Oxygen Biotherapeutics Approved to Expand Trials for Traumatic Brain Injury
Oxygen Biotherapeutics, Inc recently announced it has received approval by the Drug Controller General of
Dr. Tim Bradshaw, Executive Vice President of Clinical Development at Oxygen Biotherapeutics, believes the addition of
“We are pleased that we received this approval and look forward to working with our new clinical sites,” added Chris Stern, Chairman and Chief Executive Officer of Oxygen Biotherapeutics. “Currently, we are exploring whether to amend the protocol to include patients with milder forms of TBI, and we 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 and patients.”
The STOP-TBI study is a double-blind, placebo controlled dose-escalation study designed to evaluate the safety, efficacy, and dosing parameters of Oxycyte PFC, a novel perfluorocarbon emulsion that is given intravenously to traumatic brain injury patients. The study’s first cohort has been completed and the database has been locked.
Headquartered in Morrisville, NC, Oxygen Biotherapeutics, Inc. is developing medical and cosmetic products that efficiently deliver oxygen to tissues in the body. The company has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier that is being formulated for both intravenous and topical delivery.
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