Expanded trial set for blood substitute
The Food and Drug Administration recently asked Evanston, IL-based Northfield Laboratories to expand the number of patients in Phase III clinical trials of PolyHeme, the company’s blood substitute.
The FDA based its request on public concern over failures of competing products in Phase III trials. The protocol cleared earlier by the FDA included 240 elective surgery patients. The latest agreement, however, calls for a minimum of 600 patients to participate in the expanded study.
In the two years of the Phase III trial, PolyHeme has been infused in more than 100 patients without negative side effects, including infusions at a dose level of up to ten units. The company notes that the expansion of the Phase III trial will likely delay completion until late spring of next year.
However, the FDA also has given Northfield the OK to infuse up to 20 units of PolyHeme in adults in Phase II trials being conducted among trauma patients.