Pedro López Saura

High levels of soluble IFN γ receptor α chain in the plasma of rheumatoid arthritis patients

Soluble receptors for hormones and cytokines have beendescribed. They can serve as natural blockers of theirrespective ligands. The natural soluble interferongamma receptor (sIFNγR) has been isolated andcharacterized only in urine. Chromatography of human(hu) plasma from rheumatoid arthritis (RA) patientsand controls on immobilized hu IFN γ orantibodies against IFN γ R α chainpermitted us to isolate the sIFNγR. Thereceptor isolated from one control is a protein witha molecular weight between 60-67 kDa depending on thepresence of reducing agents. We detected asignificantly higher level of plasma sIFNγR inpatients with rheumatoid arthritis than in apparentlyhealthy subjects.

Phase I Clinical Trial of the 131I-Labeled Anticarcinoembryonic Antigen CIGB-M3 Multivalent Antibody Fragment

Center for Genetic Engineering and Biotechnology (CIGB)-M3 is a trivalent recombinant single-chain Fv antibody fragment specific for carcinoembryonic antigen (CEA). Preclinical studies with radiolabeled CIGB-M3 have showed that the antibody fragment accumulates in human colon tumor xenografts growing in nude mice. A Phase I clinical trial was carried out to determine safety, biodistribution, and pharmacokinetics of the radiolabeled CIGB-M3 in two groups of patients with CEA+ colorectal cancers. Group I (10 patients) received a single intravenous injection of 0.3 mg of (131)I-CIGB-M3 (16.7-23.3 mCi/mg). Group II (7 patients) received 1 mg (5-7 mCi/mg). No adverse events related to the injected product were recorded, and no immunology response was detected up to 6 months after the injection. Tumors were detected in 15 of the 17 studied cases. The pharmacokinetic profile showed beta half-times of 14.1 and 6.3 hours for Groups I and II, respectively. Seventy-two (72) hours after the administration of the product, 85% of the total injected activity was excreted in urine in the form of free (131)I. The kidneys were identified as the organs that can limit the maximum tolerated dose. The (131)I-CIGB-M3 was safe in patients with colorectal cancer. The biodistribution and pharmacokinetic data suggest that the product can be further tested for molecular radiotherapy of CEA+tumors.

Uso de crema de interferón alfa leucocitario humano en condilomas acuminados

Antecedentes El interferon alfa (IFNα) es una terapia aprobada para las lesiones causadas por el virus del papiloma humano (VPH). Pacientes y metodo Se realizo un estudio a doble ciego, aleatorizado y controlado con placebo, en el que se incluyo a 76 pacientes infectados por el VPH que no presentaran mas de cinco lesiones de condiloma acuminado. Los pacientes fueron tratados con una formulacion topica de IFNα leucocitario humano (nIFN) o con una formulacion placebo, segun correspondiera en la lista aleatorizada; 25 pacientes recibieron, cuatro veces al dia durante 12 semanas consecutivas, una crema que contenia 100.000 U de nIFN/g (grupo I); 26, una crema de 20.000 I de nIFN/g (grupo II) y 26, la crema placebo (grupo III). Resultados La asociacion entre la evolucion clinica de las lesiones y la respuesta al tratamiento mostro que 22 (30,6%) pacientes quedaron libres de lesiones, 7 (30,4%) del grupo I, 10 (40%) del grupo II y 5 (20,8%) del grupo III. Se produjo una disminucion superior al 50% en el numero y el tamano de las lesiones en 3 (13%) pacientes del grupo I, 3 (12%) del grupo II y 2 (8,3%) del grupo III. Se considero no respondedores a 5 (21,7%) pacientes del grupo I, 9 (23%) del grupo II y 13 (54,2%) del grupo III, pues tuvieron una disminucion del numero y el tamano de las lesiones 25% del tamano y el numero de las lesiones, lo que se dio en 8 (34,8%) pacientes del grupo I, 3 (12%) del grupo II y 4 (16,7%) del grupo III. Conclusiones Los 30 (41,7%) de 76 pacientes que en que desaparecieron o se redujeron el numero y el tamano de las lesiones son un resultado prometedor en el control de los condilomas acuminados empleando IFNα en crema.

Effect of transfer factor on myelosuppression and related morbidity induced by chemotherapy in acute leukaemias

Summary. The aim of this study is to determine the safety and efficacy of Transfer Factor (TF) in accelerating the haematopoietic recovery in patients with acute leukaemias (AL), following intensive therapy to induce remission of the disease. Twenty‐two patients with different types of AL (16 AML, three BC‐CML and three ALL) were studied. The patients were divided in two groups. Group 1 (eight AML, two BC‐CML and one ALL) received, after myelosuppression induced by chemotherapy, TF (1 unit daily, subcutaneous) until leucocyte count was >2·5 × 109/1 and platelet count > 80 × 109/l. Group 2 was considered the control group and did not receive TF. Treatment with TF accelerated the recovery of neutrophils, leucocytes, platelets (P < 0·001. and haemoglobin (P < 0·01). As a logical consequence, incidence and severity of infection and haemorrhage were lesser in the TF group than in the control group. There was no evidence that TF accelerated the re‐growth of leukaemic cells. It seems that TF is safe in AL, accelerating haematopoietic recovery. However, it should be used with caution until results of additional trials become available.