Havana, Jul 27.- The Center for the State Control of Medicines, Equipment and Medical Devices (Cecmed) has released the authorization for the emergency use of the monoclonal antibody Itolizumab in the treatment protocol for critically ill patients of Covid- 19.
The product beat the preclinical stage of its research and proved to be safe for use in humans, in diseases such as psoriasis, multiple sclerosis, and rheumatoid arthritis, which have a mechanism and behavior similar to Covid-19.
The picture of cytokine storms produced by the disease caused by the new coronavirus decreases considerably and patients improve their ventilator capacity, the information revealed.
It is the first monoclonal antibody created by the Center for Molecular Immunology (MIC) in 1995. Originally it was used to treat certain types of cancer and as a result of the pandemic, research began on the possible effect that these cells could have in the treatment of Covid -19.
According to Doctor of Science Kalet Monzón, deputy director of the CIM, this authorizes us to use it in Cuban protocol and opens the door for it to be used in other countries. "This result will revitalize the research we are doing on this product and we are very happy to be able to achieve this achievement," he said.
Itolizumab was introduced into the protocol for Covid-19 in April 2020 for the treatment of critically ill and critically ill patients, and the research was later modified and used in moderate patients.
As explained by Dr. Tania Crombet, clinical director of the CIM, the results with this product are very significant in reducing mortality data. In severe patients, she said, the recovery rate was higher than 80% and in the case of moderate or cared patients with a high propensity to worsen their clinical picture, more than 95% recovered successfully.
The product, which is a significant contribution to the treatment of sick patients by Covid-19, is not only the result of the CIM but also from several research sites, intensive therapies, and clinicians in 10 hospital institutions, with a prominent position in the Manuel hospital. "Piti" Fajardo, from Villa Clara
Its registration is not only based on the results in Cuba, but in a controlled trial conducted in India, which confirmed the data from our country and with its use decreased mortality in that country. The regulatory authority of India has also authorized the use of this monoclonal antibody.
Itolizumab was started in six trial hospitals in India in clinical trials to validate its results in patient care with Covid-19.
As explained previously by Dr. Belinda Sánchez Ramírez, biochemist and director of Immunobiology at the CIM :, Itolizumab “is an antibody that recognizes the CD6 molecule in the T lymphocyte, inhibiting its activation, with an anti-inflammatory function.
“Today it is known that Covid-19 has a particularity and that is that the necessary activation of the immune system to fight the virus in a relatively short period, is sometimes followed by a lack of control of said activation. It is, then, the exacerbated immune response, manifested in a storm of inflammatory cytokines, that influences the passage to severity / criticality of patients. Hence, there are different therapies that should be used at the beginning of the disease, to those that should be used when the patient crosses into a more serious condition. " (Taken from Cubadebate) (Photo: ACN)