Batimastat preclinical study

A total of five animal studies, ranging from five days to three months implantation, have been conducted with the batimastat-loaded Biod/VYs/o Stent (Fig. 2). A summary of the preclinical studies is shown in Table 2. In all the animal studies, batimastat was loaded on either the Biod/VYs/o AS or OC stents since these stents are more applicable to the vessel size of the selected animal models. 

Scanning electron micrograph showing continuous endothelial cell coverage of the stent struts after five-day implantation (preclinical study of clinical trial dose BiodivYsio Batimastat Stent). 

In addition to the preclinical studies, the clinical studies demonstrate that stent-based delivery of batimastat in coronary artery using the Biod/VYs/o DD stents is a feasible and safe procedure. Results from the BRILLIANT study however did not show a positive effect of the BiodivYsio Batimastat OC stent on TLR, late loss, and binary restenosis. 

De Scheerder I, Xianshun Liu, Chevalier B, LeClerc G, Colias A. Batimastat mode of action, preclinical and clinical studies. In Camenzind E, De Scheerder I, eds. Local Drug Delivery for Coronary Artery Disease. London and New York Taylor Francis, 2005 483-498. 

The five-day, one-, and three-month preclinical data are available for PC-stents loaded with the CTD of batimastat. Histological analysis showed that the degree of fibrosis, hemorrhages, and inflammatory cell infiltration was not significantly different between the control and CTD stents at all three time points. Five-day and one-month data are available for stents containing greater than three times the CTD. Taken together, these studies demonstrate that the Biod/VY s/o Batimastat Stent is well tolerated in appropriate animal... 

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