In 2014 the novel medication won a National Award from the Cuban Academy of Sciences (ACC) in the Biomedical Sciences arena, and since April, this year, the humanized monoclonal antibody, Itolizumab, has been included in the country’s COVID-19 treatment protocol.
To learn first-hand about the characteristics and indications of this drug, created at the Center for Molecular Immunology (CIM), and winner of the World Intellectual Property Organization (WIPO) Gold Medal in 2015, Granma spoke with Dr. Tania Crombet Ramos, director of Clinical Research at the institution, affiliated with the BioCubaFarma EnterpiseGroup.
-What is the monoclonal antibody Itolizumab?
Itolizumab is a molecule that was developed at the CIM for the treatment of lymphomas and leukemia. This antibody is able to block the proliferation and activation of t-lymphocytes, acting as an immunomodulator.
As part of its active mechanisms, it can reduce the secretion of a group of inflammation mediators, known as pro-inflammatory cytokines. In our country it had been used successfully in the treatment of patients with rheumatoid arthritis and psoriasis. Precisely, in clinical trials carried out in these autoimmune diseases, the monoclonal proved to be a very safe molecule, not causing adverse side effects in patients.
-What is called a cytokine storm?
According to various studies conducted around the world, a group of COVID patients develop an overactive immune reaction. To explain this in a simple way, after the elevated secretion of pro-inflammatory cytokines, blood vessels dilate to allow the immune cells to enter tissues, where viral replication must be reduced.
In some patients, a large outflow of substances and fluid occurs in the lungs and blood pressure drops. In order to stop the massive outflow of these substances, a coagulation cascade is activated, resulting in the obstruction of blood vessels in the lungs. This causes the patient great difficulty in gas exchange and hypoxia ensues. As pressure inside the lungs increases, heart failure can occur. Unfortunately, many patients die as a result of cardio-respiratory complications.
If other organs do not receive enough oxygen, permanent damage or even death may follow. The monoclonal antibody Itolizumab acts in the disease phase, when damage is caused by the immune system’s exaggerated response to the virus’ enormous ability to divide.
Thus, Itolizumab manages to reduce the secretion of these inflammatory cytokines, which cause the massive flow of substances and liquid in the lungs.
-What preliminary results have been obtained?
The monoclonal antibody has been used as part of an expanded protocol, approved by the joint scientific committee established by the Ministry of Public Health and the BioCubaFarma state enterprise group, for COVID-19. It was also approved by the Ethics Committee and by the Cuban regulatory agency, the State Center for the Control of Drugs, Equipment and Medical Devices (Cecmed). Thus far, more than 70 patients with the virus have been treated, in nine hospitals in Cuba.
“The main site of the investigation is the Manuel Piti Fajardo hospital in Santa Clara, where doctors and specialists are making very important contributions regarding the best time to use the monoclonal, as well as the best treatment regimen.
In particular, it has been used with patients in critical, serious and cautionary condition, at high risk for further complications. The best results have been seen in critically ill and cautionary patients, where the consequences of the cytokine storm are stopped in time. Likewise, in many cases there is clinical and imaging evidence of improvement in respiratory distress.
“We are currently engaged in the data collection and interpretation stage, so we can draw definitive conclusions, together with specialists in treatment and internal medicine,” the doctor added.
(Source: Granma)