The National Polytechnic Institute (IPN) contributes to the treatment of various autoimmune disorders, infectious diseases, chronic-degenerative and respiratory by the Transferón, which today is seeking to be employed as an auxiliary in the treatment of patients with Covid-19.
We are waiting for the authorizations required on the part of the authorities, both of the ethics committees and subsequently the health authority to initiate a study of Phase 2-3, which allows us to evaluate and do a scan therapeutic of our product in patients with covid positive,” said dr. Sonia Mayra Pérez-Tapia, Executive director of the Unit of Research, Development and Innovation in the Medical and Biotechnology (Udimeb) of the National school of Biological Sciences (ENCB).
What is searching with the supply of the treatment?
The intention is that the administration of Transferón in the early stages, from the first respiratory symptoms when they are mild may help to prevent complications of the disease.”
Transferón it is an immunomodulator, is a mixture of peptides which has demonstrated its effectiveness as a regulator of the immune system in other diseases, including respiratory illnesses… from the inference of the product, we dared to infer that the product could have an application to prevent the complications.”
The product has the active ingredient of the dialyzable extract of leukocytes (blood cells), which is obtained from leukocytes of healthy people and is a product one hundred percent polytechnic, whose main activity is to modulate the immune response of the body, they can increase it or reduce it, according to the condition in which it is applied.
In this regard, dr. Perez Tapia he stressed that over 40 years of work of basic research, clinical, and pharmaceutical development are supported in the regulations national and international levels to ensure the quality, safety and efficacy of the drug, which is only useful for conditions that involve alterations of the immune response.
Until the time we only recommend its use in conditions where it is needed in a modulation of the immune response, we do not have evidence that it works as a prophylactic, i.e. to prevent, and thus is not useful for healthy people”, he clarified.
The Transferón is a dialyzable extract of leukocytes composed by over 400 different peptide molecules, however, its complexity, the IPN has been characterized and sequenced at one hundred percent.
We have a production process single, standardized and controlled, which has allowed us to possess the patent until 2032 at national and international level, specifically already granted in the united States, Canada, Colombia, Peru, and the European Community, and pending in Brazil, Chile and Guatemala. It is unique and unrepeatable, since the IPN is the only educational institution of the country with sanitary license for the manufacture of blood product,” said the expert in immunology.
For patient safety pharmacovigilance rules have been strengthened over time and the Transferón account with a program of pharmacovigilance and active according to the national policy in force, in addition there is an area of quality control that ensures the reproducibility and control of each phase of the process for obtaining the extracts,” he explained.
He also detailed the process of obtaining, purifying, and control is costly, because it involves the use of special filters (which are disposable), and several stages of clarification, in addition to all of the controls that should be met when manufacturing biological and stability testing, raw material analysis and finished product, as well as the maintenance of the quality management system with which you must comply with our organization.
In addition allocated significant resources to continue the scientific research that enables us to understand the mechanisms of action of the complex mixture peptide of our extracts.
Dr. Perez Tapia said that even when you do not know the mechanism of action, nor had the process of obtaining robust and reproducible Transferón, dince the project began in 1978 it was observed favorable response in patients with herpes and atopic dermatitis.
With the passage of time it developed various research projects to support the treatment of other conditions such as respiratory, hypersensitivities, and immunodeficiencies.
The cancer, he said, is one of the conditions in which you can appreciate the activity of the productbecause , when a person receives chemotherapy to destroy the malignant cells of rapid replication, but also other that are played at high speed, such as the bone marrow and involved in the growth of the hair.
The generated neutropenia (low neutrophils) is normal for the patient to feel weakened, the Transferón has demonstrated its utility in reducing neutropenia by chemotherapy by activating the immune system to the cells to reproduce quickly, even when not directly have antitumor activity,” he said.
He also noted that a team transdisciplinary integrated by 45 scientists working in the Unit of Research and Development in Bioprocesses (Udibi) –part of the Udimeb of the IPN, has contributed to the characterization of each one of the components of the medication, side of experts from the National Autonomous University of Mexico, of the University of Davis in California, united States of America, as well as the advice of an american company.
In addition, a group of more than 24 medical specialists and experts in clinical research in the Unit of External services and Clinical Research (USEIC) –also of the Udimeb– giving medical care with a specialty in immunology, designed and executed clinical studies that support the use of the product,” said the specialist in immunology.
The USEIC account with one of the more robust programs for pharmacovigilance in the country, as all of the patients who come to consultation is incorporated into the protocol of that program.
In this regard, the Polytechnic has generated a very large amount of information about safety, mechanisms of action, processes disclosed in scientific papers that give support to the medicine that has allowed us to open gap at the global level on our product, one hundred per cent of polytechnic and one hundred percent mexican,” she said.
In terms of the raw material, the scientist pointed out that the leukocytes are made through agreements established with blood banks certificates, because all blood products are at risk of transmission of viruses, but also apply strict rules to ensure the safety of the product, such as the use of the filters already mentioned.
Finally dr. Mayra Perez emphasized that the National Polytechnic Institute has the patent on the Transferón, which is the only immunomodulatory drug that complies with the standards of quality, safety and efficacy.
Other products that are marketed as supplements or food supplements and claim to transfer factor does not comply with the NOM 059 and might put at risk the health of the people, in addition to the only product that produces the IPN is Transferón”.
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