Journal of Clinical Trials
Open Access

Lina Pérez

Publications

• Research Article
  Phase I Clinical Trial with a Novel Altered Peptide Ligand Derived from Human Heat-Shock Protein 60 for Treatment of Rheumatoid Arthritis: Safety, Pharmacokinetics and Preliminary Therapeutic Effects
  Author(s): Dinorah Prada, Jorge Gómez, Norailys Lorenzo, Oreste Corrales, Ana López, Evelio González, Ania Cabrales, Yusimy Reyes, Yuliet Bermudez, Yisel Avila, Lina Pérez, Claudio Molinero, Osmel Martinez, Leonardo Oramas, Yaysel Miñoso, Yassel Ramos, Hilda Garay, Ever Pérez, Matilde López, Osvaldo Reyes2, Yolan Dinorah Prada, Jorge Gómez, Norailys Lorenzo, Oreste Corrales, Ana López, Evelio González, Ania Cabrales, Yusimy Reyes, Yuliet Bermudez, Yisel Avila, Lina Pérez, Claudio Molinero, Osmel Martinez, Leonardo Oramas, Yaysel Miñoso, Yassel Ramos, Hilda Garay, Ever Pérez, Matilde López, Osvaldo Reyes2, Yolan
  
  Background: CIGB 814 is an Altered Peptide Ligand (APL) from a CD4+ T-cell epitope of human heat shock protein 60 (HSP60), an auto-antigen involved in the pathogenesis of rheumatoid arthritis (RA). It induced mechanisms associated with restoration of peripheral tolerance in preclinical studies. This clinical trial was conducted to assess safety and pharmacokinetics (PK) of CIGB-814 in patients with RA. Method: 20 patients with moderated active RA were included in an open label trial. Sequential dose-escalation of 1, 2.5 and 5 mg of CIGB-814 was studied. Consecutive groups of six, five and nine patients received a subcutaneous dose weekly of the peptide during the first month and one dose monthly during the next five months. Clinical response in patients was evaluated according to the American College of Rheumatology (ACR) and Disease Activity S.. View More»
  DOI: 10.4172/2167-0870.1000339

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