Efectividad y seguridad del uso de ior® EPOCIM en pacientes en prediálisis Ensayo clínico

Introducción: El ior® EPOCIM (eritropoyetina humana recombinante), es un medicamento cubano que se produce en el Centro de Inmunología Molecular, el cual ha resultado ser seguro y no se han reportado eventos adversos graves asociados a su uso en pacientes dialíticos, sin embargo, en pacientes en prediálisis la información divulgada sobre su uso es insuficiente.Objetivo: Evaluar la efectividad y seguridad de ior® EPOCIM en pacientes con Enfermedad Renal Crónica en prediálisis, estadios 3 y 4.Material y Métodos: Se realizó un ensayo clínico multicéntrico, abierto, no aleatorizado, fase IV, que incluyó una muestra de 242 pacientes con y sin anemia.  Durante 12 meses se evaluó el tratamiento con iorâ EPOCIM, dosis inicial de 30 U/Kg/dosis e incrementó según respuesta hematológica hasta 150 U/Kg/dosis, para lograr estabilización de la hemoglobina entre 10,5-12,5 g/dl y/o hematocrito entre 33-36 %.Resultados: la hemoglobina inicial promedio fue 10 ± 1,5 g/dl, se incrementó progresivamente hasta el cuarto mes estabilizando su valor en 11,7 ± 1,2 g/dl y el hematocrito tuvo similar comportamiento. La función renal se mantuvo estable; la calidad de vida mejoró; hubo mayor beneficio en las escalas de rol físico y salud general. Se reportaron 147 eventos adversos; tuvieron alguna relación causal 13,6%. El evento más frecuente fue la hipertensión arterial. Ninguna muerte estuvo relacionada con el producto.Conclusión: El ior® EPOCIM fue seguro y efectivo en los pacientes estudiados con Enfermedad Renal Crónica en prediálisis, estadios 3 y 4. Palabras clave: Enfermedad renal crónica, prediálisis, ior®EPOCIM, eritropoyetina, anemia, ensayo clínico </p

Efficacy of nimotuzumab according to inflammatory indices in patients with advanced non-small cell lung cancer

Introduction: The response to therapies in advanced lung cancer could be related to certain prognostic factors such as inflammatory indices. Objective: To evaluate the efficacy of the humanized monoclonal antibody nimotuzumab in patients with advanced non-small cell lung cancer according to inflammatory indices. Method: A retrospective longitudinal evaluation study was carried out in a universe of 498 patients older than 18 years, with a cytohistological diagnosis of non-small cell lung cancer, in advanced stages, after the first line of oncological therapy, including in multicenter clinical trials promoted by the Center for Molecular Immunology from 2002 to 2018. Descriptive statistics were applied, the x-tile 3.6.1 software was used for the Kaplan Meier test, significant differences were considered when p< 0,05. Results: In the patients analyzed, nimotuzumab showed therapeutic benefit in the group of patients who did not progress to the first line of treatment with chemotherapy or chemoradiotherapy, when they had a lower neutrophil-lymphocyte index (p= 0,017 and p= 0,027) and a lower platelet-lymphocyte index (p= 0,030 and p= 0,009). Conclusion: Selecting a patient with a lower inflammatory index benefits the efficacy of treatment with the humanized mAb nimotuzumab in advanced non-small cell lung cancer, which becomes a predictive tool for response to treatment

Erythropoietin: from erythropoiesis to cardioprotection

Many of the drugs that has shown promise in the treatment of hematologic malignancies and solid tumors, associated with a high potential cardiotoxic. Within this group stand anthracyclines, identified as the type of chemotherapy most likely to cause heart damage, short or long term. With the improvement achieved in the survival of patients with these diseases, this adverse event has become a major concern for the scientific community. Although many agents have been evaluated as potential cardioprotective therapeutic, clinical data are limited and does not suggest that the use of these agents promotes the survival of patients undergoing cardiotoxic treatments. The identification of erythropoietin receptor in hematopoietic tissues, including the heart, as well as its marked cardioprotective effect during ischemia have led to the hypothesis that erythropoietin may be able to prevent anthracycline-induced cardiomyopathy. Addressing this hypothesis is the objective of this work

Security 1E10 anti-idiotypic vaccine in patients with tumors of different locations

Cancer is a leading cause of death in Cuba and the world. Lung cancer is the leading cause of death, breast cancer is the second leading cause of death and colorectal cancer is the third leading cause of death. The 1E10 anti-idiotype vaccine is a new immunotherapeutic agent, registered for lung cancer by the Center for Molecular Immunology (CIM). You want to evaluate the safety of this vaccine in the treatment of various cancer sites. To determine the safety adverse events occurred in six clinical trials (one stage I lung, 3 phase II in breast, colon and lung, 1 phase II-III and program expanded use, both in lung) were evaluated. 656 patients were studied. Demographic variables, the characteristics of the disease and adverse events were measured. The studies were balanced with respect to baseline characteristics. The most common adverse events were local reactions associated with 1E10 anti-idiotype vaccine and systemic reactions of mild or moderate intensity that were not related to the administration of the vaccine under study. The 1E10 anti-idiotype vaccine is safe for the low frequency and intensity of adverse events reported

Open-label phase I/II clinical trial of SARS-CoV-2 receptor binding domain-tetanus toxoid conjugate vaccine (FINLAY-FR-2) in combination with receptor binding domain-protein vaccine (FINLAY-FR-1A) in children

Objectives: To evaluate a heterologous vaccination scheme in children 3-18 years old (y/o) combining two SARS-CoV-2r- receptor binding domain (RBD)protein vaccines. Methods: A phase I/II open-label, adaptive, and multicenter trial evaluated the safety and immunogenicity of two doses of FINLAY-FR-2 (subsequently called SOBERANA 02) and the third heterologous dose of FINLAY-FR-1A (subsequently called SOBERANA Plus) in 350 children 3-18 y/o in Havana Cuba. Primary outcomes were safety (phase I) and safety/immunogenicity (phase II) measured by anti-RBD immunoglobulin (Ig)G enzyme-linked immunoassay (ELISA), molecular and live-virus neutralization titers, and specific T-cells response. A comparison with adult immunogenicity and predictions of efficacy were made based on immunological results. Results: Local pain was the unique adverse event with frequency >10%, and none was serious neither severe. Two doses of FINLAY-FR-2 elicited a humoral immune response similar to natural infection; the third dose with FINLAY-FR-1A increased the response in all children, similar to that achieved in vaccinated young adults. The geometric mean (GMT) neutralizing titer was 173.8 (95% confidence interval [CI] 131.7; 229.5) vs Alpha, 142 (95% CI 101.3; 198.9) vs Delta, 24.8 (95% CI 16.8; 36.6) vs Beta and 99.2 (95% CI 67.8; 145.4) vs Omicron. Conclusion: The heterologous scheme was safe and immunogenic in children 3-18 y/o. Trial registry: https://rpcec.sld.cu/trials/RPCEC0000037