Safety Evaluation Of GX1-rmhTNFα-a Fusion Protein Targeted To Gastric Cancer Vasculature

Gastric cancer is a common gastrointestinal malignancy,which threatens people?s lives in some serious cases. The current treatment is unfavourable. The recognition that angiogenesis is a key early event in tumor progression and metastasis has led to the development of new strategies for cancer therapy. This approach, in principle, has several advantages over traditional chemotherapy, including less toxicity and side effects, a general broad spectrum of activity, and a reduced risk for development of resistance.Preparation of GX1-rmhTNFαby Genetic Engineering Technology, which is a potent new antitumor drug with high antitumor effect and low toxicity.It could be significantly targeted to vascular endothelial in mice with SGC7901 cells and induce apoptosis in vascular endothelial cells. GX1-rmhTNFαcontributed to improve the effective concentration and suppress tumor growth.Aim: To determine the effect of GX1-rmhTNFαto the vital organs or systems the functions of are acutely critical for life, identify undesirable phamacodynamic properties of them, to observe the general pharmacology of polysaccharides from GX1-rmhTNFαexcept the main phamacodynamics, and then provided the experimental basis for human safety.Method:1. Mice given GX1-rmhTNFαfor injection respectively by tail iv, were determined the influence on cardiovascular, respiratory and central nervous system of animals.2. After the observations of undue toxicity text, anaphylaxis test and hemolysis text appreciate the safety of GX1-rmhTNFα.Results: The spontaneous activity and coordinated movement and pentobarbital sodium-induced hypnosis in mice were not obviously affected by the 3 doses of GX1-rmhTNFαinjection. The blood pressure and heart rate and respiratory system in mice have no obvious difference by the 3 doses of GX1-rmhTNFαinjection(p>0.05). The results of undue toxicity text, anaphylaxis test and hemolysis text were negative.Conclusion: The drug has no effects on nervous, cardiovascular and respiratory systems of the animals. It is comparatively safe as well as it has seldom poisonous effect.