Oxygen Biotherapeutics Inc. (OTCBB: OXBO) engages in marketing innovative pharmaceuticals and medical devices to monitor respiration in patients suffering from or associated with respiratory distress syndrome, stroke, myocardial infarction, surgery, trauma, malignant tumors and diabetes.
The company today announced it will submit an amended test protocol to the U.S. Food and Drug Administration, as well as in Canada, to cover the dose escalation studies of the company’s therapeutic oxygen carrier Oxycyte. The company plans on recruiting 40 traumatic brain injury (TBI) patients in each country to test the safety and efficacy of Oxycyte.
“Personally, I think that the extensive data we will collect in the dose escalation studies should be more than needed for proof-of-concept in both safety and efficacy. The advantage is that we should have the data we need much earlier, after each cohort of 10, rather than after 200 patients as it was previously planned. Another important advantage is that this approach could save us a substantial amount of money – perhaps as much as 50 percent compared to the original phase IIb design. Most importantly, having good data sooner could give us a much earlier opportunity to reach out to potential license partners,” said company chairman and CEO Chris J. Stern, DBA.
Oxygen Biotherapeutics’ multi-center studies will seek to determine the lowest dose of Oxycyte that reduces thrombocytopenia while providing clinical benefit in TBI. After receiving the assigned dose level, each patient will be followed and observed for six months.
Oxygen Biotherapeutics will file the amendment in a global format, allowing the company to submit the protocol in the United States, as well as abroad, within about 50 days. Patient enrollment is scheduled for the first quarter of 2009; and the company is negotiating whether or not to conduct an additional study in Switzerland.
The company will finance the escalation study partially with a previously-announced $1.9 million grant from the United States Department of Defense to M. Ross Bullock, M.D., Ph.D., of the University Of Miami Miller School Of Medicine, Department of Neurosurgery. According to the press release, Dr. Bullock is the principal investigator for the traumatic brain injury trial protocol with Oxycyte.
Let us hear your thoughts below:
