Oxygen Biotherapeutics, Inc has received a letter from the FDA that outlines what the agency termed a 'path forward' as a basis to resume clinical studies of Oxycyte in TBI. Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier.
The letter was in response to the company's request for formal dispute resolution that was submitted to the FDA Ombudsman's office. As a result, the Office of Blood Research and Review examined the reviewing division's decision to delay the start of a proposed phase-II dose escalation study of Oxycyte in traumatic brain injury (TBI).
"This outcome of the review is of great relief to us," said Chris J Stern, company chairman and CEO. "It is helpful because it now positions the FDA to participate with the company in the development of the recommended experimental protocols to ensure their alignment with the agency's suggested path forward. This gives us the best chance to demonstrate safety of Oxycyte sufficient to move ahead in TBI in the United States," said Stern.
"In the meantime, we are moving ahead with our planned dose-escalation TBI study outside the US. We have expanded the trial to now include up to six sites in Switzerland and we will announce another country soon. This approach will put us on what we see as the best and fastest track for Oxycyte's clinical development while meeting the needs of all our stakeholders."
Oxygen Biotherapeutics is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring.