Effects of two formulations containing the IFN a2b and IFN g on the main clinical, hematological and biochemical parameters in non-human primates from Chlorocebus aethiops sabaeus species

Interferons (IFNs) are peptides with antitumoral action, widely used for the treatment of many diseases of oncologic origin. New evidences on the effect of a combination of IFN a2b and IFN g led to the formulation, CIGB 128, containing both IFNs. A variant, CIGB 128-A, was generated through excipient optimization, to reduce the number of administrations and the undesirable effects of the product. In this study, the effects of both products, CIGB 128 and CIGB 128-A, were evaluated attending to the behavior of clinical, hematological and biochemical parameters in Chlorocebus aethiops non-human primates. There were no clinical alterations on the body weight, major hematological parameters and the transaminases levels. The creatinine levels showed a slight decrease, related to the treatment with the formulations. These results provide new safety data on the effect of CIGB 128 and CIGB 128-A, supported by the unaltered main clinical, hematological and biochemical parameters in C. aethiops. They further indicate their potentially safe profile to test both formulations in humans.