Scios Nova has started a Phase I/II trial of its recombinant basic fibroblast growth factor product, Fiblast (trofermin), as an intravenous therapy for patients suffering an acute stroke. The study will enroll approximately 30 patients and will be conducted at several US centers.
bFGF has been shown to protect neurons from the damaging effects of an ischemic stroke, including oxygen and glucose deprivation. In addition, there is evidence that bFGF can protect these cells from substances released from stroke-affected neurons, including the neurotransmitter glutamate, that lead to a cascade of cell death around the lesion site. "In extensive preclinical animal studies, bFGF significantly reduced the amount of damaged tissue in numerous models of acute stroke," said the company in a statement. Some of this data has been published in Stroke and the Journal of Cerebral Blood Flow and Metabolism.
Fiblast is the third drug from Scios Nova's in-house research programs to enter the clinic, after Auriculin (anaritide) for oliguric renal failure (Phase III) and Natrecor (brain natriuretic peptide) for acute congestive heart failure (Phase II; Marketletters passim).
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