A first-in-class, first-in-human, phase I trial of CIGB-552, a synthetic peptide targeting COMMD1 to inhibit the oncogenic activity of NF-κB in patients with advanced solid tumors.

CIGB-552 is a synthetic peptide that interacts with COMMD1 and upregulates its protein levels. The objectives of this phase I study were safety, pharmacokinetic profile, evaluation of the lymphocytes CD4+ and CD8+ and preliminary activity in patients with advanced tumors. A 3 + 3 dose-escalation design with seven dose levels was implemented. Patients were included until a grade 3 related adverse event occurred and the maximum tolerated dose was reached. The patients received subcutaneous administration of CIGB-552 three times per week for 2 weeks. Single-dose plasma pharmacokinetics was characterized at two dose levels, and tumor responses were classified by RECIST 1.1. Twenty-four patients received CIGB-552. Dose-limiting toxicity was associated with a transient grade 3 pruritic maculopapular rash at a dose of 7.0 mg. The maximum tolerated dose was defined as 4.7 mg. Ten patients were assessable for immunological status. Seven patients had significant changes in the ratio CD4/CD8 in response to CIGB-552 treatment; three patients did not modify the immunological status. Stable disease was observed in five patients, including two metastatic soft sarcomas. We conclude that CIGB-552 at dose 4.7 mg was well tolerated with no significant adverse events and appeared to provide some clinical benefits.

Efficacy and safety of iorEPOCIM for chemotherapy- or radiotherapy-induced anemia in pediatric cancer patients.

INTRODUCTION: Recombinant human erythropoietin (RHuEPO) is an erythropoiesis stimulating agent (ESA) used to treat anemia in patients with total or relative erythropoietin deficit. In cancer patients, it is administered to optimize hemoglobin (Hb) levels, correct anemia and reduce the need for transfusions. Cuba produces a RHuEPO, registered in 1998 as iorEPOCIM, that is widely used in the national public health system, mainly to treat patients with anemia due to chronic kidney disease (CKD). OBJECTIVE: Evaluate the efficacy and safety of iorEPOCIM in pediatric cancer patients with anemia following chemotherapy or radiotherapy. The working hypothesis posed an Hb increase>or=15 g/l in 70% of patients receiving iorEPOCIM for 8 weeks. METHODS: A Phase IV, multicenter, open clinical trial was conducted. Participants were 157 patients aged 1-19 years with anemia and cyto-histological diagnosis of cancer in any location. Patients received either 600 U/kg iorEPOCIM intravenously, once weekly, or 150 U/kg iorEPOCIM subcutaneously, 3 times a week, for 8 weeks. All patients had blood tests every week to determine hemoglobin and hematocrit, and reticulocyte and platelet counts. Mean number of transfusions required by patients during the treatment period was compared to the mean number of transfusions received in the preceding 8 weeks. Adverse events (AE) were recorded at the 4th and 8th weeks and classified by intensity and causality. RESULTS: Hb levels rose>or=15 g/l in 68.8% of patients, and transfusion requirements decreased 17%. The most frequent adverse events were fever (19.3%), vomiting (10.2%) and flu-like syndrome (9.6%). Intensity of AE was predominantly mild. Only 7 AE were classified as very probably related to the product and none of those was severe. CONCLUSIONS: iorEPOCIM proved to be safe and effective at the doses and frequencies used in this patient population. As a result, this medication was recommended for use in all pediatric oncology and hematology services in the country.

Posta de Salud Stella Maris: una apuesta por un modelo de atención más humano, integral y democrático / . Stella Maris post health: A commitment for a more human, more integrative and more democratic care model

Posta de Salud Stella Maris es un dispositivo de cuidados en domicilio, que trabaja pensando la accesibilidad como encuentro entre usuarios, donde lo vincular supera otras barreras. Hemos puesto a las personas delante de las enfermedades, acercando un plan de cuidados integral para las familias en sus hogares y su barrio. Trabajamos desde 2012 en el barrio Stella Maris. Cuentan con un hospital interzonal y tres unidades sanitarias en un radio de 1 km. Los vecinos describen dificultades para acceder a la atención dado el gran tamaño poblacional, que es de 370 familias. La posta realiza visitas domiciliarias de primer contacto y de Seguimiento familiar. Además, se llevan a cabo jornadas especiales de promoción de la salud. Creemos que hemos podido revalorizar la visita domiciliaria y el espacio en el barrio como espacio de trabajo de los equipos de salud del como lugar más idóneo que el centro de salud para abordar el Proceso Salud Enfermedad.

The Stella Maris post health care is a device that works at home thinking about accesibility as the meeting betwen health workers and users, where linking it overcome the barriers of accessibility. We had put the people before disease, approaching a plan of integral cares in their home and in their neighborhood. Since 2012 we are working in Stella Maris neighborhood, where we canfind an intezone hospital and three health units around a mile. Neighbors decribed difficuties in accesing the care given to the large population size, that is 370 families. The post makes home visits and familiy first contact monitoring. The post also conducts special sessions of health promotion We believe we could reassess the home visits and the space in the neighborhood as workspace health team as more appropriate that the health center place to address the process of health - disease.

Eficacia y seguridad del OLEOZON tópico en el tratamiento de pacientes con impétigo / Efficacy and security of topical OLEOZON in the treatment of patients with impetigo

Se realizó un ensayo clínico fase III, multicéntrico, abierto, paralelo, aleatorizado y controlado, para evaluar la eficacia y seguridad del OLEOZON® tópico (aceite de girasol ozonizado) en el tratamiento de pacientes con impétigo. Se conformaron 2 grupos: uno tratado con OLEOZON® y otro con crema de Mupirocina 2%. Ambos tratamientos se aplicaron de forma tópica, 3 veces al día hasta la cura de las lesiones o hasta un máximo de 10 días. Se incluyeron 136 niños de 0 a 14 años de edad con diagnóstico clínico y bacteriológico de impétigo, vírgenes de tratamiento o con al menos 72 horas sin tratamiento específico tópico o sistémico y con el consentimiento de sus padres. Para determinar la eficacia se realizó la prueba unilateral de equivalencia de las proporciones a la variable principal del estudio: respuesta clínica. La seguridad del tratamiento fue evaluada a través del tipo e intensidad del evento adverso. De acuerdo al análisis realizado la proporción de pacientes curados clínicamente en el grupo OLEOZON® no resultó inferior en un 20% a la proporción de pacientes curados en el grupo de Mupirocina, por lo que se consideran tratamientos equivalentes. Un 92.9% (39/42) de los pacientes del grupo OLEOZON® curaron, mientras que en el grupo de Mupirocina el 100% de los pacientes (59/59) lograron igual respuesta. Ambos tratamientos resultaron ser seguros a las dosis según el esquema de administración aplicados en el estudio.