Developing of pharmaceutical formulation that combines the interferons alpha-2b and gamma for the treatment of non-melanoma skin cancer
Keywords:
carcinoma basocelular, interferón, farmacodinamia, pacientesAbstract
Introduction: It is needed a more potent and safer formulation of interferons for cancer treatment. This can be achieved using the synergism between interferons.
Objetive: To identify the sinergistic proportion of concentration of the interferons α-2b and -g as well as the clinical evaluation of the resulting combination of interferons.
Methods: It was studied the synergistic antiproliferative effect by isobologram analysis in tumor cell cultures incubated with interferons. The evaluations were in animal models and patients. They were approved the clinical studies by the ethics committees and the patients gave their informed consent to participate. They were included more than 200 patients with a histological diagnosis of non-melanoma skin cancer. They were administered interferons peri-intralesionally, 3 times a week for 3 weeks. They were evaluated clinical and histological responses 3 months after the end of treatment by RECIST (Response evaluation criteria in solids tumors).
Results: Antiproliferative studies identified different synergistic proportions of interferons α-2b and -γ. In animals the antitumor effect was significant. The pharmacokinetic evaluation confirmed similarity for both interferons and the pharmacodynamic variables were strongly stimulated. In patients with non-melanoma skin cancer there were faster and greater complete responses. They were obtained 47% complete responses and 40% partial responses in advanced skin carcinomas, maintained for more than 2 years. The application in periocular tumors achieved a curative and aesthetic effect. It was approved the combination of interferons α-2b and -γ in patients with basal cell carcinoma by the Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos of Cuba (Center for state control of medicines, equipment and medical devices).
Conclusions: The rational combination of interferon α-2b and -γ resulted in a new formulation of interferons that offers a promising alternative for the treatment of cancer with a very favorable safety profile.
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