Resumen

BERLANGA, Jorge. Heberprot-P: experimental background and pharmacological bases. Biotecnol Apl [online]. 2010, vol.27, n.2, pp. 88-94. ISSN 1027-2852.

Heberprot-P is a novel drug intended to solve an unmet medical need: to heal high -grade, poor-prognostic ulcers which affect lower limbs of diabetic patients. The human recombinant epidermal growth factor (hrEGF) is the active pharmaceutical ingredient of Heberprot-P. EGF is a highly evolutionarily conserved polypeptide playing a significant role on the intra and extra-uterine life in mammals. Based on the early findings of its epitheliotropic and mitogenic effects, it was prematurely intended as healing agent for problematic wounds. Our Center for Genetic Engineering and Biotechnology manufactures (EGF) since 1988. About 1991, we unleashed an intense experimental research program on in vivo systems which somewhat mirrored a variety of human pathological conditions . Those studies accounted for the identification of novel pharmacological effects associated to the systemic or parenteral administration of EGF. Henceforth it enabled us to envision new therapeutic indications to treat processes requiring cytoprotective effects. We had demonstrated since 1995, that the local infiltration of EGF in the hindlimbs of rats, mitigated the degenerative process on peripheral nerves and soft-tissues undergoing the consecuenses of denervation. Further studies evidenced the ability of EGF to rescue tissues and organs from death by ischemia/reperfusion events, and also in models of multiorgan damage under acute preconditioning or therapeutic schedules. During that decade, we demonstrated the need to preserve EGF from the action of proteases released in full-thickness controlled wounds. All these aspects were pieces of knowledge supporting the hypothesis on the beneficial effect of the intralesional infiltration of EGF to rescue and perpetuate cells in diabetic ulcers ensuring an appropriate local bioavailability.

Palabras clave : Epidermal growth factor; Heberprot-P; wound healing; diabetic foot ulcer; cytoprotective; preclinical; toxicology.

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