Double-Blind Randomized Phase I Study on the Clinical Tolerance and Biological Effects of Natural and Recombinant Interferon-β

Abstract

The clinical tolerance of and the effects recombinant human interferon-β (rHuIFN-β) obtained from mammalian cells (Chinese hamster ovary cells) exerts on 2′,5′-oligoadenyl (2-5A) synthetase activity, human-Mx protein, neopterin, β₂-microglobulin, interleukin-1 (IL-1) α and β synthesis were compared to those of natural IFN-β in 12 healthy volunteers. Each subject received a single i.m. injection of 6 × 10⁶ IU rHuIFN-β and natural IFN-β according to a randomized double-blind cross-over study design. Both were well tolerated and provoked similar changes in clinical indices. Moreover, rHuIFN-β and natural IFN-β induced significant and similar increases in 2′-5′ adenylates, human Mx protein, and neopterin levels, but neither modulated β₂-microglobulin, IL-1 α or β synthesis. The sum of these findings indicates that rHuIFN-β and natural IFN-β are biologically equivalent. In view of these results, we are of the opinion that these two types of IFN are probably also therapeutically equivalent and, in consequence, that trials to evaluate the response of viral and neoplastic disease patients to rHuIFN-β are fully justified.