BIOMODULINA ®T, health safety and efficacy
It is an injectable, non-haemoderivative, biological immunomodulator that is applied intramuscularly and intravenously. It is of natural origin and is composed of specific fractions of polypeptide bovine thymus.
Produced since 2008 at the National Center for Biopreparations (BioCen), part of the Biotechnology and Pharmaceutical Industries Group (BioCubaFarma). It has been registered in Cuba since 1994 and is indicated for conditions of immune dysfunction, especially of a cellular nature, associated with the gradual deterioration of the immune system caused by ageing: the so-called immunosenescence process.
The use of this medicine has basically been in the treatment of recurrent respiratory infections in older adults with excellent results in terms of efficacy and safety.
The administration of BIOMODULINA ® T is a promising strategy for immune restoration in elderly patients and the improvement of immunotherapeutic potential in people with cancer. It also has extensive possibilities for use in other immunodeficiencies or immunopathologies.
A phase III clinical trial promoted by BioCen and conducted at the Institute of Hematology and Immunology, under the auspices of the National Clinical Trials Coordination Center (CENCEC), is currently underway in children with thymic hypoplasia, related or unrelated to cellular immunodeficiency.
There is also another phase II-III clinical trial underway aimed at evaluating the efficacy and safety of BIOMODULINA ® T as a complementary therapy to antiretroviral treatment in patients with HIV/AIDS.
The greater vulnerability to the new coronavirus in elderly people and the presence of clinical symptoms of respiratory distress with fatal consequences, and taking into account the results of BIOMODULINA ® T in treating repetitive respiratory diseases, led to the medicine’s inclusion in the protocols to combat COVID-19, from a preventive scenario.
BIOMODULINA ® T has been administered to nearly 9000 elderly adults in 153 nursing homes and 26 psycho-educational medical centers with excellent results in terms of efficacy and safety.