carcinoma and pancreatoblastoma are histologically similar, both containing abundant acinar cell
In the pancreatic acini, the administration of a-difluoromethylornithine, an irreversible inhibitor of polyamine biosynthesis, blocks tissue regeneration [22, 23] and can cause pancreatitis , while appropriate polyamine synthesis is necessary for growth factors to affect pancreatic acinar cells
Aliquots of acinar cell
suspension (1 mL) were transferred to DMEM in culture dishes containing 100 Ci of [[sup.
These compounds have been shown to accumulate in rat pancreas and to cause acinar cell
damage in vitro by inducing lysosomal fragility (Haber et al.
The incidence of acinar adenoma in the 22-ng/kg group and the incidences of acinar carcinoma in the 10-ng/kg and 46-ng/kg groups exceeded the historical control ranges (overall incidence of acinar cell
adenoma, 1 of 207 or 0.
3) Other stains (such as trypsin and chymotrypsin for pancreatic acinar cell
carcinoma, chromogranin and synaptophysin for neuroendocrine neoplasms, and others) can be included in the panel, depending on the clinical information and the morphologic appearance.
Hydrolysis of triglycerides in the pancreas leads to unbound fatty acids in high concentrations, which are toxic and can cause acinar cell
and capillary injury.
The FDA concluded that a preclinical finding of pancreatic acinar cell
tumors in rats was of sufficient concern to preclude approval of the Horizant NDA for RLS in its current form.
While the agency did not raise any questions regarding the efficacy or the clinical safety of the drug, the agency was concerned about a preclinical signal of pancreatic acinar cell
tumors in rats.
Other differential diagnoses included acinar cell
carcinoma, solid pseudopapillary neoplasm, and, less likely, adenocarcinoma or lymphoma.
carcinoma and pancreatoblastoma--Other epithelial exocrine pancreatic tumors, such as acinar cell
carcinoma and pancreatoblastoma, are very rare; however, pancreatoblastoma is the most common pancreatic tumor in children.
GSK and XenoPort are currently evaluating the Complete Response letter, in which the FDA indicated that a preclinical finding of pancreatic acinar cell
tumors in rats was of sufficient concern to preclude approval of Horizant for RLS at this time.