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
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Department of Neurosurgery,
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