Ph II Oxycyte trial delayed till 2nd qtr
USA-based oxygen therapeutics specialist Synthetic Blood International says that, subject to availability of future funding, it expects to initiate the Phase II trial of Oxycyte, its candidate treatment for sickle cell anemia, in the second quarter of this year.
The evaluation has been delayed after the firm received a letter from the US Food and Drug Administration placing it on hold for protocol revisions.
Robert Nicora, chief executive of the California-headquartered firm, said that "based on discussions with this trial's clinical investigators, we are confident in our ability to respond to issues raised by the FDA. We plan to quickly submit a revised protocol and consent that will enable us to proceed with this important study."
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