Pre-clinical efficacy and safety pharmacology of PEGylated recombinant human endostatin
Introduction:
This study aimed to outline the pre-clinical efficacy and safety pharmacology of PEGylated recombinant human endostatin (M2ES) according to the requirements of new drug application.
background:
These studies aimed to outline the pre-clinical efficacy and safety pharmacology of PEGylated recombinant human endostatin (M2ES) according to the requirements of new drug application.
Method:
The purity of M2ES was evaluated by using silver staining. Transwell migration assay was applied to detect the bioactivity of M2ES in vitro. The antitumor efficacy of M2ES was evaluated in an athymic nude mouse xenograft model of pancreatic cancer (Panc-1) and gastric cancer (MNK45). BALB/C mice were treated with different doses of M2ES (6, 12 and 24 mg/kg) intravenously, both autonomic activity and cooperative sleep were monitored before and after drug administration. The apparent molecular weight of M2ES was about 50 kDa, and the purity was greater than 98%.
objective:
To investigate the pre-clinical efficacy and safety pharmacology of M2ES.
Result:
Compared with the control group, M2ES significantly inhibits human microvascular endothelial cells (HMECs) cell migration in vitro. Notably, weekly administration of M2ES showed a significant antitumor efficacy when compared with the control group. Treatment of M2ES (24mg/kg or below) showed no obvious effect on both autonomic activity and hypnosis.
method:
The purity of M2ES was evaluated by using silver staining. Transwell migration assay was applied to detect the bioactivity of M2ES in vitro. The antitumor efficacy of M2ES was evaluated in an athymic nude mouse xenograft model of pancreatic cancer (Panc-1) and gastric cancer (MNK45). BALB/C mice were treated with different doses of M2ES (6, 12 and 24 mg/kg) intravenously, both autonomic activity and cooperative sleep were monitored before and after drug administration.
Conclusion:
On the basis of the pre-clinical efficacy and safety pharmacology data of M2ES, M2ES can be authorized to carry out further clinical studies.
result:
The apparent molecular weight of M2ES was about 50 kDa, and the purity was greater than 98%. Compared with control group, M2ES significantly inhibits human microvascular endothelial cells (HMECs) cell migration in vitro. Notably, weekly administration of M2ES showed a significant antitumor efficacy when compared with the control group. Treatment of M2ES (24mg/kg or below) showed no obvious effect on the autonomic activity of mice, and had no significant synergistic hypnotic effect with the subthreshold hypnotic dose of pentobarbital sodium.
other:
no
Топ-30
Журналы
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Frontiers in Cell and Developmental Biology
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International Journal of Molecular Sciences
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Frontiers Media S.A.
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MDPI
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