The U.S. Food and Drug Administration (FDA) is allowing Oxygen Biotherapeutics Inc. to resume patient testing on its experimental brain injury drug Oxycyte, nearly six years after the agency suspended clinical trials of the drug due to concerns about its use in patients with severe traumatic brain injuries (TBI).
TBIs are caused by a blow to the head or a penetrating head injury and interfere with normal brain functioning. About 52,000 people die from TBI in the United States each year, according to the Brain Trauma Foundation.
When someone suffers from a TBI his platelet count significantly drops in response to the injury. Platelets circulate in the blood and are involved in hemostasis, which leads to the formation of blood clots. A drop in platelets can lead to excessive bleeding, which can be fatal, especially for patients with TBI. Oxycyte is an artificial red blood cell substitute designed to carry oxygen, similar to hemoglobin.
There are no FDA approved drugs for TBI, though Oxygen Bio, formerly known as Synthetic Blood International, was paid more than $2 million by the U.S. Army in 2011 to conduct clinical trials on the treatment. The FDA had asked for additional information about the drug and its effect on the immune system and potential to raise the risk of deadly brain bleeds. Oxygen Bio submitted data from two studies last September.
The company is currently enrolling patients outside the United States to test the drug in patients with severe non-penetrating TBI. Oxygen Bio is also teaming up with the U.S. Navy to test the drug for decompression sickness, hemorrhagic shock, and wound treatment.