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Itolizumab Phase 3 Clinical Trials to Begin in US, Mexico and Brazil

The Center of Molecular Immunology (CIM) has collaborated with India's Biocon in the production of Itolizumab, a monoclonal antibody for patients with serious COVID-19.

Itolizumab, a monoclonal antibody developed by the Center of Molecular Immunology (CIM) in collaboration with Biocon, India’s largest pharmaceutical company, received authorization to begin Phase III clinical trials in patients with COVID-19 in the United States, Mexico and Brazil.

According to specialists who have used the immunoregulatory molecule for severe COVID-19 patients, 60% recover their respiratory function and are no longer in serious condition.

The studies carried out with Itolizumab, a humanized monoclonal antibody, demonstrate that the (anti-CD6) recognizes the human CD6 molecule in the malignant peripheral mononuclear cells of patients with chronic lymphocytic leukemia-B and in the lymphocytes of cutaneous lesions of patients with cutaneous T-cell lymphoma.

In the treatment of cytosine release syndrome associated with COVID-19, Itolizumab proved to be safe. There was no increase of bacterial infection due to the use of this product and there are no reports related to immunosuppression. The ventilatory function was notably improved.

Itolizumab reduced the risk of death in serious patients, compared to control patients with the same degree of severity of the disease. The effect was more marked in severe patients. In addition, in care patients, treatment with Itolizumab reduced the probability of transiting to critical condition.

Itolizumab was developed at CIM for the treatment of lymphomas and leukemias and is capable of blocking the proliferation and activation of T-lymphocytes.

In summary, Itolizumab demonstrated the capacity to improve the ventilatory parameters in severe and critical patients with COVID-19. It also decreases the high initial concentrations of Interleukin 6, which suggests its potentiality to control the cytosine release syndrome that occurs in this disease. Likewise, it was demonstrated that its use in aged patients with multiple comorbidities does not mean an additional risk for patients’ health.

The CIM is a biotechnology institution that focuses its research, development and manufacture of products for the treatment of cancer and other autoimmune diseases.

CIM has earned the recognition of the international scientific community. In 2014, it garnered the national prize from the Academy of Sciences of Cuba. In 2015, it was awarded the Gold Medal of the World Organization of Intellectual Property.

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Since April, Itolizumab has been a part of the medical care protocol for COVID-19 in Cuba. The monoclonal antibody drug remains one of the most effective in the treatment of serious COVID patients.

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