Crises generate opportunities. Is there any doubt that the COVID-19 pandemic was the greatest health crisis that Cuba and the world experienced in the last century? Amid the pain for the lives lost and the economic consequences that are still felt today, during those months the inventiveness and capacity of Cuban science and medicine were used to the maximum to provide the best possible care to those who suffered the virus.
In those months, a series of medicines and pharmaceutical products that saved thousands of lives entered the national market. This section dedicated an article to one of them, Jusvinza, which, although it had been created for the treatment of rheumatoid arthritis, proved to be effective in patients with severe forms of COVID-19.
Another of the drugs that began to be used in hospitals, especially in the country’s intensive care units, is Biomodulin T (BMT). It is, according to a document issued by the Cuban regulatory agency, CECMED, a medicine with “immunomodulatory activity,” that is, it helps regulate the body’s defenses and is prescribed in patients “with mainly immunological dysfunction (alteration) of a cellular type, such as repeated infections in adults and older adults.”
The thymus, a great unknown
Before continuing to talk about Biomodulin T, we must stop talking about a practically unknown organ, even within the medical community, and closely linked to BMT: the thymus. It is the last of the large glands to be studied by medical science.
Its name is due to its resemblance to the thyme flower (Thymus vulgaris). According to an article that appeared in a Cuban medical journal, the first references to this organ are due to Galen, who in the second century thought that its function was “the purification of the nervous system.”
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Since then and for seventeen centuries, various and, in some cases, puzzling functions have been attributed to it. It was not until 1961 that the Australian immunologist Jaques Miller discovered its vital role within the immune (defense) system.
It is an organ made up of different compartments where we find small, very well-packaged lymphocytes (defensive cells), called thymocytes, surrounded by “caretaker” or “nurse” cells. The latter have an essential function in the maturation of thymocytes, that is, they help them acquire the necessary characteristics to perform their functions.
T lymphocytes (the “T” is because they mature in the thymus) are a cell group that we have all heard about and that have varied and essential functions within the immune system. To give you an idea of its importance, HIV, without the timely medication currently available, destroys a group of these lymphocytes, which has terrible consequences for patients.
In addition to the maturation of T cells, the thymus produces a group of hormonal substances called thymic factors. These have the function of regulating the response of the immune system, stimulating or slowing it down, as needed.
A peculiarity of this organ is that after puberty a process of involution begins in it that ends in the sixth decade of life. During this process, the gland decreases in size, weight, and activity. This will have dramatic consequences for the body’s ability to defend itself against different antigens, such as viruses and bacteria. The aforementioned is part of a process known as immunosenescence and explains why with age we are more likely to suffer from diseases.
What is immunosenescence?
The immune system, like any other system, is affected by aging. The set of physiological changes that occur with age is what is called immunosenescence, according to a specialized article.
This is blamed for the increase in the appearance of infectious and autoimmune diseases, different types of cancer and the lower effectiveness of vaccines. In addition, it is considered to be the genesis of chronic non-communicable diseases such as hypertension, diabetes, and neurodegenerative pathologies such as Parkinson’s and Alzheimer’s.
But what does this have to do with Biomodulin T? Well, it is a fact that the involution of the thymus plays a fundamental role in immunosenescence and, logically, in the appearance of the diseases we referred to before.
Essentially, this occurs because T lymphocytes decrease in quantity and, in addition, the proportions between their different populations vary (there is more than one type of T lymphocytes in the body).
The above, although it is considered an adaptive change of the organism, leaves us exposed to a series of antigens, especially those that we have not faced before, and also to cancer cells, the internal enemy, and reduces the effectiveness of the vaccines.
The path of Biomodulin T: 1984 to 1993
This was known by a group of Cuban researchers from the Biomodular Laboratory, belonging at that time to Cubanacán S.A., led by Dr. Román R. Rodríguez Martín, who in 1984 began to search for a drug that would reverse, at least in part, immunosenescence. That is the starting point on the path of BMT, which, according to an article that appeared in a Cuban medical journal, is “a diafiltered extract of calf thymus.” What does it mean?
Diafiltration is a process that seeks the separation and purification of a substance concerning others contained in a solution. This is a combination of dilution (water is added) under very controlled conditions, of course, and filtration through membranes. This is done in several cycles until a compound with the required purity conditions is obtained.
According to an article that appeared on the Europe PMC website, this first stage of conception and obtaining the product, as well as the development of a reproducible method for its production, took close to ten years, from 1984 to 1993. During that time, in addition, the researchers created a pilot production plant, which allowed them to produce enough BMT to begin researching this substance, which in essence is a set of thymus proteins.
Second stage 1993 to 1994
According to the aforementioned article, 1993 and 1994 were fundamental for the development of the BMT. In this period, studies were carried out that demonstrated the ability of BMT to modulate the activity of the immune system, that is, stimulate or depress it according to the body’s needs.
At this stage, its anti-inflammatory and antitumor effect was demonstrated. It is important to remember that inflammation and anti-inflammation are two sides of the same coin, they are complementary processes that are happening all the time in our body and both play a vital role in keeping us healthy.
