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news.The Drug Controller General of India has given approval to Oxygen Biotherapeutics to organize a double-blind, placebo controlled dose-escalation STOP-TBI Phase IIb traumatic brain injury clinical trial in India.
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The STOP-TBI trial aims to investigate the safety, efficacy and dosing parameters of a novel perfluorocarbon emulsion, Oxycyte PFC that is given intravenously to traumatic brain injury patients.
The Indian Phase IIb traumatic brain injury trial is an add on trial to company’s existing clinical sites in Switzerland and Israel.
Oxygen chairman and CEO Chris Stern said currently, they are amending the protocol to include patients with milder forms of TBI, and they are developing the processes for manufacturing cGMP Oxycyte PFC for the study.
"In addition, we are seeking a partner to help us execute the remaining aspects of this trial because we believe that makes strategic sense and is in the best interest of our shareholders," Stern said.