nodes, registered at roentgenological and CT investigations. 6 patients (40%) were registered to have stabilization of the oncology process without dynamical shifts. 4 patients (26.66%) were registered to have progress of the disease during the treatment.

5. The therapy with the "Normogen" preparation has positive influence on the hemoglobin content, number of erythrocytes, leucocytes, segmented neutrofils, trombocytes, and also on parameters of humoral and cell immunity. On the basis of the above listed positive results of the performed investigation, in the scale of the 1st phase of clinical investigations, RGKP Kazakh Oncology and Radiology Research Institute recommends:
- to carry out the 2nd phase of the clinical trials of the "Normogen" preparation.