The same could be said of the antitumor effect. Malignant cells are constantly emerging in the body; whether neoplasms develop depends largely on the ability of the immune system to prevent it. The BMT proved to be effective in that regard as well.
In 1994, a series of preclinical studies were also carried out in different species such as rats, rabbits, pigs, and dogs, which demonstrated that BMT was safe in humans. This led to the first license being granted that year by the Cuban regulatory agency to the Biopreparations Laboratory, which was located at the Luis Díaz Soto Military Hospital. This allowed clinical studies to begin.
In 2008, the titleholder of the product passed to the Center for Biopreparations (BioCen), and in 2009 the CECMED granted the Institute of Hematology and Immunology authorization for its use in children with Thymic Hypoplasia, according to a work published in the Revista Habanera de Ciencias Médicas.
Third stage: 1994 to 2019
According to the article by Dr. Rodríguez Martín, even before the preclinical studies concluded in 1994, the team of researchers had already begun to test the effectiveness of the drug in a series of patients suffering from different diseases. These investigations had encouraging results.
The list is really long, but among the pathologies in which this product was tested were: malnutrition in children under 1 year of age; multiple sclerosis, chronic obstructive pulmonary disease (COPD); bronchial asthma. Its preventive effect on respiratory infections in the elderly was also demonstrated. A particularity of this stage is that many of the diseases we referred to were treated with a homeopathic formulation of BMT.
Homeopathy, according to an article on the subject, is a therapeutic system that is based on Hippocrates’ idea that what is similar cures what is similar, hence its name. Homeopathic substances have different origins (animal, mineral, vegetable…) and are characterized by producing in healthy subjects symptoms very similar to the disease they seek to treat.
Another distinctive feature of this method is that the doses are small, since the active ingredient, that is, the fundamental ingredient of the medicine and responsible for the desired effect, is diluted to the point of almost disappearing. Precisely in this detail is one of the greatest “weaknesses” of the method, since for many doctors it is difficult to accept that it is possible to cure, essentially, with water. Thus, at best, homeopathic treatments are exceptional. Perhaps this is why BMT did not have greater relevance and was practically unknown until the beginning of the pandemic.
Fourth stage: 2019 to present
At least since 2019, studies have been published that express the union of the Department of Clinical Immunology, the Center for Molecular Engineering (CIM), the National Center for Biopreparations (BIOCEN) on the Cuban side and the University of Lausanne, Switzerland, to understand the effects BMT immunomodulators on immunosenescence in older adults, with encouraging results. Unlike other research we referred to above, instead of using homeopathic presentations, at this stage an injectable preparation containing 3 mg of BMT has been tested.
These investigations were undoubtedly vital in boosting the use of the drug during the COVID-19 pandemic. Keep in mind that immunosenescence in older adults has among its most serious effects limiting the ability of their immune system to cope with viral respiratory infections. Precisely what SARV-Cov-2, the well-known coronavirus, did.
During the years of the pandemic, BMT was used extensively within the Cuban protocol for the treatment of the disease. In addition, it was tested in different risk population groups, which included people of all ages, with diseases such as high blood pressure, COPD (chronic obstructive pulmonary disease), diabetes mellitus, hypothyroidism, and ischemic heart disease.
In one of these investigations, carried out in a community in Matanzas, of the more than 1,200 people over 60 years of age treated with a BMT-based regimen, only 16 (1.3%) became ill and 1 (0.08%) died between April 12 and August 31, that is, during the most intense and highest mortality moments of the epidemic in our country.
This meant a 90% decrease in the incidence of symptomatic forms of the disease and mortality from COVID-19 compared to the national average. The results of this study appeared in the journal Current Therapeutic Research.
Subsequently, in 2022, two investigations that had the BMT at their center were awarded by the Cuban Academy of Sciences. The first of them addressed the immunomodulatory effect of BMT in institutionalized older adults, that is, those living in nursing homes and other care institutions. In the other study, results were obtained that suggest the feasibility of using BMT in older adults with cancer.
A path that “has just begun”?
It is difficult to think that a medicine that began research forty years ago and has had a health license for thirty years is just beginning its journey. However, in matters of science and technology, deadlines are not always short.
The long journey of BMT has brought it to a point where all the studies and its use during the COVID-19 health emergency indicate that it is not only safe but is capable of effectively modulating the immune system, especially in older adults, people with cancer, and children with poor thymus development. This seems to be its natural niche and that is where the latest research is being directed, with really good results.
On the other hand, the production of an injectable formulation on the island after years of testing with the homeopathic solution and the existence of government work based on science and innovation, a policy focused since 2020 on promoting biotechnological productions from the scientific and commercial point of view seems to have given a new lease of life to BMT, which according to a publication from the Cuban presidency went from being used in 35,000 patients in 11 years (from 2008 to 2019), to more than 235,000 during the pandemic, when the National Center for Biopreparations (BioCen) marketed nearly 2 million units of the medicine to the Ministry of Public Health (MINSAP).
Now it would be appropriate to extend it and, if possible, reach other markets, so that the promising drug can be tested and used by those who need it.
Author
Carlos Alberto González
