Effect of blockade of the EGF system on wound healing in patients vaccinated with CIMAvax® EGF.

BACKGROUND: The epidermal growth factor receptor (EGFR) signaling system is frequently unbalanced in human malignancies due to increased ligand production, receptor overexpression, receptor mutations, and/or cross-talk with other receptor systems. For this reason, the EGFR is an attractive target for anticancer therapy. The epidermal growth factor also plays an important role in regulating multiple facets of cutaneous wound healing, including inflammation, wound contraction, proliferation, migration, and angiogenesis. In the Center of Molecular Immunology, a cancer vaccine is produced (CIMAvax® EGF) that blocks the binding of EGF to its receptor. This blockade causes a significant inverse association between the anti-EGF antibody titers and EGF concentration. Around 1,500 patients with non-small cell lung cancer have been treated, showing that this vaccine is safe, immunogenic, increases survival and improves quality of life. Taking into account the therapeutic benefits of CIMAvax® EGF vaccination and the role of EGF-EGFR system in the wound healing process, we decided to conduct a retrospective research with the aim of determining the effect to the CIMAvax® EGF vaccine on the wound healing process in patients undergoing surgical treatment. METHODS: Medical records of 452 vaccinated patients were reviewed and only six patients receiving surgical treatment were identified. Further information about these six patients was obtained from source documents, including medical records and operative reports using an observational list that included different variables. Post-surgical wound healing complications were identified using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTC) version 3.0. RESULTS: None of the six patients operated on presented adverse events related to the wound healing, that is to say, no wound dehiscence, wound infection, delayed wound healing, fistula formation, abscess formation or hemorrhage/bleeding associated with surgery during treatment with CIMAvax® EGF occurred. CONCLUSIONS: These results suggest that the use of CIMAvax® EGF does not produce a deleterious effect in the wound healing process.

Pharmacokinetic Evaluation of Nimotuzumab in Patients With Autosomal Dominant Polycystic Kidney Disease.

Autosomal dominant polycystic kidney disease (ADPKD) is a genetic disease characterized by an overexpression and mislocalization of epidermal growth factor receptor (EGFR) to the apical membranes of cystic epithelial cells. Nimotuzumab is a humanized antibody that recognizes an extracellular domain III of human EGFR. The aim of this study was to assess the pharmacokinetic behavior of nimotuzumab in patients with ADPKD given as a single dose. A phase I, single-center, and noncontrolled open clinical study was conducted. Five patients were enrolled at each of the following fixed-dose levels: 50, 100, 200, and 400 mg. Intravenous continuous infusions of nimotuzumab were administered every 14 days during a year, except the first administration, when blood samples were drawn during 28 days for pharmacokinetic assessments. Subjects were closely monitored during the trial and at completion of the administration of nimotuzumab, including the anti-idiotypic response. For the first time, nimotuzumab was used for treating a nononcological disease. The administration of nimotuzumab showed dose-dependent kinetics. Nimotuzumab does not develop anti-idiotypic response against the murine portion present in the hypervariable region of the antibody present in the serum of the patients treated. No significant differences were found in the systemic clearance between the 100- and 400-mg dose, which indicates that the optimal biological dose is in this range of dose.

Aula virtual de Estadística en soporte multimedia / Statistics virtual clasroom in multimedia

El proceso de enseñanza-aprendizaje en el área de la Estadística experimenta una mejoría con las prácticas en los sistemas estadísticos. En algunas ocasiones las carreras universitarias que incluyen asignaturas relacionadas con la Estadística no tienen concebido en su Plan de Estudios prácticas con sistemas Estadísticos, y en otros, estas no son suficientes para desarrollar las habilidades prácticas que requiere esta disciplina. De modo general, las limitaciones materiales condicionan la ausencia total o parcial de actividades prácticas. El creciente desarrollo de las Tecnologías de la Información y la Comunicación (TIC) ha brindado la posibilidad de suplir estas carencias, con el desarrollo de Multimedias Interactivas y Aulas Virtuales. Este proyecto incluye un conjunto de Prácticas de Estadística en soporte Multimedia, que tienen como objetivo preparar al estudiante para obtener el máximo rendimiento en los sistemas estadísticos. Este producto puede ser utilizado como sustituto del Aula real en aquellos casos en que por razones de tiempo, espacio, la práctica real no sea posible(AU)

The process of teaching and learning quality in the area of statistics is determined largely by the good clinical practices. Sometimes university courses that include subjects related to Statistics are not viewed in its practical curriculum statistical system, and in others, these are not sufficient to develop the practical skills required for this discipline. In general, the material constraints condition the total or partial absence of practical activities. The increasing development of Information Technology and Communication (ICT) has provided the possibility of filling these gaps, with the development of Interactive Multimedia and Virtual Classrooms. This project includes a set of Practice of Statistics in multimedia, which aim to prepare the student to obtain maximum performance in statistical systems. This product can be used as a substitute for real classroom in those cases where for reasons of time, space, actual practice is not possible(AU)

Mejoras en el acceso a la información de los ensayos clínicos / Improved access to clinical assay information

El Centro de Inmunología Molecular ha venido desarrollando biomoléculas para el tratamiento del cáncer. En la medida que se avanza en el desarrollo de estos productos, se avanza en las fases I, II, III y IV de los ensayos clínicos, lo que trae aparejado un incremento en el número de pacientes a tratar y en el número de hospitales involucrados. Se cuenta con diez productos diferentes, implicados en más de 50 ensayos clínicos, nacionales y multinacionales, con un pronóstico de inclusión de 2 500 pacientes nuevos por año. En este proceso están incluidos alrededor de 30 hospitales en 13 provincias del país. Para mejorar el acceso a la información de ensayos clínicos por parte de los investigadores comprometidos, se creó un sitio Web formado por cuatro secciones fundamentales, relacionadas con los productos y sus indicaciones, buenas prácticas clínicas, la entrada remota de datos y la gerencia de los ensayos clínicos. Todo lo anterior mejora fundamentalmente la calidad de la información brindada a los investigadores clínicos involucrados y redunda en una mayor organización de la compleja actividad de los ensayos clínicos en Cuba

The Molecular Immunology Center has been developing biomolecules for cancer treatment. As the development of such products continues, phases I, II, III and IV of clinical assays also advance, which leads to an increase of the number of patients to be treated and the number of involved hospitals. There are ten different products involved in over 50 national and multinational clinical assays in which 2 500 patients are predicted to be included every year. Approximately 30 hospitals from 13 provinces are included in this process. For the purpose of improving the access of committed researchers to the clinical assay information, a new Website with four sections was devised. Those sections are related to products and their indications, good clinical practice, remote data entry and clinical assay management. All the above-mentioned improves the quality of the information given to involved clinical researchers and results in better organization of the complex activity of clinical assays in Cuba