J.Jpn. Surg. Soc.. 88(9): 1105-1108, 1987

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Report on the annual meeting

CLINICAL TRIAL OF OH-1 (NATURAL HUMAN TNF-α AND NATURAL HUMAN IFN-α) ON PRIMARY AND RECURRENT CANCERS

The results of basic and clinical evaluation on OH-1 (nHuTNF-α plus nHuIFN-α) are reported. Basic studies confimed that the combination of nHuTNF-α and nHuIFN-α synergistically augment their anti-tumor activities dose-dependently. The substances act via their respective receptors and exhibit their antitumor activities dependent on the cell cycle of tumor cells. Side effects commonly observed during phase I trial were fever, chills, anorexia and general fatigue, but were all of slight degree. The efficacy rate attained in early phase II trial was 12.9%. With the effective dose of over 200 × 10⁴u/body one case of CR and three cases of PR were attained in breast cancer patients, efficacy rate of 23.5% ; three PR cases in hepatocellular carcinoma patients, efficacy rate of 25.0% ; three cases of PR in renal cellcarcinoma, efficacy rate of 42.9% ; and one case of PR in patient of ovarian cancer, mediastinal carcinomaor liposarcoma. One case each of gastric cancer, breast cancer, lung cancer or rhabdomyosarcoma showed MR. The present trial is the first clinical trial in the world on the combined use of nTNF-α and nIFN-α. The results suggest the potential use of cytokines in cancer therapy.

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