Transcript The “Normogen” is new direction to creating specific

«Normogen» –
antitumor preparation
of the future
Slide presentation
Real Med Company Ltd, Almaty, Kazakhstan
All rights reserved
Conception:
Preparation “Normogen” – a new direction for
creation of selective antitumor drugs.
Main steps:
1. Creation of the oncogenesis theory
(1994-2006)
2. Production of the “Normogen” preparation in the
medicinal form for intravenous injection
(2003-2006)
Oncogenesis theory
Females “pump in” special proteins–immunoglobulins –
into fetus serum through placenta. There are antiidiotypical
antibodies to alfa-fetoprotein (AtAFP)
among the maternal immunoglobulins.
Presence of the maternal AtAFP in the
fetus blood defends it from cancer.
Low concentration or narrow spectrum
of AtAFP leads to development of the
tumor diseases.
“Normogen” preparation contains essential spectrum of
antiidiotypical antibodies to alfa-fetoprotein.
Introduction of such antibodies into organism provides
prophylactics and treatment of tumor diseases.
Validation of the oncogenesis theory
scientific conception
1. Certificate of the member
of the II world-wide congress on
immunopathology and respiratory
allergy
(Russia, Moscow, May 14-17, 2004).
2. Certificate of the winner of
the II world-wide congress on
immunopathology and respiratory
allergy
(Russia, Moscow, May 14-17, 2004).
Proofs of novelty of the technical
problems solution
1. Patent of the
Republic of Kazakhstan
2. Eurasian patent.
3. Registered trademark
Mechanism of action of the “Normogen” preparation
Mechanism of action of the “Normogen” preparation
All cells have special structures - AFP receptors
(ReAFP), which are located on their surfaces (they
are marked by red color in the figures).Cells usually
have a low density of ReAFP as it showed in the
first figure.
The ReAFP density on the surfaces of the dividing
cells is very high (second figure). At low density of
ReAFP the “Normogen” preparation blocks ReAFP
and prohibit obtaining of the unsaturated fatty acids
by cell that results in stoppage of cell division.
At high density of ReAFP the “Normogen” preparation
stimulates destruction of the transformed cells by
perforation of their cell walls with activation of the
complement (serum protein), causing their death due
to complement-mediated lysis as it is shown on the
last figure.
Preclinical trials of the
“Normogen” preparation
Use of the “Normogen” preparation for
prevention of cancer :
1. Control set: Lungs of rats with the
tumors induced by intravenous
introduction of cancer cells
2. Action of the “Normogen”
preparation (about 60% of the rats
lungs are free from tumors);
3. Action of the “Normogen” preparation
in combination with exogenous
complement (serum protein) - about 90%
of the rats lungs are free from induced
tumors.
Preclinical trials of the “Normogen”
preparation action on the spontaneous tumors
Action of the “Normogen” preparation on
the spontaneous tumors:
1. A dog with a name “Verna”, of 12 years old;
2. Two kinds of tumors are identified in the dog:
a) Adenocarcinoma of the mammary gland (98 cm3);
b) Tumor in the vagina wall (Ǿ = 4 cm)
3. The tumor in the vagina wall disappeared on the
third day of the treatment. The volume of the
mammary gland on the 15-th day reduced to 45 cm3
(in two times)
Report of the Institute of Oncology on the
preclinical trials of the “Normogen” preparation.
The “Normogen” preparation is absolutely nontoxic
even if it is used in high dosages
 “Normogen” provides a high antitumor action (80,0%,
in some cases – 100%)
 The antitumor “Normogen” preparation shows high
antimetastasis activity that reaches 90,5%, and in some
cases – 100%
 The “Normogen” preparation is effective against cancer
cells regardless of type or localization of tumor
 Preliminary introduction of the “Normogen” preparation
reduces the possibility of the induced tumors appearance
more than by 90.0%
 The best way of the “Normogen” preparation introduction
is the intravenous introduction
 The “Normogen” preparation shows its maximal antitumor
activity at presence of excess quantity of the complement

Clinical trial of the “Normogen” preparation (1st phase).
The tested group was comprised of 15 patients with 12 diagnosis of cancer in
the advanced form:

Pleura mesothelioma – 1;

Primary, multiple cancer (sigmoid intestine, thyroid gland, breast cancer) – 1;

Cancer of the cardioexophageal part of stomach, cancer of esophagus,
stomach cancer – 2;

Cancer of lung – 1;

Breast cancer – 3;

Salivary gland cancer – 1;

Cancer of kidney – 1;

Rectal cancer – 1;

Urinary bladder carcinoma – 1;

Testicle cancer – 1;

Ovarian carcinoma – 1;

Spinal chondrosarcoma –1.
The patient did not undergo immune-histological selection or any other typing.
Participation of the patients with such different diagnoses in the clinical investigations
was provided with two purposes:

Checking the safety of the preparation and determination of the dosage relationship

Preliminary assessment of the “Normogen” preparation spectrum of action against
differently localized tumors and determination of the effective therapeutic dosages
Changes in the patients’ quality of life after
application of the “Normogen” preparation.
66.7% of the patients after treatment with the “Normogen” preparation Felt
themselves noticeably better. Their aches considerably reduced or completely
disappeared, their appetites got better. 20% of the patients did not notice any
improvements in their states. 13.3% of the patients complained of their state
worsening. The dynamics of changes in the patients’ quality of life is showed
in the table. Parameters of the patients’ quality of life that are marked by the
1st degree of the World Health Organization rose from 53.3% to 66.7% (in
1.2 times), and the states of the patients with the 2nd and 3rd degrees changed
in the same way (in 1.9 and 1.2 accordingly).
Observations
stages
Number of
patients
WHO
(in degrees)
0
1
2
3
4
By Karnovski
(in %)
100
80 - 90
70
60 - 40
-
Before the
treatment
15
8
53,3%
2
13,3%
5
33,4%
-
After of the
treatment
15
10
66,7%
1
6,7%
4
26,6%
-
Clinical presentations of the “Normogen” preparation action.
On the 3-4 day from the beginning of treatment with the “Normogen” preparation
most of the patients had:
 Significant reduction or complete disappearance of aches, improvement in
appetites, improvement in state of health and mood;
 Temperature normalization;
 Reduction and complete resolution of lymphostases, which have place, for
example, at the breast cancer;
 Blood parameters normalization;
 Rehabilitation of the natural activity of the patient’s excretory systems;
 Improvement in the motion activity.
Reductions in the dimensions of the tumors and lymphatic nodes were registered
by instrumental methods (roentgen, ultrasonic scanning etc).
On the background of the improvement in quality of life the progress of the tumor
disease were registered at 26.66% of the patients. Total antitumor activity of the
“Normogen” preparation in the mode of monotherapy reaches 73.34%.
None of the immunobiological preparations that are used in the oncology
practice has such an antitumor activity and broad spectrum of action.
A commercial advantage of the
“Normogen” program
The program of production and application
of the “Normogen” preparation is attractive
to investors and socially significant for the
State. Availability of the raw material and
Relatively simple technology provide the
Economic efficiency over 1000% (relatively
to world prices on the existing antitumor
preparations).