(Reuters) - Blood-safety products maker Cerus Corp said an U.S. advisory committee recommended more stringent safety margins for a late-stage trial of its intercept blood system to treat platelets.
“The more stringent safety margins recommended by the committee may require a clinical trial with a larger number of patients than had been proposed,” Chief Executive Claes Glassell said.
It will take at least 12 months to complete the trial preparations and partnering arrangements necessary for commencement of the potential trial, the company said.
However, the U.S. Food and Drug Administration’s Blood Products Advisory Committee supported further development of the product, the company said.
Cerus’ Intercept system inactivates blood-borne pathogens such as viruses, bacteria and parasites in blood components that are intended for transfusion.
Shares of the company closed at $2.56 Monday on Nasdaq.
Reporting by Anand Basu in Bangalore; Editing by Jarshad Kakkrakandy